ACTIV-3: Therapeutics for Inpatients With COVID-19
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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).
- 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. - 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 abstain from sexual intercourse with men, or practice appropriate contraception through Day 90 of the study. - Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Day 90 of the study. - [Stage 1 only] 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 - [Stage 1 only] 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). Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
ACTIV-3 Drug plus SOC
|Participants in this study will be randomized to receive ACTIV-3 Drug plus Standard of Care (SOC) or placebo plus SOC||
Placebo plus SOC
|The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study||
- NCT ID
- Active, not recruiting
- National Institute of Allergy and Infectious Diseases (NIAID)
This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression. The protocol is for a randomized, blinded, controlled platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. This platform study involves 2 stages. In stage 1, safety will be evaluated and two intermediate outcomes will be assessed to determine whether a drug advances to stage 2. Treatments considered to have demonstrated unacceptable risks relative to benefits, or those which do not reach the effectiveness threshold for the stage 1 intermediate outcomes, will not advance to stage 2. In some cases, stage 1 may include 2 or 3 doses of the same investigational drug, which will be considered separate drugs for the purpose of the study. Investigational drugs with reasonably well-established safety profiles and evidence of effectiveness (i.e. at least equivalent to the criteria for advancement of a drug from stage 1 to stage 2) may enter the study directly at stage 2. Conversely, for drugs with minimal pre-existing safety evidence, the pace of stage 1 will initially be restricted and there will be an early review of safety data by an independent Data and Safety Monitoring Board (DSMB). A Phase 1 dose escalation study for some investigational drugs may be required, and if so, the Phase 1 study would precede stage 1 and be carried out as a separate protocol. The international trials within this protocol will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.