Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data
NOTE:Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The approval is based on the NIH’s clinical trial showing “promising results.”
An EUA is different than a full FDA approval
An EUA is based on an FDA evaluation of evidence and risks vs potential or known benefits of of “unproven” products during an emergency
The FDA states
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease
Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator
It was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use
KEY POINTS:
NIH Remdesivir Trial
RCT involving 1063 patients:
Adaptive COVID-19 Treatment Trial (ACTT)
Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)
Multicentered (including US, UK, and Singapore)
Started in February 2020
Current primary endpoint: Being well enough for hospital discharge or returning to normal activity level
Preliminary Data
Time to recovery
Median time to recovery: 11 days for remdesivir group vs 15 days for placebo group
31% faster time to recovery in remdesivir group vs placebo (p<0.001)
Mortality Rate
8.0% in remdesivir group vs 11.6% for the placebo group (p=0.059)
“Suggests benefit” but not statistically significant
Second (next) stage of trial
Remdesivir in combination with another agent | Likely to be a janus kinase inhibitor
One of the investigators (UK team) stated (April 30, 2020)
As far as the results are concerned, it’s cautious optimism
There is some effect but it is not a wonder effect
We have to find out when is the best time to give this drug, who benefits more
There is still a lot of data to come out of this trial
AAP Recommendations: L&D Guidance and Management of Infants Born to COVID-19 Positive Mothers
NOTE:Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
The AAP provides guidance on clinical issues related to the newborn when a mother has confirmed or suspected COVID-19. Neonates born to women with confirmed or pending COVID-19 results at delivery should be considered as persons under investigation (PUIs) for infection. The guideline also addresses particular areas of concern to healthcare professionals, such as PPE requirements for delivery
AAP specifically addresses the aerosolization of SARS-CoV-2 viral particles during delivery and states that, in addition to gown and gloves, N95 respiratory masks or air-purifying respirators that provide eye protection should be used
Rooming-In vs Separation
Mother with confirmed or suspected COVID-19 and well newborns can room-in
Risk of newborn infection is low if proper precautions are taken
A mother who is accutely ill may not be able to care for her infant
May be appropriate to temporarily separate mother and newborn or have the newborn cared for by non-infected caregivers in mother’s room
NICU Care of Exposed Infant
Admit to single-patient room
Ideal: Potential for negative pressure or air filtration system
If negative pressure unavailable or if individual space unavailable: Space by ≥6 feet and/or use air temperature-controlled isolettes
Intubation is an aerosol-generating procedure and therefore use either an N95 respiratory mask and eye protection goggles or an air-purifying respirator that provides eye protection
Mothers and Partners Visiting the NICU
If fully vaccinated who have then had an exposure
Do not exclude unless they develop symptoms consistent with SARS-CoV-2 infection
Confirmed COVID-19
Should not visit NICU infants while able to transmit SARS-CoV-2
Immunocompetent persons may be considered non-infectious if
Afebrile for 24 hours without use of antipyretics
At least 10 days have passed since symptoms first appeared (or, in the case of asymptomatic women identified only by obstetric screening tests, at least 10 days have passed since the positive test)
Symptoms have improved
Persons who are severely or critically ill with COVID-19
Should not enter the NICU until at least 20 days have passed since symptoms first appeared or first positive test
Severely immunocompromised and infected with SARS-CoV-2
Recommend consultation with your local infectious disease specialists for specific case management
Testing Newborns Prior to Discharge
Bathe newborns after birth to remove virus that may be on skin
Timing of testing for healthy newborns: At least once before discharge
24 hours of age
Repeat at 48 hours
Procedure
Use one swab: Swab throat and then nasopharynx
If infant is positive
Test using combined throat/nasopharynx specimens every 48 to 72 hour intervals until there are 2 consecutive negative tests
KEY POINTS:
Hospital Discharge
Base discharge on a center’s normal criteria
Discharge Planning Based on Newborn Test Results
If infant can’t be tested
Treat as if positive for the virus for the 14-day observation period
Mother should maintain precautions until she meets the criteria for non-infectivity (see ‘Related ObG Topics’ below)
Positive test results
No symptoms: Plan for frequent outpatient follow-up (phone, telemedicine or in-office) through 14 days after birth
Follow CDC precautions to prevent household spread from infant to caregivers (see ‘Primary Sources – Learn More’ below)
Negative test results
Ideally, discharge to designated healthy caregiver
Mother should
Maintain ≥6 foot distance when possible
Use a mask and hand hygiene when directly caring for the infant
The above transmission precautions should be used until
she has been afebrile for 24 hours without use of antipyretics
at least 10 days have passed since her symptoms first appeared (or, in the case of asymptomatic women identified only by obstetric screening tests, at least 10 days have passed since the positive test), and
symptoms have improved.
Other caregivers in the home who are have confirmed or suspected COVID-19
Should use standard procedural masks and hand hygiene when within 6 feet of the newborn until their own status is resolved
COVID-19, ACE Inhibitors and ARBs: Professional Guidance and Evidence Update
NOTE:Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
Coronavirus disease 2019 (COVID-19) is an infection caused by the SARS-CoV-2 virus. The virus is known to target the angiotensin converting enzyme 2 (ACE-2) co-receptor. Therefore, concern has been raised whether the use of common medications that impact ACE and the renin angiotensin system may also result in increased COVID-19 infection risk. Papers have been now been published demonstrating no increased risk with use of ACE inhibitors or angiotensin receptor blockers (ARBs).
Patients at higher risk for significant morbidity and mortality from COVID-19 infection include older patients, especially those with chronic medical conditions such as the following
Pulmonary disease
Cardiac disease
Kidney disease
Diabetes
Hypertension
It is unclear whether the above associations are independently related to pathogenesis, other associated comorbidities, or even treatment
These disorders themselves are not necessarily independent and often appear together in patients, particularly in the context of the metabolic syndrome
ACE inhibitors, ARBs and other renin angiotensin aldosterone system (RAAS) inhibitors are commonly used in patients who would be considered ‘at risk’ for COVID-19
Angiotensin Converting Enzymes
ACE-1 and ACE-2 are two major enzymes found in the renin-angiotensin system
ACE enzymes play a critical role in the balance of peptides in the angiotensin family
ACE-2 is found on
Epithelial cells in both respiratory and GI tracts
Cardiac and kidney cells
ACE Inhibitors and ARBs
ACE inhibitors and ARBs
Strongly influence angiotensin peptides
Increase ACE-2 activity in cardiac tissue
What We Currently Know about SARS-CoV-2 Infectivity
SARS-CoV-2 is covered with crown-like glycoprotein spikes (hence ‘corona’) comprised of 2 subunits
Subunit S1: Binds to ACE-2 on the cell surface
Subunit S2: Fuses with the cell membrane
TMPRSS2 (host enzyme): Promotes cellular entry of the virus
Do ACE Inhibitors and ARBs Increase Risk for COVID-19?
ACE inhibitors, ARBs and other renin angiotensin aldosterone system (RAAS) inhibitors are commonly used in patients who would be considered ‘at risk’ for COVID-19
Theoretical risk raised
Because ACE inhibitors and ARBs ‘may’ increase expression of ACE-2 leading to greater risk for virus to enter and infect cells, could these medication lead to increased risk for COVID-19 morbidity and/or mortality?
Possible benefit
Study from China showed that while hypertension is a risk factor for COVID-19 mortality, patients on ACE inhibitors and ARBs did better (see review in ‘Learn More – Primary Sources’ below)
Underlying mechanism is unclear, but there may be a biphasic pattern: (1) In phase 1, these medications could increase infectivity (2) In phase 2, ACE-2 downregulation by the virus may be the “hallmark” of COVID-19 progression and therefore medications that upregulate in the second phase may be of benefit
In addition, there is a hypothesis that ACE-2 also stimulates one of the angiotensin peptides (angiotensin-(1-7)) that has positive anti-inflammatory effects | Therefore, medications that stimulate ACE-2 could have a beneficial effect
Current Evidence
Zhang et al. (Circ Res, 2020)
Retrospective, multi-centered study | 1128 hospitalized patients with COVID-19 | ACE Inhibitors/ARB group: 188
After adjustment, detected risk for all-cause mortality was lower in the ACE Inhibitors/ARB group compared to the non-ACE Inhibitors/ARB group
Adjusted hazard ratio: 0.42 (95% CI, 0.19 to 0.92; p = 0.03)
These medications may be associated with a lower risk of all-cause mortality in the setting of COVID-19 compared to non-users
Reynolds et al. (NEJM, 2020)
12,594 tested | 5894 patients positive for COVID-19 | Severe in 17%
Hypertension history: 34.6% of tested patients | 59.1% were COVID-19 positive had a positive test | Severe in 24.6%
Authors conclude that there was no association with likelihood of a positive test or severity of illness
Mancia et al. (NEJM, 2020)
Population-based case–control study | 6272 patients with confirmed SARS-CoV-2 infection
Use of ARBs or ACE inhibitors did not show any association with Covid-19 overall or those with severe or fatal disease
Editorial (Jarcho et al. NEJM, 2020)
The accompanying editorial recognizes limitations inherent in observational data
However, these studies support professional guidance that recommend against altering these medications when indicated
Furthermore, the editorial authors state
Taken together, these three studies do not provide evidence to support the hypothesis that ACE inhibitor or ARB use is associated with the risk of SARS-CoV-2 infection, the risk of severe Covid-19 among those infected, or the risk of in-hospital death among those with a positive test.
KEY POINTS:
Recommendations
Guidance is based on the current lack of evidence that ACE inhibitors or ARBs increase risk of infection or result in a more severe course of COVID-19 disease
It is acknowledged that new data may result in a future update to these guidelines
Professional recommendations do not support stopping or changing medications for patients who are currently being treated with ACE inhibitors or ARBs
In addition, cessation is associated potential for significant harms including
Medical risk: Exacerbation of underlying medical conditions
Infection risk: Due to increased pharmacy encounters, visits for blood work etc.
The HFSA/ACC/AHA recommends
…continuation of RAAS antagonists for those patients who are currently prescribed such agents for indications for which these agents are known to be beneficial, such as heart failure, hypertension, or ischemic heart disease
In the event patients with cardiovascular disease are diagnosed with COVID-19, individualized treatment decisions should be made according to each patient’s hemodynamic status and clinical presentation
Therefore, be advised not to add or remove any RAAS-related treatments, beyond actions based on standard clinical practice
COVID-19 and Coagulopathy: ISTH Issues Guidance on Diagnosis and Management
NOTE:Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
The ISTH released guidance on the recognition and management of coagulopathy in the setting of COVID-19. The ISTH emphasizes the term ‘interim’ as the medical community continues to learn more about the clinical course of those infected with SARS-CoV-2. The stated goal of this guidance is
…to provide a risk stratification at admission for a COVID‐19 patient and management of coagulopathy which may develop in some of these patients, based on easily available laboratory parameters
Recommended Labs at Admission (decreasing order of importance)
D-dimers
Consider hospital admission for patients with markedly raised D-dimers even in absence of other severity symptoms
“Arbitrarily defined as three-four fold increase”
High levels indicate increased thrombin generation
Note: This guidance does not address pregnancy specifically | D-dimer is elevated in normal pregnancy (see ‘Learn More – Primary Sources’ below)
Prothrombin time (PT)
Current literature is demonstrating mild prolongation of PT at admission in ICU vs non-ICU cohorts (e.g., 12·2 s vs 10·7 s; Huang et al. Lancet, 2020)
Caution: Such “subtle changes” will not be as readily identified if PT is reported as INR
Thrombocytopenia
Unlike typical sepsis, thrombocytopenia at admission for COVID-19 was not as strong an indicator of sepsis mortality
The authors state that “thrombocytopenia at presentation may be but not consistent prognosticator”
Monitoring Coagulation Markers
Monitor D-dimers, platelet count, PT and fibrinogen to identify worsening coagulopathy
Worsening parameters: “More aggressive critical care support is warranted” including consideration of ‘experimental’ therapies and blood product support
Stable or improving parameters: Provides “added confidence for stepdown of treatment if corroborating with the clinical condition”
DIC
Importance of regular laboratory monitoring
Day 4: In one study (Tang et al. J Thromb Haemost, 2020), DIC was much more likely to develop on day 4 among nonsurvivors vs survivors (71.4% vs 0.6%)
Days 10 and 14: Statistically significant increase in D-dimer levels, and PT, and decrease in fibrinogen levels were likewise seen in nonsurvivors
KEY POINTS:
Management Points
Inhibition of thrombin generation may reduce risk for multi-organ failure in the setting of sepsis
Prophylactic LMWH
“Should be considered in ALL patients (including non-critically ill) who require hospital admission for COVID-19 infection, in the absence of any contraindications (active bleeding and platelet count less than 25 x 109 /L)”
Monitor closely if severe renal impairment is present
“Abnormal PT or APTT is not a contraindication”
Additional benefits of LMWH include
VTE prevention
Anti-inflammatory properties
Parameter Thresholds
Non-bleeding patients: Maintain
Platelet count >20 x 109/L
Fibrinogen >2.0 g/L
Bleeding patients (rare in setting of COVID-19): Maintain
Closely monitor patient for coagulopathy: Repeat every 2–3 days
D-dimer
PT
Platelet counts
Administer subcutaneous LMWH for all hospitalized patients
Evidence to support this practice in severe COVID-19 | “In view of the hypercoagulable state of patients with severe COVID-19, and the potential increased risk of thrombosis, we suggest that all patients with COVID-19 that are admitted to hospital should receive this prophylactic treatment in the absence of medical contraindications”
Be on alert for VTE
Consider VTE in the setting of rapid respiratory deterioration and/or high D-dimer concentrations
CT angiography or ultrasound of the venous system of the lower extremities
Note: If diagnostic testing is not possible and there are no bleeding risk factors, consider therapeutic anticoagulation | Experimental therapies such as plasma exchange, or administration of other anticoagulants or anti-inflammatory drugs should only be undertaken via clinical trials
Managing an Obstetric Office Practice During COVID-19
NOTE:Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
Boelig et al. (AJOG MFM, 2020) provide a helpful (and necessary) overview, including suggestions for managing obstetrical workflows during the COVID-19 pandemic. The focus is not only on MFM practice; the authors also provide multiple proposals that may ease congestion and limit viral spread. Note that the following summary reflects ‘Expert Review’. Professional society and organization COVID-19 guidelines may differ.
Triage via telehealth to determine if additional supportive care is required
Mild symptoms do not require in-person assessment
Self-isolate for 14 days (i.e., assume infection unless confirmed otherwise)
Use drive-through testing or stand-alone testing rather than in-person office visits/testing
If patient does come to the office and is symptomatic, assume infection | CDC recommends that
Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed
Healthcare personnel entering the room should use Standard and Transmission-based Precautions
Altering the Standard OB Visit Schedule
Visits Without Face-to-Face Interactions
Intake Visit
Can be done by telehealth unless urgency to visit
In general, the authors recommend taking advantage of telehealth opportunities if possible
16, 24 and 34 weeks
Use telehealth
Postpartum
Photos can be used to assess wounds and other issues (e.g., mastitis) and uploaded via patient portals
In-Person Antenatal Visit Schedule
<11 weeks
Telephone OB intake
Consider earlier if at risk for ectopic
11-13 weeks
Ultrasound for dating and aneuploidy screening (if not scanned previously | If proven viability, cfDNA (NIPS) could obviate need for ultrasound
OB labs
20 weeks
Structural fetal anatomy ultrasound
28 weeks
Appropriate labs (e.g., GDM screening) and vaccines
32 weeks
Ultrasound (if indicated)
36 weeks
Ultrasound (if indicated)
GBS/HIV screen
37 weeks until delivery
Weekly visits
Additional Considerations
Use home BP monitoring where possible
Use low volume blood drawing centers if feasible
KEY POINTS
The authors provide some general points and suggested abbreviated visit schedules for ultrasound and fetal assessment to limit exposure and protect the health of patients and obstetric professionals
MFM practices and obstetrical units may alter their routine scheduling patterns for high risk OB patients based on resources and local policies | The authors’ modified schedules can be found in ‘Learn More – Primary Sources’ below
Prenatal Ultrasound
Dating
cfDNA is an option for aneuploidy testing if patient has had an early first trimester ultrasound and viability is established
Anatomy (Early 2nd trimester to 22 weeks)
Consider limiting follow-up views to 4 to 8 weeks vs usual 1 to 2 weeks
If only a single view or 2 views are missing (example given: lumbar sacral spine not well seen but posterior fossa is within normal, which would strongly suggest absence of NTD)
BMI>40: Schedule later in pregnancy (e.g., 22 weeks) to avoid need for follow up due to missing views
Additional ultrasound testing
Third trimester growth scan: 32 weeks
previa/low lying placenta: 34-36 weeks
Authors suggest using telehealth for ultrasound counseling where possible, especially in the absence of a new onset finding
NSTs and BPPs
Authors suggest minimizing NST visits or using alternative fetal assessment methods where possible
NSTs 2x per week should be limited to IUGR with abnormal Doppler flows
NSTs initiated <32 weeks should be avoided when possible
Avoid NST and use BPP if a patient is already undergoing an ultrasound assessment
Kick counts
Consider as an alternative to NST in lower risk patients, such as
Women age 35 to 39
BMI>40 (uncomplicated)
Gestational hypertension or preeclampsia
Weekly office visit and daily home blood pressure monitoring
COVID-19, PPE and Second Stage of Labor: Current US Guidance
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
Multiple societies and experts have weighed in on whether second stage of labor and delivery warrants respirators (e.g., N95 masks) vs surgical masks in the setting of a patient with confirmed or suspected COVID-19. The lack of clarity currently revolves around whether the second stage of labor should be considered an aerosol-generating event. ACOG, SMFM and multiple other ObGyn societies have sent a letter to the CDC requesting clarification (summarized under ‘Key Points’ below).
CDC
CDC advises healthcare personnel to use
Gloves
Gowns
Airborne precautions
Eye protection (e.g., goggles or a face shield)
Face masks are an acceptable alternative when the supply chain of N95 respirators (or similar respirators that filter inspired air and offer respiratory protection) cannot meet the demand
NIOSH-approved filtering facepiece respirators, half facepiece or full facepiece elastomeric respirators, and powered air-purifying respirators (PAPRs) where feasible “might be considered”
However, they should not be used during surgery because exhaled air may contaminate the sterile field
If respirators are in short supply, priority should be given to aerosol-generating procedures (e.g., intubation)
CDC addresses alternatives in the setting of face mask shortages on the page entitled Strategies for Optimizing the Supply of Facemasks (see ‘Learn More – Primary Sources’)
CDC guidance states
Based on limited data, forceful exhalation during the second stage of labor would not be expected to generate aerosols to the same extent as procedures more commonly considered to be aerosol generating (such as bronchoscopy, intubation, and open suctioning)
Forceful exhalation during the second stage of labor is not considered an aerosol-generating procedure for respirator prioritization during shortages over procedures more likely to generate higher concentrations of infectious respiratory aerosols
When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with known or suspected COVID-19
ACOG
Healthcare providers should use PPE, including respirators or face masks, goggles, gowns and gloves | N95 respirators should be used for aerosol-generating procedures
ACOG states that “COVID-19 infection is highly contagious, and this must be taken into consideration when planning intrapartum care”
In addition to wearing appropriate PPE, respirators (e.g., N95 masks) should be worn by “All medical staff caring for potential or confirmed COVID-19 patients” when available
In the setting of limited infection protections “physicians are not ethically obligated to provide care to high-risk patients without protections in place”
PPE: ACOG restates CDC guidance
Respirators (e.g., N95 respirators) should be used when caring for patients with confirmed or suspected COVID-19
Aerosol-generating procedures should be prioritized during shortages
ACDC currently does not consider second stage an aerosol-generating procedure and adds the following
ACOG continues to review questions and data regarding the potential for aerosolization in the context of forceful exhalation during the second stage of labor
SMFM/SOAP
Respirators (N95 masks)
Should be used in any room where there is performance or anticipation of aerosol-generating procedure for patient with confirmed COVID-19 or PUI
Examples of potential aerosol-generating events include
Cesarean deliveries
PPH
Intubation
Second stage of labor
Suggestions to limit exposure include
Use of surgical drapes as an added barrier during second stage and delivery | Check with local infection control regarding reuse of N95 masks
In addition, SMFM/SOAP believes it is “reasonable” to
…consider N95 mask use for HCWs caring for patients with suspected or confirmed COVID-19 in the second stage of labor, including specifically HCWs with significant and prolonged exposure to such patients
As with all resource considerations and potential supply and demand imbalances, the ability to adhere to this suggestion will need to be evaluated on an institutional level. It is acknowledged that this suggestion is above and beyond current CDC recommendations
SOGH
The SOGH COVID-19 statement is based on the following
Obstetricians are frontline personnel
Asymptomatic patients on L&D can potentially infect frontline personnel, especially as there is close contact between patients and healthcare professionals during labor
The science behind COVID-19 transmission continues to evolve
As a result of the above, SOGH recommends
Universal use of hospital masks on Labor and Delivery, for staff, patients and visitors
Universal testing for Covid19 of all pregnant women and their chosen support person/s on Labor and Delivery, where available
Use of full PPE, including N95 masks and face shields, for the second stage of labor for all Covid positive women and persons under investigation or for all women, when universal testing is not available
AAP
AAP provides PPE guidance in the setting of a birth when the mother is COVID-19 positive
Aside from gown and gloves, AAP recommends that staff should use
Either an N95 respiratory mask and eye protection goggles or with an air-purifying respirator that provides eye protection
The protection is needed due to the likelihood of maternal virus aerosols and the potential need to perform newborn resuscitation that can generate aerosols
AWHONN
AWHONN recommends the following based on the fact that data on second stage is still limited and universal testing is not widely available
Healthcare personnel caring for women in the second stage of labor are in close contact for long periods of time to provide support for breathing and pushing
AWHONN recommends all healthcare personnel wear appropriate PPE during the second stage of labor, including use of N95 masks when caring for women who are known or suspected (PUI) COVID-19
Until universal testing is available, health care personnel should have the option to use N95 masks when caring for all women in the second stage of labor
The letter requests clarification from the CDC regarding PPE use on L&D, specifically second stage of labor
The societies raise concern that the current CDC recommendations are
…being interpreted as suggesting that obstetric care clinicians need not wear N95 masks and face shields when attending to patients with confirmed or suspected COVID-19 during the second stage of labor
We appreciate your clarification that the CDC recommends use of such PPE and look forward to working with you to amplify this message
‘Expert Review’
Boelig et al. AJOG MFM, 2020
Some centers consider N95 masks to be appropriate
In addition to droplet precaution PPE for any patients with suspected or confirmed COVID-19 and
For any patient, regardless of respiratory symptoms, during indispensable aerosolizing procedures, including second stage of labor
Palatnik and McIntosh. Am J Perinatol, 2020
The authors recommend that healthcare professionals during second stage be provided with N95 respirators
The authors make the point that there are important factors to consider specifically regarding the second stage of labor and patients with suspected or confirmed COVID-19
Time: To avoid cesarean delivery, patients can be allowed up to 4 hours (nulliparous) and 3 hours (multiparous) in second stage
Distance: Healthcare personnel will likely be within 6 feet of the patient and likely closer when patient is pushing
Furthermore, the authors state that that patients will be “exerting extreme effort during the second stage of labor and frequently blow out their breath, cough, shout, and vomit, all of which put the health care team at risk”
COVID-19: The SMFM/SOAP Guidelines for Labor and Delivery
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
SMFM and Society for Obstetric and Anesthesia and Perinatology (SOAP) have released COVID-19 guidelines for obstetric professionals, including anesthesiologists. The following are highlights. The complete document link can be found in ‘Learn More – Primary Sources’. The guideline is not proscriptive with an understanding that they “may not apply in your clinical setting”
Personnel should maintain distance (>6 feet if possible)
Limit duration of encounter
Limit number of support persons
Develop policies locally | There may be state restrictions as well
Screen visitors for symptoms of respiratory illness before entering the healthcare facility
Provide exceptions for bereavement
Log staff entering and leaving cohorted rooms
Consider staggering staff schedule to limit exposure
Example: Rotate telehealth team with in-person team every 2 weeks
Testing of women admitted to labor and delivery
Prioritize pregnant women with exposure to or symptoms of COVID-19
Universal testing “may be considered due to the potential for asymptomatic patients to present, particularly in areas of high community prevalence”
Patient Rooms
Confirmed COVID-19 and PUI: “Ideally” should be placed in isolation room
Airborne infection isolation rooms
In general
Droplet and contact precautions
If aerosol-generating procedure is anticipated
Single-patient negative-pressure rooms | Minimum of 6 air changes per hour
“Crash Rooms”
Negative-pressure ORs should not have open surgical equipment
PPE for Health Care Workers
Women with Confirmed Covid-19 Or PUI
Should wear a surgical mask
Health Care Workers Caring for Women Who are Positive for SARS-CoV2 or PUIs
Use droplet and contact precautions with eye protection: Gown | Gloves | Surgical mask | Face shield or goggles
High-risk obstetrical scenarios
Use respirators (e.g., N95 masks) in any room where there is performance or anticipation of aerosol generating procedure (e.g., intubation)
Obstetrical examples include
Cesarean deliveries
Twin vaginal deliveries
Women brought to OR for management of PPH
Intubation (actual or anticipated)
Second stage of labor and deep respiratory effort
SMFM/SOAP states that healthcare workers
…should use N95 (or facemasks if N95 is not available), eye protection, gloves, and gowns during the second stage of labor, in addition to other personal protective equipment that may be typically indicated for labor and delivery
Surgical drapes could be used as an additional physical respiratory droplet barrier during the second stage and at delivery
KEY POINTS:
Preterm Medications
Antenatal corticosteroids
Use with caution in ICU/acute care setting
Balance risks and benefits and adjust protocols accordingly (e.g., >34 weeks and repeat courses)
Magnesium for fetal neuroprotection
Concern regarding maternal respiratory depression | Adjust accordingly based on clinical scenario, including gestational age and increasing maternal oxygen demands
Assess renal function | If mild respiratory distress, single 4 g bolus “may serve as an alternative”
NSAIDs restriction
Document considers restricting NSAIDs to be controversial because data lacking to support this practice
Prenatal ultrasonography
Use in settings where sonography would likely impact care
Labor and Delivery
Follow standard guidelines for the following practices (based on availability, which may change over time)
Amniotomy
Internal monitoring (may change with more data but currently no evidence that there is an increased risk for transmission)
Operative vaginal deliveries
Magnesium for preeclampsia/seizure prophylaxis
In absence of severe features of preeclampsia, “avoidance of magnesium seems prudent”
Be cognizant of potential renal dysfunction and adjusts dosing accordingly
Epidural
Consider early epidural to mitigate risks of general anesthesia including increased risk of aerosol-generating procedures such as intubation
Nitrous Oxide
Currently, limited data regarding use of nitrous oxide in patients with COVID-19
Patients with confirmed COVID-19 | Suspected COVID-19 | Unconfirmed COVID-19 negative status
“…may consider suspending use of nitrous oxide”
Patients with COVID-19 confirmed negative result
Nitrous oxide remains an option
Oxygen for fetal indications
While considered controversial, “suspend” use of high flow nasal cannula or face mask | Consider oxygen in the setting of maternal hypoxia
Worsening maternal respiratory status
Uterine decompression to improve maternal respiratory status
Data are unclear
Risk for fetal hypoxemia
Must be balanced against risks of preterm birth and maternal compromise
Postpartum Care
CDC recommendation regarding mother/infant separation has been updated since SMFM/SOAP Statement posted
CDC guideline now recommends that separation be based on ‘shared decision making’ | For those mothers who wish to room in, use mask/gloves and maintaining bassinet distance
Use expedited testing to determine COVID-19 status
Breastfeeding
Breastfeeding (with appropriate precautions) or pumping for women for confirmed COVID-19 or PUI is recommended
The document notes there may be risk to infant associated with direct breast feeding
NSAIDs
Increased risk with opioids vs NSAIDs
The document states “For women who are asymptomatic, mildly symptomatic, or moderately symptomatic who require analgesic medication beyond acetaminophen, nonsteroid anti-inflammatory drugs (NSAIDs) should be used if there are no other contraindications because systemic opioids likely pose more clinical risks”
Postpone postpartum tubal ligations if alternatives available
Circumcisions
Infants are considered PUIs
Decision “should be made in communication with the pediatric team, and appropriate PPE must be worn”
Ultrasound and COVID-19: AIUM and WFUMB Guidance on Transmission Precautions
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date
SUMMARY:
Various organizations have released documents to help ultrasound units navigate practical issues during the COVID-19 pandemic. The American Institute of Ultrasound in Medicine (AIUM) has released guidance, adapted from the World Federation for Ultrasound in Medicine and Biology (WFUMB). Due to the lack of data, the authors of these documents point out that statements should be considered ‘suggestions’ vs evidence-based guidance. In addition, they note that individual ultrasound practices should refer to their local governments and/or CDC.
General Precautions
“Implement both standard and transmission-based precautions, regardless of suspected or confirmed COVID-19”
Transmission-based precautions for ultrasound practitioners include
Surgical mask | Gloves | Gown | Eye protection
Consider every patient to be potentially SARS-CoV-2 infected
To limit risk of transmission
Lengthen appointment times
Minimize patients in waiting room and maintain ≥6 foot spacing
Give patients and caregivers masks on arrival
No visitors in the exam room
AIUM includes students and trainees among those who should not be in the exam room
Rooms should be cleaned and disinfected as if each person has COVID-19
If patient known or suspected COVID-19 positive
Respiratory protection
Use respirators (e.g., N95) rather than surgical masks when exposed to aerosol-generating procedure (e.g., intubation) especially in ICU
Eye protection
Gloves
Gowns (in case of shortage, prioritize for aerosol-generating procedures)
AIUM states
As ultrasound practitioners are in close contact with patients, surgical facemasks are essential to offer protection
These must be put on before entry into the patient room or care area
When available, N95 respirators or respirators that offer a higher level of protection should be used instead of a facemask when performing or present for an aerosol-generating procedure, particularly for use in the intensive care unit
KEY POINTS:
Hand hygiene
Perform hand hygiene before and after the following
All patient contact
Contact with potentially infectious material (e.g. linen from patient room)
Removing PPE (including gloves)
Method
Alcohol-based hand rub (60-95% alcohol) or
Soap and water (≥20 seconds) | Use soap prior to alcohol-based hand rub if hands soiled
Use latex free disposable gloves during the exam | Change between each patient
One hand on transducer and other on keyboard
Hand on keyboard is considered ‘semiclean’ because there may potentially be virus caught in the crevices of the machine | Use this ‘semiclean’ hand to apply gel
Between cases: Clean bottle and wipe down touched surfaces with low-level disinfectant (LLD)
Additional precautions include
Ultrasound practitioners with underlying health problems (i.e., those disorders included in ‘at risk’ category): Limit exposure where possible
Ensure infection control training and fit testing for respirators (e.g. N95) if needed
Patients in isolation (confirmed or suspected COVID-19)
Use PPE prior to entering room
Respirator (e.g., N95) or facemask | goggle or face protective shield | Surgical gown | Gloves
Transducer Cleaning and Disinfection
Non-critical devices (low risk)
Transducers that come into contact with intact skin
Us a low or intermediate level disinfection, which will denature most bacteria, some fungi and some viruses, such as COVID-19, influenza A and human immunodeficiency virus (HIV)
Semi-critical devices (medium risk)
Transducers that come into contact with non-intact skin, blood, body fluids and mucous membranes (e.g., vaginal probes)
Use a high-level disinfection (HLD) method
Single-use transducer cover is mandatory
Critical devices (high risk)
Transducers used for invasive procedures (e.g. needle guidance during biopsies, aspirations, drainages) and possible risk of blood or body fluid exposure
Use sterilization (if compatible) or HLD
Sterile transducer covers are mandatory
The WFUMB states that the only change in the context of COVID-19 is that
…all external probes must undergo cleaning followed by low level disinfection to denature any presence of SARS-CoV-2 e.g. transducers used for transabdominal scanning, lung ultrasound or in the pediatric or emergency department setting
It is important to note that the low level disinfectant for COVID-19 is approved for use on ultrasound transducers and has proven viricidal efficacy
The Law and Limits of Quarantine during Covid-19 Pandemic
Covid-19 has circumnavigated the globe at a rapid pace. Governments and healthcare officials are struggling with the mounting waves of cases and how to effectively manage the crisis. Public movement has been, and continues to be, a prime area for management. Quarantines and travel bans have been implemented during the pandemic, and are subject to change.
Public Health Definitions
Quarantine
In public health practice, “quarantine” refers to the separation of persons (or communities) who have been exposed to an infectious disease
Isolation
In contrast, isolation applies to the separation of persons who are known to be infected
Legal Definition (US Law)
US law uses the word “quarantine” to refer to both types of interventions and travel limits
Isolation and quarantine can be voluntary or imposed by law
States have the power and authority to implement these restrictions in response to a public health threat. For example, the tristate area of New York, New Jersey, and Connecticut have a coordinated approach of asking its residents to ‘self-quarantine’ at home even if healthy, preventing large gatherings, and closing nonessential retail businesses.
Federal government can intervene as well, but its power is limited. Quarantine is an option at the federal level if there is a concern related to disease spread over state lines or national borders. For example, nonessential travel between the United States and its neighbors Mexico and Canada has been restricted. In general, courts will be reluctant to interfere unless the quarantine is unreasonable or appears motivated by racial animus. For example, a quarantine during the bubonic plague of 1900 in San Francisco was struck down as being racially motivated and not suited to prevent spread of disease. On the other hand, two California universities were permitted to quarantine faculty and students during a measles outbreak.
While these measures of social distancing are necessary, immediate funding for medical supplies, PPE, and testing kits, along with expansion of hospital bed numbers (e.g., reopening of closed hospitals or developing temporary facilities) are vital to stemming the wave of morbidity and mortality that is flooding the U.S. healthcare system. As of this writing, Congress has authorized several aid packages that mandate private health plans to provide coverage for COVID-19 diagnostic testing, including the cost of a provider, urgent care center, and emergency room visits in order to receive testing; coverage without cost sharing for COVID-19 testing and screening provided during a telehealth office visit; and approved personal respiratory protective devices as covered countermeasures.
This topic will be updated to reflect significant policy shifts.
New York State Modifies and Suspends Laws Related to Medical Oversight and Liability During COVID-19 Pandemic
Governor Andrew Cuomo issued an executive order on March 23, 2020 that modified certain sections of the state’s education laws to eliminate any obstacle to the provision of supplies and medical treatment, in order to ensure that the New York healthcare system has adequate capacity to provide care to all who need it
Some modifications and suspensions include
To allow any emergency medical treatment protocol development or modification to occur solely with the approval of the Commissioner of Health
To permit a physician assistant to provide medical services appropriate to their education, training and experience without oversight from a supervising physician, without civil or criminal penalty related to a lack of oversight by a supervising physician
To permit a specialist assistant to provide medical services appropriate to their education, training and experience without oversight from a supervising physician, without civil or criminal penalty related to a lack of oversight by a supervising physician
To permit a nurse practitioner to provide medical services appropriate to their education, training and experience, without a written practice agreement, or collaborative relationship with a physician, without civil or criminal penalty related to a lack of written practice agreement or collaborative relationship with a physician
To provide that all physicians, physician assistants, specialist assistants, nurse practitioners, licensed registered professional nurses and licensed practical nurses shall be immune from civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the State’s response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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