This study will test a drug named remdesivir (GS-5734™) to evaluate the safety and effectiveness of the drug in treating patients with severe coronavirus disease 2019 (COVID-19).

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000841-15-DE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

1) Willing and able to provide written informed consent, or with a legal
representative who can provide informed consent, or enrolled under ICH
E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
investigator (participants = 18 years of age), or willing and able to
provide assent (participants = 12 and < 18 years of age, where locally
and nationally approved) prior to performing study procedures. For
participants = 12 and < 18 years of age, a parent or legal guardian
willing and able to provide written informed consent prior to performing
study procedures
2) Aged = 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 institutional review board [IRB] or
independent ethics committee [IEC])
3) SARS-CoV-2 infection confirmed by PCR = 4 days before
randomization
4) Currently hospitalized
5) SpO2 > 94% on room air or requiring supplemental oxygen at
screening
6) Radiographc evidence of pulmonary infiltrates
7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4250

Exclusion Criteria

1) Participation in any other clinical trial of an experimental treatment for COVID-19
2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
3) Evidence of multiorgan failure
4) Mechanically ventilated (including V-V ECMO) = 5 days, or any
duration of V-A ECMO.
5) ALT or AST > 5 x upper limit of normal (ULN)
6) Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula
for participants = 18 years of age {Cockcroft 1976} and Schwartz
Formula for participants < 18 years of age
7) Positive pregnancy test (Protocol; Appendix 3)
8) Breastfeeding woman
9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified