Status:
COMPLETED
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
University of Copenhagen
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
This is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19. Trials within this...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2022
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT04843761
Start Date
April 20 2021
End Date
November 20 2022
Last Update
October 24 2025
Active Locations (40)
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1
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
Tucson, Arizona, United States, 85719
2
UCSF Fresno (Site 203-005), 155 N. Fresno Street
Fresno, California, United States, 93701
3
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
Loma Linda, California, United States, 92357
4
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
Los Angeles, California, United States, 90048