Clinical Trials

Inclusion Criteria:

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (e.g., Nucleic Acid Amplification Test [NAAT] and antigen tests) in any respiratory specimen.
• Hospitalized for COVID-19.
• Age ≥ 12 years and weighing at least 40 kg.
• Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19.
• Have either:
  • Severely reduced kidney function (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m^2 ), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and revised Schwartz equations for adults and adolescents, respectively, including people with ESKD requiring chronic dialysis but not people requiring RRT for AKI;
  • Adults: eGFR (mL/min/1.73 m²) 141 × min(SCr/κ, 1)α × max(SCr/κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if African American]
  • κ = 0.7 for females; 0.9 for males α = -0.329 for females; -0.411 for males
  • Adolescents (age 12–17 years): eGFR (mL/min/1.73 m²) = (0.41 × Height in cm) / SCr
  • SCr in mg/dL, age in years;
  • Ongoing AKI: defined as a 50% increase in SCr within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care.
• 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 (age ≥ 18) prior to performing study procedures.
• The interval between COVID-19 symptoms onset and randomization is no more than 10 days.
• Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Exclusion Criteria:

• Received any investigational drug, RDV, or other antiviral treatment for COVID-19.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal.
• Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for acute kidney injury (AKI).
• Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding.
• Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD).

Eligibility last updated 11/9/21. Questions regarding updates should be directed to the study team contact.