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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 September 2023 |
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Main ID: |
NCT04501978 |
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Date of registration:
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03/08/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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ACTIV-3: Therapeutics for Inpatients With COVID-19
TICO |
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Scientific title:
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A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 |
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Date of first enrolment:
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August 4, 2020 |
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Target sample size:
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2753 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04501978 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Denmark
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Georgia
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Greece
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India
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Mexico
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Mozambique
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Nigeria
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Poland
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Singapore
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Spain
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Switzerland
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Uganda
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Prof. James Neaton |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSIGHT Statistical and Coordinating Centre, University of Minnesota |
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Name:
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Prof. Jens Lundgren |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed informed consent.
- Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19
infection.
- Symptoms of COVID-19 for = 12 days.
- Require admission to hospital for acute medical care (not for purely public health or
quarantine purposes).
Exclusion Criteria:
- Patients who have received plasma from a person who recovered from COVID-19 or who
have received neutralizing monoclonal antibodies at any time prior to hospitalization.
- Patients not willing to abstain from participation in other COVID-19 treatment trials
until after Day 5 of the study. Co-enrollment in certain trials that compare
recommended Standard of Care treatments may be allowed, based on the opinion of the
study leadership team.
- Any condition which, in the opinion of the responsible investigator, participation
would not be in the best interest of the participant or that could prevent, limit, or
confound the protocol-specified assessments.
- Patients considered unable to participate in study procedures.
- Women of child-bearing potential who are not already pregnant at study entry and who
are unwilling to acknowledge strong advice to abstain from sexual intercourse with men
or practice appropriate contraception through 18 months of the study.
- Women of child-bearing potential who are unwilling to acknowledge the strong advice to
abstain from sexual intercourse with men or practice appropriate contraception through
5 weeks of the study (PF-07304814 investigational agent).
- Pregnant women (PF-07304814 investigational agents).
- Nursing mothers (PF-07304814 investigational agents).
- Men who are unwilling to acknowledge the strong advice to abstain from sexual
intercourse with women of child-bearing potential or to use barrier contraception
through 18 months of the study.
- Men who are unwilling to acknowledge the strong advice to abstain from sexual
intercourse with women of child-bearing potential or to use barrier contraception
through 5 weeks of the study (PF-07304814 investigational agent).
- Presence at study enrollment of any of the following:
1. stroke
2. meningitis
3. encephalitis
4. myelitis
5. myocardial ischemia
6. myocarditis
7. pericarditis
8. symptomatic congestive heart failure
9. arterial or deep venous thrombosis or pulmonary embolism
- Current or imminent requirement for any of the following:
1. invasive mechanical ventilation
2. ECMO (extracorporeal membrane oxygenation)
3. Mechanical circulatory support
4. vasopressor therapy
5. commencement of renal replacement therapy at this admission (i.e. not patients on
chronic renal replacement therapy).
- Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C)
or acute liver failure (PF-07304814 investigational agent).
- Participants receiving any medications or substances that are strong inhibitors or
inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
- Patients will be excluded if taking drugs which have a narrow therapeutic window that
are substrates of CYP3A4, including but not limited to: astemizole, cisapride,
cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus,
tacrolimus, and terfenadine (PF-07304814 investigational agent).
- Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism
(Prior to initial futility assessment of PF-07304814 investigational agent).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Covid19
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Intervention(s)
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Biological: LY3819253
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Biological: AZD7442
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Drug: MP0420
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Biological: Remdesivir
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Drug: PF-07304814
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Biological: BRII-196/BRII-198
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Drug: Placebo
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Biological: VIR-7831
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Primary Outcome(s)
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Time from randomization to sustained recovery
[Time Frame: Up to Day 90]
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Secondary Outcome(s)
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Change in neutralizing antibody levels
[Time Frame: Baseline to Days 1, 3, 5, 28 and 90]
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Incidence of clinical organ failure
[Time Frame: Thru Day 28]
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All-cause mortality
[Time Frame: Thru Day 90]
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Change in SARS-CoV-2 neutralizing antibody levels
[Time Frame: Baseline to Days 1, 3, 5, 28 and 90]
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Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
[Time Frame: Thru Days 5 and 28]
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Composite of death or serious clinical COVID-19 related events
[Time Frame: Thru Day 90]
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Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
[Time Frame: 14 days]
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Change in overall titers of antibodies
[Time Frame: Baseline to Days 1, 3, 5, 28 and 90]
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Composite of cardiovascular events and thromboembolic events
[Time Frame: Thru Day 90]
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Composite of SAEs or death
[Time Frame: Thru 18 months]
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Days alive outside short-term acute care hospital
[Time Frame: Up to Day 90]
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Pulmonary+ ordinal outcome
[Time Frame: Days 1-7]
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Pulmonary ordinal outcome
[Time Frame: Days 1-7, 14 and 28]
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Incidence of home use of supplemental oxygen above pre-morbid oxygen use
[Time Frame: 18 months]
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Composite of time to sustained recovery and mortality
[Time Frame: Thru Day 90]
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Incidence of infusion reactions
[Time Frame: Thru Day 0]
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Secondary ID(s)
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014 / ACTIV-3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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