COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04501952

Gilead Clinical Study Information Center

GileadClinicalTrials@gilead.com

2020-08-06

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

key inclusion criteria: willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (irb) or independent ethics committee (iec). for individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures either: age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant irb or iec with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease) or aged ≥ 60 years severe acute respiratory syndrome (sars)-coronavirus (cov)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (pcr) or antigen testing) ≤ 4 days prior to screening presence of ≥ 1 symptom(s) consistent with covid-19 for ≤ 7 days prior to randomization not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care) key

- participation in any other clinical trial of an experimental treatment and prevention for covid-19 - prior hospitalization for covid-19 - treatment with other agents with actual or possible direct antiviral activity against sars-cov-2 or administration of any sars-cov-2 (or covid-19) vaccine - requiring oxygen supplementation note: other protocol defined inclusion/exclusion criteria may apply.

2

Gilead Sciences

12

100

Denmark;Spain;United Kingdom;United States

Mild disease at enrollment

1: Mild disease at enrollment

584

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs);Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28

None

Phase 3

[{"arm_notes": "Results also available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003510-12/results", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003510-12/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]