• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • 0 CME Hours
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • #GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
COVID-19 Management

ACTT-1 Remdesivir RCT: Preliminary Results Now Published

image_pdfFavoriteLoadingFavorite

PURPOSE:

  • Beigel et al. sought to compare the efficacy of remdesivir vs placebo for the treatment of COVID-19
  • The following is the preliminary report from this multi-centered randomized controlled trial (RCT)

METHODS:

  • Multi-centered double-blind randomized placebo-controlled trial (Enrollment in effect between February 21, 2020, and April 19, 2020)
    • Adaptive Covid-19 Treatment Trial (ACTT-1)
    • Multiple sites including US (45 sites), Denmark (8), UK (5), Greece (4), Germany (3), Korea (2), Mexico (2), Spain (2), Japan (1), and Singapore (1)
  • Patients were randomized (1:1) into 2 groups, stratified by study site and disease severity
    • Remdesivir: IV 200-mg loading dose on day 1 | 100-mg maintenance dose daily on days 2 to 10 or until hospital discharge or death
    • Placebo: Administered using the same schedule and volume
  • Standard of care supportive care provided to all patients (based on local hospital protocols) | Addidtional experimental treatment or off-label use were not allowed from day 1 through day 29 (although prior use would not exclude a patient from this trial)
  • Primary outcome: Time to recovery, which meant either
    • Discharge from hospital or
    • Patient remained in hospital for infection-control purposes only, but could have otherwise been discharged

RESULTS:

  • On April 27, 2020, the data was reviewed by the safety monitoring board
  • This interim analysis occurred after enrollment completed (patient enrolled more rapidly than initially anticipated)
    • The data and safety monitoring board recommended that the data be opened up to the trial team members from the National Institute of Allergy and Infectious Diseases (NIAID) due to positive preliminary findings related to improved time to recovery
  • The results were then made public and treating physicians could request to unblind the treatment assignment if patient status worsening (see ‘Related ObG Topic’ below)
    • Patients in placebo group could be given remdesivir

Preliminary Results

  • 1059 patients were randomized
    • Remdesivir: 538
    • Placebo: 521
    • Majority of patients were enrolled in North America 79.8%
  • Median recovery time was faster for patients who received remdesivir
    • Remdesivir: 11 days (95% CI, 9 to 12)
    • Placebo: 15 days (95% CI, 13 to 19)
    • Rate ratio for recovery: 1.32; 95% CI, 1.12 to 1.55; P<0.001)
  • Mortality rates (by 14 days) were lower in the remdesivir group, although not statistically significant
    • Remdesivir: 7.1%
    • Placebo: 11.9%
    • Hazard ratio for death: 0.70 (95% CI, 0.47 to 1.04)
  • Serious adverse events
    • Remdesivir: 21.1%
    • Placebo: 27%

CONCLUSION:

  • The study is ongoing and more results will be available following 28 days of follow-up
  • However, these preliminary results indicate that remdesivir (10 day course) is superior to placebo for patients with COVID-19
  • Furthermore, the authors state that

These preliminary findings support the use of remdesivir for patients who are hospitalized with Covid-19 and require supplemental oxygen therapy. However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient

Learn More – Primary Sources:

Remdesivir for the Treatment of Covid-19 — Preliminary Report

Get COVID-19 Research Summaries Direct to Your Phone, with ObGFirst

Try it Free »

image_pdfFavoriteLoadingFavorite
< Previous
All COVID-19 Management Posts
Next >

Related ObG Topics:

Remdesivir Emergency Authorization: FDA Update and Summary of Preliminary NIH Study Data
Remdesivir for COVID-19: RCT Results from 10 Hospitals in China
ARDS, Critical Care and COVID-19: ‘Surviving Sepsis Campaign’ Guidelines and Key Points

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • #Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

ObG Library

  • Hysteroscopy
  • Fertility
  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Get Guideline Alerts Direct to Your Phone
Try ObGFirst Free!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

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

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

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