A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate COVID-19 compared to standard of care treatment

Gilead Sciences (United States)0 个研究点目标入组 1,113 人开始时间: 2020年11月3日最近更新: 2023年1月9日

适应症

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32821939/ (added 25/03/2021)

•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 test =4 days before randomization
•4. Currently hospitalized and requiring medical care for COVID-19
•5. SpO2 >94% on room air at screening
•6. Radiographic 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

•1. Participation in any other clinical trial of an experimental treatment for COVID-19
•2. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2
•3. Requiring mechanical ventilation at screening
•4. ALT or AST >5 x ULN
•Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone
•5. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants =18 years of age and Schwartz Formula for participants <18 years of age
•6. Positive pregnancy test
•7. Breastfeeding woman
•8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient

发起方

Gilead Sciences (United States)