Phase 3
Completed N=473
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Source: ClinicalTrials.gov NCT04843761 ↗Enrolled (actual)
473
Serious AEs
—
Results posted
Oct 2025
Primary outcomePrimary: Substudy Analysis Cohorts — 18; 21; 25; 21 Participants
◆ Published Evidence
Highly cited
110citations · ~37 / year
Remdesivir for the treatment of COVID-19.
Summary
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.
Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606)
Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)
Linked Publications (3)
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Remdesivir for the treatment of COVID-19.
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Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial.
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Estimation of the odds ratio in a proportional odds model with censored time-lagged outcome in a randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Substudy Analysis Cohorts |
18; 21; 25; 21; 12; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19 (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 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.
Exclusion Criteria
- 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 SOC.
- 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
Additional agent-specific criteria also apply, and are listed in the substudy records Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606) Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)
Data sourced from ClinicalTrials.gov (NCT04843761) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.