Phase 3
N=473
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04843761 ↗Enrolled (actual)
473
Serious AEs
—
Results posted
Oct 2025
Primary outcome: Primary: Substudy Analysis Cohorts — 18; 21; 25; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Remdesivir (Biological); Remdesivir Placebo (Drug); Aviptadil (Biological); Aviptadil Placebo (Drug); Corticosteroid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Substudy Analysis Cohorts |
18; 21; 25; 21; 12; 11 | — |
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)
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). 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.