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Clinical Guidelines
5 October 2020

Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 1)FREE

Authors: Amir Qaseem, MD, PhD, MHA https://orcid.org/0000-0001-6866-7985, Jennifer Yost, RN, PhD https://orcid.org/0000-0002-3170-1956, Itziar Etxeandia-Ikobaltzeta, PharmD, PhD https://orcid.org/0000-0001-6606-649X, George M. Abraham, MD, MPH https://orcid.org/0000-0003-4296-8362, Janet A. Jokela, MD, MPH https://orcid.org/0000-0003-4324-4809, Mary Ann Forciea, MD https://orcid.org/0000-0002-1999-1145, Matthew C. Miller, MD https://orcid.org/0000-0001-7267-4897, and Linda L. Humphrey, MD, MPH for the Scientific Medical Policy Committee of the American College of Physicians Author, Article, & Disclosure Information
Publication: Annals of Internal Medicine
Volume 174, Number 2
https://doi.org/10.7326/M20-5831
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Key Question 1

What are the effectiveness and harms of remdesivir in patients with coronavirus disease 2019 (COVID-19)?

Key Question 2

Do effectiveness and harms vary by symptom duration, disease severity, and treatment duration?

Background

Remdesivir, a broad-spectrum antiviral agent administered intravenously, was developed and studied as a potential treatment for Ebola virus disease and Marburg virus infection (1–3). In vitro and in vivo preclinical studies found antiviral activity for remdesivir against corona-like viruses, including Middle East respiratory syndrome coronavirus (4–6), severe acute respiratory syndrome coronavirus (SARS-CoV-1) (5), the circulating human coronaviruses HCoV-OC42 and HCoV-229E (7), and SARS-CoV-2 (8). Currently, the effectiveness of remdesivir is being tested as a treatment for patients infected with SARS-CoV-2 (COVID-19) and has been authorized for emergency use for treating COVID-19, by the U.S. Food and Drug Administration (9) in the United States, and in other countries (10–13).
The American College of Physicians (ACP) Scientific Medical Policy Committee (SMPC) based these rapid and living practice points (Table 1) on a systematic evidence review conducted by the U.S. Department of Veterans Affairs (VA) Evidence Synthesis Program in Minneapolis, Minnesota (14) (Appendix). This version of the practice points, based on a search completed on 3 June 2020 and updated through 31 August 2020, was approved by the ACP's Executive Committee of Board of Regents on behalf of the Board of Regents on 14 August 2020 and submitted to Annals of Internal Medicine on 13 August 2020. Because many studies are planned or under way, literature surveillance is ongoing, with updates currently planned for every 2 months through December 2021. The target audience for these practice points includes clinicians and the public. The target patient population includes all nonpregnant patients with COVID-19.
Table 1. Practice Points
Table 1. Practice Points
Critical and important outcomes were determined by the evidence review team in collaboration with methodological and content experts. The magnitude of the effect (such as little or no, slight, modest, or large) for critical and important outcomes was determined by applying thresholds prespecified by the evidence review team (Table 2). Table 3 presents clinical considerations, the Figure and Tables 4 and 5 summarize current evidence, and Table 6 identifies additional evidence gaps. Appendix Tables 1 and 2 present the data estimates supporting the practice points.
Table 2. Thresholds for Determining Magnitude of Effect*
Table 2. Thresholds for Determining Magnitude of Effect*
Table 3. Clinical Considerations
Table 3. Clinical Considerations
Figure. Evidence description. The evidence search and assessment were conducted by the U.S. Department of Veterans Affairs Evidence Synthesis Program, Minneapolis, Minnesota (14). Current search for evidence, completed on 3 June 2020, aimed to identify RCTs evaluating remdesivir for treatment of patients with COVID-19. COVID-19 = coronavirus disease 2019; ECMO = extracorporeal membrane oxygenation; RCT = randomized controlled trial. * Patients requiring mechanical ventilation or ECMO were excluded from 1 RCT (17); therefore, despite a few patients (3.3%) developing a requirement for invasive mechanical ventilation between screening and the beginning of the treatment, this study is analyzed as being representative of patients with severe disease not requiring mechanical ventilation or ECMO at baseline. † Within the evidence reviewed, severe COVID-19 is defined as hospitalized patients meeting ≥1 of the following criteria: radiographic infiltrates on imaging, an oxygen saturation level ≤94% on room air, tachypnea (respiratory rate >24 breaths per minute without supplemental oxygen), or need for supplemental oxygen or mechanical ventilation; moderate COVID-19 is defined as hospitalized patients with radiographic infiltrates and oxygen saturation greater than 94% on room air; and mild COVID-19 was not defined (14). ‡ Most (88.7%) of the participants enrolled in 1 RCT (16) had severe disease, so this study is analyzed as being representative of patients with severe disease.
Figure. Evidence description.
The evidence search and assessment were conducted by the U.S. Department of Veterans Affairs Evidence Synthesis Program, Minneapolis, Minnesota (14). Current search for evidence, completed on 3 June 2020, aimed to identify RCTs evaluating remdesivir for treatment of patients with COVID-19. COVID-19 = coronavirus disease 2019; ECMO = extracorporeal membrane oxygenation; RCT = randomized controlled trial.
* Patients requiring mechanical ventilation or ECMO were excluded from 1 RCT (17); therefore, despite a few patients (3.3%) developing a requirement for invasive mechanical ventilation between screening and the beginning of the treatment, this study is analyzed as being representative of patients with severe disease not requiring mechanical ventilation or ECMO at baseline.
† Within the evidence reviewed, severe COVID-19 is defined as hospitalized patients meeting ≥1 of the following criteria: radiographic infiltrates on imaging, an oxygen saturation level ≤94% on room air, tachypnea (respiratory rate >24 breaths per minute without supplemental oxygen), or need for supplemental oxygen or mechanical ventilation; moderate COVID-19 is defined as hospitalized patients with radiographic infiltrates and oxygen saturation greater than 94% on room air; and mild COVID-19 was not defined (14).
‡ Most (88.7%) of the participants enrolled in 1 RCT (16) had severe disease, so this study is analyzed as being representative of patients with severe disease.
Table 4. Evidence Summary for Patients With Moderate* COVID-19: What Information Does the Evidence Provide?
Table 4. Evidence Summary for Patients With Moderate* COVID-19: What Information Does the Evidence Provide?
Table 5. Evidence Summary for Patients With Severe* COVID-19: What Information Does the Evidence Provide?
Table 5. Evidence Summary for Patients With Severe* COVID-19: What Information Does the Evidence Provide?
Table 6. Evidence Gaps
Table 6. Evidence Gaps
Appendix Table 1. Estimates: Patients With Moderate* COVID-19†
Appendix Table 1. Estimates: Patients With Moderate* COVID-19†
Appendix Table 2. Estimates: Patients With Severe* COVID-19†
Appendix Table 2. Estimates: Patients With Severe* COVID-19†

Rationale

Use of Remdesivir in Patients With Moderate COVID-19

Table 4 summarizes the current evidence on the use of remdesivir in patients with moderate COVID-19.
Overall, the current evidence points toward a net benefit for remdesivir in patients with moderate COVID-19 and suggests that a shorter treatment period (5 days) is as effective as a longer one (10 days), with no increase in harms (16). Low-certainty evidence shows that the 5-day course may be superior for mortality, recovery, and clinical improvement; however, low-certainty evidence also shows improvement for several outcomes when comparing the 10-day course to placebo. Thus, the SMPC believes that it is reasonable to consider extending treatment to 10 days for patients whose condition does not improve during the initial 5 days. Because the overall certainty of evidence is low across the comparisons, the SMPC has flagged course duration as a particular area of interest for further discussion and close monitoring.
Evidence from 1 randomized controlled trial (RCT) (16) compared a 5- or 10-day course of remdesivir with standard care, although “standard care” was not defined. Among outcomes rated as critical, remdesivir (5- or 10-day course) may reduce mortality slightly and result in slightly fewer serious adverse events compared with standard care (low certainty). Evidence also showed a modest increase in recovery and clinical improvement with a 5-day course, and slight increases in recovery and clinical improvement with a 10-day course, compared with standard care (low certainty). A 5-day course may also reduce time to recovery slightly (low certainty), but evidence is insufficient to make any conclusions about a 10-day course. Both courses of remdesivir (5- and 10-day) may slightly reduce the need for invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) (low certainty). However, the occurrence of any adverse events may increase with a 5-day course (slight effect) and with a 10-day course (modest effect) compared with standard care (low certainty).
Evidence comparing a 5- versus 10-day course of remdesivir (16) showed that a 5-day course may reduce mortality slightly and may increase recovery (modest effect) and clinical improvement (slight effect) compared with a 10-day course (low certainty). However, evidence showed little to no difference between the 2 courses in reducing the need for invasive mechanical ventilation or ECMO (low certainty), and evidence is insufficient to show a difference in time to recovery. Evidence for potential harms showed that a 5-day course may result in fewer adverse events (any) compared with a 10-day course (modest effect), although the shorter course may not result in fewer serious adverse events (low certainty).
No evidence was found for any effect on other critical outcomes (hospital length of stay) or important outcomes (time to clinical improvement, nonserious adverse events) with either course in patients with moderate COVID-19. No evidence was identified as to whether outcomes vary by symptom duration in patients with moderate COVID-19.

Use of Remdesivir in Patients With Severe COVID-19

Table 5 summarizes the current evidence on the use of remdesivir in patients with severe COVID-19 (15, 17, 18).
Overall, the current evidence points toward a net benefit for a 10-day course of remdesivir in patients with severe COVID-19 (including those requiring mechanical ventilation or ECMO at baseline) compared with placebo (15, 18). No evidence was found comparing a 5-day course of remdesivir with placebo or standard care in patients with severe COVID-19. In the absence of this direct evidence, the SMPC looked at the indirect evidence that a 5-day course is as effective as a 10-day course of remdesivir with the same, or probably fewer, potential harms in patients with severe COVID-19 not requiring mechanical ventilation or ECMO at baseline (17). In addition, the compliance data showed that a 10-day course (10 doses) was used in 40.8% of patients with severe COVID-19 (including those requiring mechanical ventilation or ECMO at baseline), and 38.1% received fewer than 10 doses because they recovered and were discharged from the hospital (15). However, for a subgroup of patients with severe COVID-19 receiving mechanical ventilation or ECMO at day 5, extending treatment to 10 days may be beneficial compared with discontinuing treatment on day 5 (17).
Evidence from 2 RCTs (15, 18) showed that among outcomes rated as critical, a 10-day course of remdesivir compared with placebo may slightly reduce mortality (low certainty) and probably increases recovery by a large effect (moderate certainty), and that there are probably fewer serious adverse events (modest effect, moderate certainty). Evidence from 1 RCT showed that a 10-day course may not reduce hospital length of stay (low certainty) (18). Low-certainty evidence also showed improvement with a 10-day course compared with placebo for the following important outcomes: time to recovery (large effect), clinical improvement (modest effect), time to clinical improvement (slight effect), the need for mechanical ventilation or ECMO (slight effect), and nonserious adverse events (slight effect). Evidence was insufficient regarding differences in any adverse events.
For a 10-day course of remdesivir compared with placebo, the outcomes of mortality (18), time to recovery (15), and time to clinical improvement (18) did not vary by symptom duration (≤10 days vs. >10 days), and time to recovery also did not vary by baseline oxygenation or ventilation requirements (15). No evidence was found on whether other outcomes vary by symptom duration.
Evidence from 1 RCT (17) that compared a 5-day course with a 10-day course of remdesivir showed that the 5-day course may reduce mortality slightly versus the 10-day course in patients with severe COVID-19 who did not require mechanical ventilation or ECMO at baseline (17). However, a post hoc analysis suggested that a 5- versus a 10-day course might result in a large increase in mortality among the most critical patients of those with severe COVID-19 (those receiving mechanical ventilation or ECMO at day 5) (17). Treatment beyond 5 days did not improve mortality among patients who were receiving noninvasive positive pressure ventilation or high-flow oxygen, those receiving low-flow oxygen, or those breathing ambient air. This finding suggests that extending treatment to 10 days for patients receiving mechanical ventilation or ECMO at day 5 may be beneficial (17). Compared with a 10-day course, a 5-day course shows a modest increase in recovery, a slight decrease in the time to recovery, and a modest reduction in the need for mechanical ventilation or ECMO (low certainty). Evidence for potential harms showed that a 5-day course of remdesivir results in fewer serious adverse events (large effect, low certainty) and a fewer number of any adverse events (slight effect, low certainty) compared with a 10-day course.

Appendix: Practice Points Development Process

The SMPC, in collaboration with staff from ACP's Department of Clinical Policy, developed these practice points on the basis of a rapid and living systematic evidence review conducted by the VA Evidence Synthesis Program, Minneapolis, Minnesota (14). The SMPC comprises 11 internal medicine physicians representing various clinical areas of expertise and 1 public (nonclinician) member, and includes members with expertise in epidemiology, evidence synthesis, health policy, and guideline development. In addition to contributing clinical, scientific, and methodological expertise, Clinical Policy staff provided administrative support and liaised among the SMPC, the evidence review funding entity and evidence team, and the journal. Clinical Policy staff and the SMPC reviewed and prioritized potential topic suggestions from ACP members, SMPC members, and ACP governance. A committee subgroup, including the SMPC chair, worked with staff to draft the key questions and led the development of the practice points. Clinical Policy staff worked with the subgroup and an independent evidence review team to refine the key questions and determine appropriate evidence synthesis methods for each key question. Via conference calls and e-mail, Clinical Policy staff worked with the committee subgroup to draft the practice points on the basis of the results of the rapid and living systematic evidence review. The full SMPC reviewed and approved the final practice points. Before journal submission, ACP's Executive Committee of the Board of Regents also reviewed and approved the practice points on behalf of the ACP Board of Regents. The evidence review team will continually update the evidence review. The ACP will update the practice points based on the evidence review by using the same process as the first version described above. Updates are currently planned for every 2 months through December 2021. The SMPC will continuously assess the priority of the topic and the overall state of evidence, including the anticipated rate of new evidence, and may choose to modify the update intervals accordingly (any modifications will be described in an Update Alert).

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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 174 • Number 2 • February 2021
Pages: 229 - 236

History

Published online: 5 October 2020
Published in issue: February 2021

Keywords

  1. Adverse events
  2. COVID-19
  3. Extracorporeal membrane oxygenation
  4. Mortality
  5. Oxygen
  6. Patient advocacy
  7. Patients
  8. Systematic reviews
  9. Ventilators

Copyright

© 2020 American College of Physicians.

Authors

Affiliations

Amir Qaseem, MD, PhD, MHA https://orcid.org/0000-0001-6866-7985
American College of Physicians, Philadelphia, Pennsylvania (A.Q., I.E.)
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Jennifer Yost, RN, PhD https://orcid.org/0000-0002-3170-1956
American College of Physicians, Philadelphia, and Villanova University, Villanova, Pennsylvania (J.Y.)
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Itziar Etxeandia-Ikobaltzeta, PharmD, PhD https://orcid.org/0000-0001-6606-649X
American College of Physicians, Philadelphia, Pennsylvania (A.Q., I.E.)
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George M. Abraham, MD, MPH https://orcid.org/0000-0003-4296-8362
University of Massachusetts Medical School and Saint Vincent Hospital, Worcester, Massachusetts (G.M.A.)
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Janet A. Jokela, MD, MPH https://orcid.org/0000-0003-4324-4809
University of Illinois College of Medicine at Urbana-Champaign, Champaign, Illinois (J.A.J.)
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Mary Ann Forciea, MD https://orcid.org/0000-0002-1999-1145
Penn Medicine, Philadelphia, Pennsylvania (M.A.F., M.C.M.)
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Matthew C. Miller, MD https://orcid.org/0000-0001-7267-4897
Penn Medicine, Philadelphia, Pennsylvania (M.A.F., M.C.M.)
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Linda L. Humphrey, MD, MPH
Portland Veterans Affairs Medical Center and Oregon Health & Science University, Portland, Oregon (L.L.H.)
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for the Scientific Medical Policy Committee of the American College of Physicians
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Note: The Practice Points are developed by the SMPC of the ACP. The Practice Points are “guides” only and may not apply to all patients and all clinical situations. All Practice Points are considered automatically withdrawn or invalid 5 years after publication, or once an update has been issued.
Financial Statement: Financial support for the development of the Practice Points comes exclusively from the ACP operating budget.
Disclosures: All financial and intellectual disclosures of interest were declared and potential conflicts were discussed and managed. Dr. Obley participated in discussion of the practice points but was recused from authorship and voting due to a moderate-level conflict of interest (author of supporting systematic review). A record of disclosures of interest and management of conflicts of is kept for each SMPC meeting and conference call and can be viewed at https://www.acponline.org/about-acp/who-we-are/leadership/boards-committees-councils/scientific-medical-policy-committee/disclosure-of-interests-and-conflict-of-interest-management-summary-for-scientific-medical-policy. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-5831.
Corresponding Author: Amir Qaseem, MD, PhD, MHA, American College of Physicians, 190 N. Independence Mall West, Philadelphia, PA 19106; e-mail, [email protected].
Current Author Addresses: Dr. Qaseem: American College of Physicians, 190 N Independence Mall West, Philadelphia, PA 19106.
Dr. Yost: 800 Lancaster Avenue, Villanova, PA 19085.
Dr. Etxeandia-Ikobaltzeta: 1, Santa Margarita Hospital Street, Ground Floor 2, Office 1, Room 2, 20303 Irun, Gipuzkoa, Spain.
Dr. Abraham: 123 Summer Street, Suite 370, North Worcester, MA 01608.
Dr. Jokela: Carle Forum, 611 West Park, Urbana, IL 61801.
Dr. Forciea: 3615 Chestnut Street, Philadelphia, PA 19104.
Dr. Miller: Penn Medicine Radnor, 145 King of Prussia Road, Radnor, PA 19087.
Dr. Humphrey: 12310 Northwest Tualatin Avenue, Portland, OR 97229.
Author Contributions: Conception and design: A. Qaseem, J. Yost, I. Etxeandia-Ikobaltzeta, M.A. Forciea, R. Haeme, D.L. Kansagara, M. Marcucci, A. Obley.
Analysis and interpretation of the data: A. Qaseem, J. Yost, I. Etxeandia-Ikobaltzeta, J.A. Jokela, M.A. Forciea, L.L. Humphrey, R. Haeme, A.J. Obley.
Drafting of the article: A. Qaseem, J. Yost, I. Etxeandia-Ikobaltzeta, G.M. Abraham, R. Haeme, D.L. Kansagara.
Critical revision for important intellectual content: A. Qaseem, J. Yost, I. Etxeandia-Ikobaltzeta, G.M. Abraham, J.A. Jokela, M.A. Forciea, M.C. Miller, L.L. Humphrey, E.A. Akl, R. Andrews, R.M. Centor, R. Haeme, D.L. Kansagara, M. Marcucci, A.J. Obley.
Final approval of the article: A. Qaseem, J. Yost, I. Etxeandia-Ikobaltzeta, G.M. Abraham, J.A. Jokela, M.A. Forciea, M.C. Miller, L.L. Humphrey, E.A. Akl, R. Andrews, T.A. Bledsoe, R.M. Centor, R. Haeme, D.L. Kansagara, M. Marcucci.
Provision of study materials or patients: I. Etxeandia-Ikobaltzeta.
Statistical expertise: A. Qaseem, I. Etxeandia-Ikobaltzeta.
Administrative, technical, or logistic support: A. Qaseem, J. Yost.
Collection and assembly of data: J. Yost, I. Etxeandia-Ikobaltzeta.
This article was published at Annals.org on 5 October 2020.
* This paper, written by Amir Qaseem, MD, PhD, MHA; Jennifer Yost, RN, PhD; Itziar Etxeandia-Ikobaltzeta, PharmD, PhD; George M. Abraham, MD, MPH; Janet A. Jokela, MD, MPH; Mary Ann Forciea, MD; Matthew C. Miller, MD; and Linda L. Humphrey, MD, MPH, was developed for the Scientific Medical Policy Committee of the American College of Physicians. Individuals who served on the Scientific Medical Policy Committee from initiation of the project until its approval were Linda L. Humphrey, MD, MPH (Chair)†; Robert M. Centor, MD (Vice Chair)†; Elie A. Akl, MD, MPH, PhD‡; Rebecca Andrews MS, MD†; Thomas A. Bledsoe, MD‡; Mary Ann Forciea, MD†; Ray Haeme†§; Janet A. Jokela, MD, MPH†; Devan L. Kansagara, MD, MCR†; Maura Marcucci, MD, MSc†; Matthew C. Miller, MD†; and Adam Jacob Obley, MD‡. Approved by the ACP Executive Committee of the Board of Regents on Behalf of the Board of Regents on 14 August 2020.
† Author (participated in discussion and voting).
‡ Nonauthor contributor (participated in discussion but excluded from voting).
§ Nonphysician public representative.
Update Alerts: The authors have specified in the Background section and the Appendix the interval and stop date for updates to this Practice Points article. As Annals receives updates, they will appear in the Comments section of the article on Annals.org. Reader inquiries about updates that are not available at approximately the specified intervals should be submitted as comments to the article.

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Amir Qaseem, Jennifer Yost, Itziar Etxeandia-Ikobaltzeta, et al; for the Scientific Medical Policy Committee of the American College of Physicians . Should Remdesivir Be Used for the Treatment of Patients With COVID-19? Rapid, Living Practice Points From the American College of Physicians (Version 1). Ann Intern Med.2021;174:229-236. [Epub 5 October 2020]. doi:10.7326/M20-5831

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