Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to \< 18, where locally and nationally approved) prior to performing study procedures
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))
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
Currently hospitalized
Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening
You may not be if
Participation in any other clinical trial of an experimental treatment for COVID-19
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
Evidence of multiorgan failure
Mechanically ventilated \[including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)\] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
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
Clareo Health | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)
