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ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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.

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 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).

Join this Trial

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Study Stats
Protocol No.
21-000673
Category
Pulmonary Disease
Other
Contact
Julia Vargas
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04843761
For detailed technical eligibility, visit ClinicalTrials.gov.