ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
- Signed informed consent.
- Requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes).
- Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure).
- SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization.
- Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.
- Known allergy to investigational agent or vehicle.
- More than 4 days since initiation of support for respiratory failure.
- Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
- Moribund patient (i.e. not expected to survive 24 hours).
- Active use of "comfort care" or other hospice-equivalent standard of care.
- Expected inability to participate in study procedures.
- In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments.
- Previous enrollment in TESICO
Agent-specific exclusion criteria
- Prior receipt of any dose of remdesivir during present illness (remdesivir agent).
- GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent).
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent).
- Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent).
- Refractory hypotension (aviptadil agent).
- Severe diarrhea (Aviptadil agent).
- Current C. difficile infection (aviptadil agent).
- Pregnancy or current breast-feeding (aviptadil agent).
- End-stage liver disease (aviptadil agent).