NCT04252664

A Trial of Remdesivir in Adults With Mild and Moderate COVID-19

Suspended Phase 3 Last updated 15 April 2020

What this trial tests

Phase 3 trial testing Remdesivir in COVID-19 in 308 participants. Suspended.

Timeline

12 February 2020

Primary endpoint
10 April 2020

27 April 2020

Quick facts

Lead sponsor	Capital Medical University
Phase	Phase 3
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	308
Start date	12 February 2020
Primary completion	10 April 2020
Estimated completion	27 April 2020
Sites	1 location across China

Drugs / interventions tested

• Remdesivir (remdesivir) — full drug profile →
• Remdesivir placebo — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• SARS-CoV-2 — all drugs for SARS-CoV-2 →

Sponsor

Capital Medical University

Who can join

18 and older, any sex, with COVID-19 or SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.

Given no specific antiviral therapy for COVID-19 and the availability of remdesvir as a potential antiviral agent based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with mild or moderate COVID-19.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study.
   Zhou F, Yu T, Du R, Fan G, et al · · 2020 · cited 18189× · PMID 32171076 · DOI 10.1016/s0140-6736(20)30566-3
2. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study.
   Yang X, Yu Y, Xu J, Shu H, et al · · 2020 · cited 6683× · PMID 32105632 · DOI 10.1016/s2213-2600(20)30079-5
3. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19).
   Alhazzani W, Møller MH, Arabi YM, Loeb M, et al · · 2020 · cited 1294× · PMID 32222812 · DOI 10.1007/s00134-020-06022-5
4. SARS-CoV-2 Vaccines: Status Report.
   Amanat F, Krammer F. · · 2020 · cited 808× · PMID 32259480 · DOI 10.1016/j.immuni.2020.03.007
5. Clinical and virological data of the first cases of COVID-19 in Europe: a case series.
   Lescure FX, Bouadma L, Nguyen D, Parisey M, et al · · 2020 · cited 784× · PMID 32224310 · DOI 10.1016/s1473-3099(20)30200-0
6. SARS-CoV-2 infection: The role of cytokines in COVID-19 disease.
   Costela-Ruiz VJ, Illescas-Montes R, Puerta-Puerta JM, Ruiz C, et al · · 2020 · cited 780× · PMID 32513566 · DOI 10.1016/j.cytogfr.2020.06.001
7. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy.
   Dashraath P, Wong JLJ, Lim MXK, Lim LM, et al · · 2020 · cited 647× · PMID 32217113 · DOI 10.1016/j.ajog.2020.03.021
8. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19).
   Alhazzani W, Møller MH, Arabi YM, Loeb M, et al · · 2020 · cited 599× · PMID 32224769 · DOI 10.1097/ccm.0000000000004363