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NCT04292899

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Completed Phase 3 Results posted Last updated 31 December 2020
What this trial tests

Phase 3 trial testing Remdesivir in COVID-19 in 4,891 participants. Completed in 30 June 2020.

Timeline
6 March 2020
Primary endpoint
9 April 2020
30 June 2020

Quick facts

Lead sponsorGilead Sciences
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment4,891
Start date6 March 2020
Primary completion9 April 2020
Estimated completion30 June 2020
Sites183 locations across France, Hong Kong, Italy, Japan, Netherlands, Sweden, Taiwan, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Gilead Sciences — full company profile →

Who can join

12 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 14 Primary · Day 14

Clinical status was derived from death, hospital discharge, and the ordinal scale as follows: score of "1" was used for all days on or after the date of death; score of "7" was used for all days on or after discharged alive date; last assessment carried forward for any missing values.The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COV

Score: 1
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days8.0
Part A: Remdesivir for 10 Days10.7
Score: 2
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days8.5
Part A: Remdesivir for 10 Days16.8
Score: 3
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days4.0
Part A: Remdesivir for 10 Days5.1
Score: 4
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days9.5
Part A: Remdesivir for 10 Days7.6
Score: 5
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days6.0
Part A: Remdesivir for 10 Days6.1
Score: 6
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days4.0
Part A: Remdesivir for 10 Days1.5
Score: 7
GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days60.0
Part A: Remdesivir for 10 Days52.3
Part A: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) Secondary · First dose date up to last dose date (maximum: 10 days) plus 30 days

Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study treatment start date and no later than 30 days after the permanent discontinuation of the study treatment and/or the AEs that led to premature discontinuation of study treatment.

GroupValue95% CI
Part A: Remdesivir (RDV) for 5 Days71.564.7 – 77.6
Part A: Remdesivir for 10 Days75.168.5 – 81.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Part A: First dose date up to the last dose date (maximum: 10 days) plus 30 days; Part B: First dose date up to the last dose date (maximum: 11 days) plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: Remdesivir (RDV) for 5 Days
Serious: 43/200 (22%)
Deaths: 25/200
Part A: Remdesivir for 10 Days
Serious: 68/197 (35%)
Deaths: 28/197
Part B: Remdesivir for 10 Days (Mechanically Ventilated Group)
Serious: 362/844 (43%)
Deaths: 213/844
Part B: Remdesivir for 10 Days (Extension Group)
Serious: 851/3597 (24%)
Deaths: 422/3597

Serious adverse events (275 terms)

ReactionSystemPart A: Remdesivir (RDV) f…Part A: Remdesivir for 10 …Part B: Remdesivir for 10 …Part B: Remdesivir for 10 …
Respiratory failureRespiratory, thoracic and mediastinal disorders
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
Respiratory distressRespiratory, thoracic and mediastinal disorders
Acute kidney injuryRenal and urinary disorders
HypotensionVascular disorders
Septic shockInfections and infestations
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders
Cardiac arrestCardiac disorders
SepsisInfections and infestations
Multiple organ dysfunction syndromeGeneral disorders
Pulmonary embolismRespiratory, thoracic and mediastinal disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
PneumothoraxRespiratory, thoracic and mediastinal disorders
PneumoniaInfections and infestations
Corona virus infectionInfections and infestations
Pneumonia viralInfections and infestations
Respiratory disorderRespiratory, thoracic and mediastinal disorders
Renal failureRenal and urinary disorders
Atrial fibrillationCardiac disorders
Cardio-respiratory arrestCardiac disorders
ShockVascular disorders
Mental status changesPsychiatric disorders
AnaemiaBlood and lymphatic system disorders
BacteraemiaInfections and infestations
Other adverse events (20 terms — click to expand)

ReactionSystemPart A: Remdesivir (RDV) f…Part A: Remdesivir for 10 …Part B: Remdesivir for 10 …Part B: Remdesivir for 10 …
ConstipationGastrointestinal disorders
NauseaGastrointestinal disorders
HypokalaemiaMetabolism and nutrition disorders
HypotensionVascular disorders
Alanine aminotransferase increasedInvestigations
DiarrhoeaGastrointestinal disorders
Aspartate aminotransferase increasedInvestigations
Acute kidney injuryRenal and urinary disorders
InsomniaPsychiatric disorders
AnaemiaBlood and lymphatic system disorders
PyrexiaGeneral disorders
Transaminases increasedInvestigations
HyperglycaemiaMetabolism and nutrition disorders
HypernatraemiaMetabolism and nutrition disorders
HypertensionVascular disorders
AgitationPsychiatric disorders
DeliriumPsychiatric disorders
Deep vein thrombosisVascular disorders
PneumoniaInfections and infestations
LeukocytosisBlood and lymphatic system disorders

Most-reported serious reactions: Respiratory failure, Acute respiratory failure, Hypoxia, Respiratory distress, Acute kidney injury, Hypotension, Septic shock, Acute respiratory distress syndrome.

Data from ClinicalTrials.gov NCT04292899 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

Publications & conference data

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

  1. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study.
    Cummings MJ, Baldwin MR, Abrams D, Jacobson SD, et al · · 2020 · cited 1603× · PMID 32442528 · DOI 10.1016/s0140-6736(20)31189-2
  2. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
    Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
  3. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.
    Goldman JD, Lye DCB, Hui DS, Marks KM, et al · · 2020 · cited 1009× · PMID 32459919 · DOI 10.1056/nejmoa2015301
  4. Remdesivir: A Review of Its Discovery and Development Leading to Emergency Use Authorization for Treatment of COVID-19.
    Eastman RT, Roth JS, Brimacombe KR, Simeonov A, et al · · 2020 · cited 595× · PMID 32483554 · DOI 10.1021/acscentsci.0c00489
  5. The epidemiology, diagnosis and treatment of COVID-19.
    Zhai P, Ding Y, Wu X, Long J, et al · · 2020 · cited 461× · PMID 32234468 · DOI 10.1016/j.ijantimicag.2020.105955
  6. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
    Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
  7. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19.
    Klok FA, Boon GJAM, Barco S, Endres M, et al · · 2020 · cited 427× · PMID 32398306 · DOI 10.1183/13993003.01494-2020
  8. Drug repurposing approach to fight COVID-19.
    Singh TU, Parida S, Lingaraju MC, Kesavan M, et al · · 2020 · cited 299× · PMID 32889701 · DOI 10.1007/s43440-020-00155-6

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