NCT04257656

Brief Summary

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 ready 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 severe COVID-19.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

January 31, 2020

Last Update Submit

April 13, 2020

Conditions

COVID-19RemdesivirSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Time to Clinical Improvement (TTCI) [Censored at Day 28]

    The primary endpoint is time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment (remdesivir or placebo) until a decline of two categories on a six-category ordinal scale of clinical status (1 ꞊ discharged; 6 ꞊ death) or live discharge from hospital. Six-category ordinal scale: 6\. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1\. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. fever, respiratory rate, oxygen saturation return to normal, and cough relief). Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.

    up to 28 days

Secondary Outcomes (10)

  • Clinical status

    days 7, 14, 21, and 28

  • Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.

    up to 28 days

  • All cause mortality

    up to 28 days

  • Duration (days) of mechanical ventilation

    up to 28 days

  • Duration (days) of extracorporeal membrane oxygenation

    up to 28 days

  • +5 more secondary outcomes

Study Arms (2)

Remdesivir group

EXPERIMENTAL

active remdesivir

Drug: Remdesivir

Control group

PLACEBO COMPARATOR

Placebos matched remdesivir

Drug: Remdesivir placebo

Interventions

RemdesivirDRUG

RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.

Also known as: GS-5734
Remdesivir group
Remdesivir placeboDRUG

RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years at time of signing Informed Consent Form
  • Laboratory (RT-PCR) confirmed COVID-19.
  • Lung involvement confirmed with chest imaging
  • Hospitalized with a SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio \<300mgHg
  • ≤12 days since illness onset
  • Willingness of study participant to accept randomization to any assigned treatment arm.
  • Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study.

You may not qualify if:

  • Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
  • Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
  • Pregnant or breastfeeding, or positive pregnancy test in a predose examination
  • Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
  • Will be transferred to another hospital which is not the study site within 72 hours.
  • Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bin Cao

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (4)

  • Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

    PMID: 36695483DERIVED

  • Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.

    PMID: 34350582DERIVED

  • Wang Y, Zhou F, Zhang D, Zhao J, Du R, Hu Y, Cheng Z, Gao L, Jin Y, Luo G, Fu S, Lu Q, Du G, Wang K, Lu Y, Fan G, Zhang Y, Liu Y, Ruan S, Liu W, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. Trials. 2020 May 24;21(1):422. doi: 10.1186/s13063-020-04352-9.

    PMID: 32448345DERIVED

  • Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y, Luo G, Wang K, Lu Y, Li H, Wang S, Ruan S, Yang C, Mei C, Wang Y, Ding D, Wu F, Tang X, Ye X, Ye Y, Liu B, Yang J, Yin W, Wang A, Fan G, Zhou F, Liu Z, Gu X, Xu J, Shang L, Zhang Y, Cao L, Guo T, Wan Y, Qin H, Jiang Y, Jaki T, Hayden FG, Horby PW, Cao B, Wang C. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 16;395(10236):1569-1578. doi: 10.1016/S0140-6736(20)31022-9. Epub 2020 Apr 29.

    PMID: 32423584DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

February 6, 2020

Primary Completion

March 30, 2020

Study Completion

April 10, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

CN(1)