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).
- Conditions
- Coronavirus disease 2019 (COVID-19)MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-000841-15-GB
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6000
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 or 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
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 < 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
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14;Secondary Objective: To evaluate the safety and tolerability of RDV;Primary end point(s): Clinical status assessed by a 7-point ordinal scale on Day 14;Timepoint(s) of evaluation of this end point: Day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The proportion of participants with treatment emergent adverse events;Timepoint(s) of evaluation of this end point: From initiation of study medication until Day 14