Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Sars-cov2
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Age: Between 12 - 120 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants who are 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
- Age =18 years or aged =12 and <18 years of age weighing =40 kg
- Participants hospitalized with confirmed SARS-CoV-2 by PCR or known contact of confirmed case with syndrome consistent with COVID-19 with PCR pending
- Participants requiring invasive mechanical ventilation
- ALT=5 × upper limit of normal (ULN) by local laboratory measure
You may not be eligible for this study if the following are true:
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- Participants with evidence of multiorgan failure including but not limited to coagulopathy, hepatic failure or renal failure, or significant cardiomyopathy
- Participants who use more than 1 pressor for septic shock
- Participants who has renal failure or dialysis or continuous Veno-Venous Hemofiltration
- Participants eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted
- Participants with known hypersensitivity to the study drug, the metabolites, or formulation excipient
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.