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 CDC has provided guidance on both viral testing for SARS-CoV-2 as well as the role of antibody testing. Testing for the presence of the virus during the pandemic remains the current diagnostic standard. While antibody testing can play a role for public health teams to understand the spread of the disease, currently its use as a diagnostic test for individuals remains limited. A COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests.
Viral Testing
Specimen Collection
Obtain an upper respiratory specimen for initial diagnostic testing
A nasopharyngeal (NP) specimen collected by a healthcare professional or
An oropharyngeal (OP) specimen collected by a healthcare professional or
A nasal mid-turbinate swab collected by a healthcare professional or by a supervised onsite self-collection (using a flocked tapered swab) or
An anterior nares (nasal swab) specimen collected by a healthcare professional or by onsite or home self-collection (using a flocked or spun polyester swab) or
Nasopharyngeal wash/aspirate or nasal wash/aspirate (NW) specimen collected by a healthcare professional
Lower respiratory tract specimens
Collect and test sputum in patients who develop a productive cough | Induction of sputum is not recommended
Under certain clinical circumstances (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen
How is SARS-CoV-2 RNA Testing Performed?
RT-PCR
Usually performed using real-time reverse transcription polymerase chain reaction (RT-PCR)
Qualitative detection of RNA
Multiple tests on the market that can target various genes
A positive test can only determine presence of SARS-CoV-2 RNA and not whether the virus is intact and capable of infecting others
Antigen
Antigen tests can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs
The benefit of antigen testing is speed, with results potentially available within minutes
However, antigen tests, while very specific for the virus, are not as sensitive as molecular PCR tests
Positive antigen results: Highly accurate but higher chance of false negatives | Negative antigen results may still need PCR confirmation prior to treatment decisions or to prevent inadvertent spread of SARS-CoV-2
Note: Prior receipt of a COVID-19 vaccine should not affect the results of SARS-CoV-2 viral tests (NAAT or antigen)
Breath Sample Analysis
FDA has issued an emergency use authorization (EUA) for a diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection
Test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests
Results available in <3 minutes
Diagnostic Testing
Signs or Symptoms of COVID-19
Positive test
NAAT: Indicates infection regardless of vaccine status
Positive antigen test result may need confirmatory testing if the person has a low likelihood of SARS-CoV-2 infection (e.g., no known exposure to a person with COVID-19 within the last 14 days or is fully vaccinated or has had a SARS-CoV-2 infection in the last 3 months)
Isolate if positive test: Discontinue isolation 5 days after symptom onset and at least 24 hours after the resolution of any fever (without the use of fever-reducing medications) | Continue to wear mask around others for 5 additional days
Some individuals may require extended isolation and precautions (e.g., severely immunocompromised)
Testing is not recommended to determine when infection has resolved
Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation
Negative test
If symptoms are consistent with COVID-19, may be a false negative | Isolation and further discussion with healthcare professional recommended
Testing to determine resolution of infection
May be appropriate for severe illness or immunocompromise
“For all others, a test-based strategy is no longer recommended except to discontinue isolation or precautions earlier than would occur under the symptom-based strategy”
Screening Testing
No Symptoms and No Close Contact with Someone Known to Have a COVID-19 Infection
Asymptomatic or presymptomatic infection contribute to community SARS-CoV-2 transmission
May help with re-opening of businesses, communities, and schools
Point-of-care tests (e.g., antigen tests) can be particularly helpful due to short turn-around times
Quarantine not required while results are pending
Examples of screening programs
Testing employees in a workplace setting
Testing students, faculty, and staff in a school or university setting
Testing a person before or after travel
How Early Will a Test Be Positive and How Long Until Negative?
In patient with COVID-19 infection who tested positive using a nasopharyngeal swab
Earliest detection: Day 1 of symptoms
Peak levels highest within week 1 and therefore probability of detection will be highest during that time
Viral load declines by week 3 and therefore virus more likely to be undetectable in to week 4
Infection severity: More virus may be present in patients with severe disease and therefore it may take longer to obtain a negative test result vs someone with a mild COVID-19 infection
Performance of RT-PCR Viral Tests
RT-PCR specificities are close to 100% because they target specific RNA sequences of the SARS-CoV-2 virus
False negative results may be due to
Inappropriate timing of collection vs symptom onset
Poor sampling technique (need to sample at the back of the nose)
False positive results may occur due to lab error or contamination
However, even with good analytic performance, PPV and NPV are related to prevalence and therefore can differ between geographic regions
In a setting with high COVID-19 prevalence, a negative test does not necessarily rule out the possibility that an individual is infected with SARS-CoV-2
Antibody Testing
General CDC Antibody Guidance
According to the CDC
Antibody testing does not replace virologic testing and should not be used to establish the presence or absence of acute SARS-CoV-2 infection
Antibody testing is not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination, to assess the need for vaccination in an unvaccinated person, or to determine the need to quarantine after a close contact with someone who has COVID-19
Some antibody tests will not detect the antibodies generated by COVID-19 vaccines
Because these vaccines induce antibodies to specific viral protein targets, post-vaccination antibody test results will be negative in persons without history of previous infection, if the test used does not detect antibodies induced by the vaccine
In general, antibodies will be detectable 7 to 14 days after illness onset and will be present in most people by 3 weeks
Infectiousness likely decreased by that time
Evidence suggests some degree of immunity will have developed
IgM and IgG can appear together, usually within 1 to 3 weeks
IgG antibodies appear to persist for at least several months
Some individuals may be infected but will not develop antibodies
Neutralizing antibodies can also be identified and are associated with immunity
FDA requires companies providing antibody testing to obtain an EUA
What Are the Different Types of Antibody Tests?
Antigenic Targets
Spike glycoprotein (S): Present on viral surface and facilitates virus entry
Nucleocapsid phosphoprotein (N): Immunodominant and interacts with RNA
Protein targeting is important to reduce cross-reactivity (cause of false positives which may occur with other coronaviruses like the common cold) and improve specificity
Types of Antibody Testing
Binding antibody detection that use purified SARS-CoV-2 (not live virus)
Point-of-care (POC) tests
Laboratory tests that usually require skilled personnel and specialized equipment
Neutralizing antibody detection (none currently FDA authorized)
Serum or plasma is incubated with live virus followed by infection and incubation of cells
Can take up to 5 days to complete the study
When Can Antibody Testing be Helpful?
Antibody testing may be helpful in the following situations
Seroconversion: In a patient who did not receive a positive viral test
A positive antibody test at least 7 days following acute illness onset but a previous negative antibody test may indicate new onset SARS-CoV-2 infection
To support a diagnosis in the presence of a complex clinical situation, such as patients who present with COVID-19 complications (e.g., multisystem inflammatory syndrome and other post-acute sequelae of COVID-19)
Note: Due to antibody persistence, a single positive antibody test result may reflect previous SARS-CoV-2 infection and not a recent illness
Clinical, occupational health, and public health purposes, such as serologic surveys
Vaccination and Test Interpretation
In a person never vaccinated
testing positive for antibody against either N, S, or RBD indicates prior natural infection
In a vaccinated person
Testing positive for antibody against the vaccine antigen target, such as the S protein, and negative for other antigen: Suggests vaccine-induced antibody and not SARS-CoV-2 infection
Testing positive for any antibody other than the vaccine-induced antibody, such as the N protein: Indicates resolving or resolved SARS-CoV-2 infection that could have occurred before or after vaccination
The CDC states that
SARS-CoV-2 antibodies, particularly IgG antibodies, might persist for months and possibly years
Therefore, when antibody tests are used to support diagnosis of recent COVID-19, a single positive antibody test result could reflect previous SARS-CoV-2 infection or vaccination rather than the most recent illness
COVID-19: Category Definitions, Symptoms and Those at Increased Risk
NOTE: Information and guidelines may change rapidly. Check in with listed references in ‘Learn More – Primary Sources’ to best keep up to date. This summary has been updated with the latest CDC guidelines on when to end quarantine.
SUMMARY:
The novel coronavirus, named SARS-CoV-2, is the pathogen underlying the pandemic (a global outbreak of disease). The disease associated with this virus has been officially named COVID-19. Coronaviruses represent a large family of viruses. They can cause human illness, but many are found in animals and, rarely, animal coronaviruses can evolve and infect people as was the case in previous infectious outbreaks such as MERS and SARS.
Test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test)
No symptoms that are consistent with COVID-19
Mild illness
Have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell)
No shortness of breath, dyspnea, or abnormal chest imaging
Moderate illness
Evidence of lower respiratory disease during clinical assessment or imaging and oxygen saturation (SpO2) ≥94% on room air at sea level
Severe illness
SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, a respiratory rate >30 breaths/min, or lung infiltrates >50%
Critical illness
Respiratory failure, septic shock, and/or multiple organ dysfunction
Note: SpO2 is a key parameter for defining the illness categories listed above | Pulse oximetry has important limitations (e.g., skin pigmentation, thickness or temperature) | Clinicians who use SpO2 when assessing a patient must be aware of those limitations and conduct the assessment in the context of that patient’s clinical status
Pregnancy: Oxygen supplementation in pregnancy generally used when SpO2 <95% on room air at sea level to accommodate the physiologic needs of mother and fetus
Symptoms
Incubation period
Time from exposure to development of symptoms: 2 to 14 days
Delta variant studies: Mean incubation period of 4.3 days (see ‘Learn More – Primary Sources Below) which was shorter than initial variants (5.0 days)
Omicron variant studies: Median incubation period of 3 to 4 days
Signs and Symptoms
Fever or chills
Cough
Shortness of breath or difficulty breathing
Fatigue
Muscle or body aches
Headache
New loss of taste or smell
Sore throat
Congestion or runny nose
Nausea or vomiting
Diarrhea
Additional points regarding presentation
Older adults: Especially those with comorbidities may have delayed presentation of fever and respiratory symptoms
Fatigue, headache, and muscle aches (myalgia) are among the most commonly reported symptoms in people who are not hospitalized
Sore throat and nasal congestion or runny nose (rhinorrhea) also may be prominent symptoms
GI symptoms may be relatively common
Nausea, vomiting or diarrhea may occur prior to fever and lower respiratory tract signs and symptoms
Loss of smell (anosmia) or taste (ageusia) has been commonly reported, especially among women and younger or middle-aged patients
Those at Risk Based on Evidence (CDC)
Age
The CDC states
Age is the strongest risk factor for severe COVID-19 outcomes. Approximately 54.1 million people aged 65 years or older reside in the United States; in 2020 this age group accounted for 81% of U.S. COVID-19 related deaths, and as of September 2021 the mortality rate in this group was more than 80 times the rate of those aged 18-29
Higher Risk: Meta-analysis or systematic review demonstrates good or strong evidence
Asthma
Cancer
Cerebrovascular disease
Chronic kidney disease*
Chronic lung diseases limited to
Interstitial lung disease
Pulmonary embolism
Pulmonary hypertension
Bronchiectasis
COPD (chronic obstructive pulmonary disease)
Chronic liver diseases limited to
Cirrhosis
Non-alcoholic fatty liver disease
Alcoholic liver disease
Autoimmune hepatitis
Cystic fibrosis
Diabetes mellitus, type 1 and type 2*‡
Disabilities‡
Attention-Deficit/Hyperactivity Disorder (ADHD)
Cerebral Palsy
Congenital Malformations (Birth Defects)
Down syndrome
Limitations with self-care or activities of daily living
Learning Disabilities
Spinal Cord Injuries
See ‘Learn More – Primary Care’ CDC reference that includes extensive list for included disabilities
Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
HIV (human immunodeficiency virus)
Mental health disorders limited to
Mood disorders, including depression
Schizophrenia spectrum disorders
Neurologic conditions limited to dementia‡
Obesity (BMI ≥30 kg/m2 or ≥95th percentile in children)*‡
Primary Immunodeficiencies
Pregnancy and recent pregnancy
Physical inactivity
Smoking, current and former
Solid organ or hematopoietic cell transplantation
Tuberculosis
Use of corticosteroids or other immunosuppressive medications
Suggestive Higher Risk: Underlying medical condition or risk factor that neither has a published meta-analysis or systematic review nor completed the CDC systematic review process
Children with certain underlying conditions
Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
Sickle cell disease
Substance use disorders
Comorbidities with mostly case series, case reports, or, if other study design, the sample size is small
Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
Sickle cell disease
Substance use disorders
Thalassemia
Mixed Evidence: Meta-analysis or systematic review is inconclusive, either because the aggregated data on the association between an underlying condition and severe COVID-19 outcomes are inconsistent in direction or there are insufficient data
Alpha 1 antitrypsin deficiency
Bronchopulmonary dysplasia
Hepatitis B
Hepatitis C
Hypertension*
Thallassemia
Footnotes:
* indicates underlying conditions for which there is evidence for pregnant and non-pregnant people
‡ underlying conditions for which there is evidence in pediatric patients
Can High Dose Nitric Oxide Improve Respiratory Function in Pregnant Women with Severe COVID-19?
PURPOSE:
There is limited data on how best to manage respiratory failure in pregnant women with COVID-19
Safaee Fakhr et al. sought to determine if administering high concentrations of nitric oxide could improve the clinical course of pregnant women with respiratory failure
METHODS:
Case series (April to June 2020)
6 pregnant patients admitted with severe or critical COVID-19
Patients received high-dose (160–200 ppm) nitric oxide by mask twice daily
Treatment sessions lasted 30 minutes to 1 hour
For those patients requiring mechanical ventilation, the high dose regimen was stopped and restarted after extubation | During intubation, the patients received continuous low dose nitric oxide through the ventilator
RESULTS:
Total of 39 treatments
Cardiopulmonary function improved with administration of nitric oxide
Systemic oxygenation: Improved following each administration session in hypoxemic patients
Tachypnea: Reduced among all patients each session
3 deliveries while in hospital
4 neonates
28-day follow-up: All mothers and infants in good condition at home
3 remaining patients:
Discharged home and still pregnant at time of publication
There were no adverse events documented
CONCLUSION:
While acknowledging the small cohort size, the authors also conclude that
Nitric oxide at 160–200 ppm is easy to use, appears to be well tolerated, and might be of benefit in pregnant patients with COVID-19 with hypoxic respiratory failure
Pregnant Women with COVID-19 at Time of Delivery: NYC Cohort Characteristics and Outcomes
BACKGROUND AND PURPOSE:
Khoury et al. (Obstetrics & Gynecology, 2020) characterized clinical features and disease course among the initial cohort of pregnant women during the COVID-19 pandemic in New York City admitted for delivery
METHODS:
Prospective cohort study (March 13 to April 12, 2020 with follow-up completed April 20, 2020)
Setting
Five New York City medical centers
Participants
Pregnant women admitted for delivery
Confirmed COVID-19
Study design
Data collected: Demographics | Presentation | Comorbidities | Maternal and Neonatal outcomes | COVID-19 clinical course
COVID-19 cases were defined as
Asymptomatic
Mild: no additional oxygen supplementation required
Critical: Respiratory failure | Septic shock | Multiple organ dysfunction or failure
RESULTS:
241 women included
Asymptomatic on admission: 61.4% | 69% remained asymptomatic
Clinical status at time of hospitalization for delivery
Mild: 26.5%
Severe: 26.1%
Critical: 5%
Singleton preterm birth rate: 14.6%
Critical outcomes
ICU admission: 7.1% of women (17 women)
Intubation during delivery: 3.7% (9 women)
Maternal deaths: 0 women
BMI ≥30 associated with COVID-19 severity (P=0.001)
Cesarean delivery rates
Severe COVID-19: 52.4%
Critical COVID-19: 91.7%
Linear trend across COVID-19 severity groups for cesarean risk (P<.001)
245 liveborn neonates
Resuscitation at delivery beyond normal requirements: 30%
NICU admission: 25.7% | Hospitalization <2 days in 62.4%
Newborn outcomes
Prematurity and low birth weight: 8.7% (most common complications)
RDS: 5.8%
No complications: 79.3%
97.5% of newborns tested negative for SARS-CoV-2 at 24 to 96 hours
IUFD: 2 cases
Case 1: 38 weeks without fetal movement | Symptoms of COVID-19 pneumonia including chest imaging | No supplemental oxygen required | Patient declined autopsy and further work up for COVID-19 | No abnormalities were seen on placental pathology
Case 2: 29 weeks of gestation | FGR <1%tile | HELLP syndrome | Severe COVID-19 pneumonia
CONCLUSION:
Majority of pregnant women admitted for delivery were asymptomatic for COVID-19
Approximately 1/3 remained asymptomatic
Obesity was associated with COVID-19 severity
For women with COVID-19 (particularly severe and critical) there is an increased risk for cesarean and preterm birth
Does Hydroxychloroquine Provide Benefit in Nonhospitalized Patients with Early COVID-19 Infection?
PURPOSE:
Skipper et al. (Annals of Internal Medicine, 2020) sought to determine if hydroxychloroquine is of benefit to individuals with COVID-19 early in their clinical course
METHODS:
Multisite, international, randomized, double-blind, placebo-controlled trial (March 22 through May 20, with final hospital outcomes available June 15, 2020)
40 states (US) | 3 provinces (Canada)
Researchers collected self-reported survey data using the Research Electronic Data Capture (REDCap) system | Outreach traditional and through social media
Participants
Nonhospitalized | ≤4 days of symptoms with
Laboratory-confirmed COVID-19 or COVID-19–compatible symptoms and in contact with COVID-19 positive individual
Symptomatic health care workers with high-risk exposure but whose contact had PCR results pending were also included
Randomized 1:1 to the following
Oral hydroxychloroquine: 800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days
Masked placebo
Measurements
Symptoms and severity at baseline and then at days 3, 5, 10, and 14
Assessed using a 10-point visual analogue scale
Outcomes
The primary end point was changed to an overall symptom severity score over the course of 14 days
RESULTS:
423 contributed primary end point data (out of 491 randomized)
Median age: 40 years | 56% women | Identified as Black or African American were underrepresented (3%)
Enrolled within 1 day of onset of symptoms: 56% (236 of 423)
Change in symptom severity over 14 days did not differ between groups
Absolute difference in symptom severity: −0.27 points (95% CI, −0.61 to 0.07 points; P=0.117)
There was no difference in proportion of patients with ongoing symptoms at 14 days (P=0.21)
Hydroxychloroquine: 24%
Placebo: 30%
Medication adverse effects were more frequent with hydroxychloroquine (P < 0.001)
Hydroxychloroquine: 43%
Placebo: 22%
There was no significant difference in hospitalization or death (P = 0.29)
Hydroxychloroquine: 4 hospitalizations occurred | 1 nonhospitalized death
Placebo: 10 hospitalizations (2 non–COVID-19–related) | 1 hospitalized death
CONCLUSION:
The authors note that the population was relatively young, with few comorbid conditions and therefore these outcomes may not be generalizable to all population groups | A substantial proportion of patients were enrolled based on symptoms and not SARS-CoV-2 testing (due to limited availability)
The authors conclude that
Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19
Universal Masking and COVID-19 Infection Rates in Healthcare Personnel
PURPOSE:
Wang et al. (JAMA, 2020) assessed whether a program of universal masking in a large healthcare system was associated with the SARS-CoV-2 infection rate among healthcare personnel
METHODS:
Retrospective cohort study
Mass General Brigham (MGB) |12 hospitals 75 000 employees
Hospital system initiated a COVID-19 infection reduction strategy that included
Systematic SARS-CoV-2 testing of symptomatic healthcare personnel
Universal masking of all healthcare personnel and patients (surgical masks)
3 phases
Preintervention period before universal masking: March 1 to 24, 2020
Transition period until implementation of universal masking of patients: March 25 to April 5, 2020
Lag period to allow for manifestations of symptoms: April 6 to 10, 2020
Intervention period; April 11 to 30, 2020
Positivity rate
Numerator: First positive test result for all healthcare personnel
Denominator: Healthcare personnel who never tested positive plus those who tested positive that day
Statistical analysis
Mean trends calculated based on overall slope of each period was calculated using linear regression
Change in overall slope compared between the preintervention vs intervention periods
RESULTS:
9850 Healthcare Personnel underwent testing
Positive results: 12.9% | Median age, 39 years
73% female | 7.4% physicians or trainees | 26.5% nurses or PAs | 17.8% technologists or nursing support | 48.3% other
Preintervention period: SARS-CoV-2 positivity rate increased exponentially from 0% to 21.32% | Weighted mean increase of 1.16% per day | Case doubling time of 3.6 days (95% CI, 3.0 to 4.5 days)
Intervention period: SARS-CoV-2 positivity rate decreased linearly from 14.65% to 11.46% | Weighted mean decline of 0.49% per day
Net slope change: 1.65% more decline per day compared with the preintervention period (95% CI, 1.13% to 2.15%; P < .001)
CONCLUSION:
Universal masking was associated with a decrease in SARS-CoV-2 infection rates among healthcare personnel
The authors acknowledge the possibility of confounding due to other transmission prevention measures such as social distancing
The authors state that
Randomized trials of universal masking of HCWs during a pandemic are likely not feasible
Nonetheless, these results support universal masking as part of a multipronged infection reduction strategy in health care settings
Ferrazzi et al. (BJOG, 2020) report on the mode of delivery and immediate neonatal outcomes in women infected with COVID-19 in Lombardy, Italy
METHODS:
Retrospective study
Setting
12 hospitals in northern Italy
Participants
Confirmed COVID-19 prior to or within 36 hours after delivery
Delivered from March 1 to March 20, 2020
All consecutive cases admitted to maternity ward for delivery
Study design
Data derived from clinical records
General maternal characteristics | Medical or obstetric co-morbidity | Course of pregnancy | Clinical signs and symptoms | Treatment of COVID 19 infection | Mode of delivery | Neonatal data and breastfeeding
Primary outcome
Mode of delivery
Neonatal outcome
RESULTS:
Total 42 women with COVID-19
Mean maternal age: 32.9 years (range 21 to 44 years)
COVID-19 diagnosis
Known before admission: 19 cases
On hospital admission: 10 cases
Delivery room: 27 cases
Within 36 hours of delivery: 5 cases (patients still admitted)
Maternal clinical features
Most common symptoms: Fever, cough and mild dyspnoea (80%)
Two women breastfed without a mask because COVID-19 infection was diagnosed in the postpartum period
Their newborns tested positive for COVID-19 (days 1 and 3)
In one case, a newborn had a positive test after a vaginal operative delivery | Mother did not breastfeed
Symptoms day 3 | Recovered after 1 day of mechanical ventilation
CONCLUSION:
Authors acknowledge that vertical transmission risk with vaginal delivery cannot be excluded
However, results from this study would suggest that vaginal delivery is associated with a low risk of COVID-19 transmission
In addition, the author conclude that
Vaginal delivery is appropriate in mild cases and caesarean section should be reserved for women with severe respiratory problems, where delivering the baby will allow improved ventilation
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 CDC now includes a separate page on COVID-19 and pregnancy data (see ‘Learn More – Primary Sources’). The initial dataset is based on the MMWR review (June 26, 2020) and the page will be updates as new data becomes available
Summary of MMWR study
Methods
CDC receives reports of COVID-19 cases through
Electronic standardized case report form or The National Notifiable Diseases Surveillance System
Data updated by health departments
Case reports for this study: January 22 to June 7 and updated as of June 17, 2020
Participants
Women aged 15 to 44 years (reproductive age) from 50 states, the District of Columbia, and New York City
Lab confirmed SARS-CoV-2 infection
Data collected included
Demographics | Pregnancy status | Underlying medical conditions | Clinical course | Outcomes (maternal)
Missing data
To avoid overestimating the risk for adverse outcomes, “Outcomes with missing data were assumed not to have occurred (i.e., if data were missing on hospitalization, women were assumed to not have been hospitalized)”
Statistical analysis
Outcomes: Logistic regression, using crude and adjusted risk ratios and 95% CIs
Risk ratios (RR) adjusted for
Age | Presence of underlying chronic conditions | Race/ethnicity
Results
Women of reproductive age and positive for SARS-CoV-2: 326,335
Pregnancy status
28% (91,412) of all reproductive age women had pregnancy status available | Among those women with pregnancy information, 9% (8,207) were reported as pregnant
Symptoms
Cough: Similar between pregnant and nonpregnant women (>50%)
Shortness of breath: Similar between pregnant and non-pregnant (30%)
Pregnancy status was missing for approximately 75% of women of reproductive age
Data on race/ethnicity, symptoms, underlying conditions, and outcomes were missing “for a large proportion of cases”
Data not available for the following
Trimester at time of infection was not available
Whether hospitalization was related to COVID-19
Current routine case surveillance does not capture pregnancy or birth outcomes
CDC concludes that
These findings suggest that among women of reproductive age with COVID-19, pregnant women are more likely to be hospitalized and at increased risk for ICU admission and receipt of mechanical ventilation compared with nonpregnant women, but their risk for death is similar
The ‘Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial’ is a national program in the UK to study multiple potential therapies for SARS-CoV-2 infection. The program involves thousands of doctors, nurses, pharmacists, and research personnel. The dexamethasone branch of the RECOVERY Trial program was halted on June 8th because the steering committee felt there was sufficient evidence to make a determination whether there was benefit to this therapy. The chief investigators, Professors Horby and Landray, reported the findings on June 16, 2020.
The preliminary results found that
Overall dexamethasone reduced the 28-day mortality rate by 17% (0.83 [0.74 to 0.92]; P=0.0007) with a highly significant trend showing greatest benefit among those patients requiring ventilation (test for trend p<0.001)
Methods
Randomized controlled trial (RCT)
Participants
Patients hospitalized with COVID-19
Randomization
Dexamethasone 6 mg daily (oral or IV) vs usual care alone
Primary Outcomes
Within 28 days after randomization: Death | Discharge | Need for ventilation | Need for renal replacement therapy
Additional data collected
Age | Sex | Major co-morbidity | Pregnancy | COVID-19 onset date and severity
Results
Dexamethasone group: 2104 patients | Usual care alone: 4321 patients
Usual care group
28-day mortality rates
Requiring ventilation: 41%
Oxygen only: 25%
No respiratory intervention: 13%
Dexamethasone group: Reduction in deaths vs usual care alone
Requiring ventilation: Rate ratio (RR) 0.65 (95% CI, 0.48 to 0.88]; p=0.0003)
Oxygen only: RR 0.80 (95% CI, 0.67 to 0.96; p=0.0021)
No respiratory intervention: RR 1.22 (95% CI, 0.86 to 1.75; p=0.14)
Need to treat
Ventilated patients: 1 death would be prevented by treatment of approximately 8 patients
Oxygen alone: 1 death prevented by treatment of approximately 25 patients
KEY POINTS:
Reduction in deaths for hospitalized patients with COVID-19 with the use of low dose dexamethasone
Reduced deaths by one-third in ventilated patients
Reduced deaths by 20% for oxygen only patients
No benefit for patients not requiring respiratory support
Full report will be published
Professor Hornsby, one of the chief investigators states that
…dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide
FDA Revokes Hydroxychloroquine and Chloroquine EUA for the Treatment of COVID-19
SUMMARY:
The FDA has revoked the Emergency Use Authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate. Based on the available data, these medications do not appear to be effective in the treatment of COVID-19 and also present harms, specifically related to cardiac arrhythmias.
An EUA is different than a full FDA approval
EUA based on an FDA evaluation of evidence and risks vs potential or known benefits of “unproven” products during an emergency
Chloroquine phosphate and hydroxychloroquine sulfate, donated to the Strategic National Stockpile, received an EUA to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible
Based on benefits/harms analysis, these medications no longer meet the EUA requirements
KEY POINTS:
Research has demonstrated the following regarding hydroxychloroquine and chloroquine (see ‘Related ObG Entries’ below)
Hydroxychloroquine showed no benefit on mortality or in speeding recovery (RCT)
Suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19
“The totality of scientific evidence currently available indicate a lack of benefit”
FDA approved use of chloroquine and hydroxychloroquine
Still both FDA-approved to treat or prevent malaria
Hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis
Note: “FDA approved products may be prescribed by physicians for off-label uses if they determine it is appropriate for treating their patients, including during COVID”
Possible Drug Interaction with Remdesivir
The FDA also released a warning regarding a potential drug interaction between remdesivir and chloroquine and hydroxychloroquine
Data derived from a non-clinical laboratory study demonstrated possible reduction in the antiviral activity of remdesivir activity when co-administered with these medications
The FDA is not currently aware of reduced activity in the clinical setting and continues to evaluate data on this subject
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
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.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan
You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site
