ACTIV-2: A Study for Outpatients With COVID-19
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. Participants in the study will be treated with either a study drug or with placebo.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Signed informed consent. - Positive test for COVID-19 up to 7 days before participation in study. - Able to begin study treatment no later than 10 days from self-reported onset of COVID-19 related symptom(s): - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°C (100.4°F) - One or more of the following signs/symptoms within 48 hours of participating in the study: - fever or feeling feverish - cough - shortness of breath or difficulty breathing at rest or when active - sore throat - body pain or muscle pain/aches - fatigue - headache - chills - blocked nose/nasal congestion - runny nose - loss of taste or smell - nausea or vomiting - diarrhea - temperature ≥ 38°C (100.4°F) - Oxygen levels of ≥92% when resting (measured by study staff within 48 hours of participating in the study), unless participant is receiving long-term supplementary oxygen for an underlying lung condition. - Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
- History of or current hospitalization for COVID-19. - Current need for hospitalization or immediate medical attention. - Any use of the following medications up to 30 days before participating in the study: - Hydroxychloroquine (except for long-term autoimmune diseases) - Chloroquine and/or ivermectin (unless used for parasitic infection) - Remdesivir, systemic and inhaled steroids (unless used for long-term conditions) - HIV protease inhibitors (unless used long-term for HIV infection) - Receipt of plasma from a person who recovered from COVID-19 any time before participating in the study. - Receipt of a SARS-CoV-2 vaccine any time before participating in the study. - Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases). - Receipt of systemic steroids (e.g. prednisone, dexamethasone) or inhaled steroids up to 30 days before participating in the study, unless this is a stable dose for a long-term condition. - Known allergy/sensitivity or hypersensitivity to study drug or placebo. - Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study. Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
- Phase 2/Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
|Participants in this study will be randomized to receive ACTIV2 Drug or placebo||
|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||
- 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 study is designed to transition from phase 2 to phase 3 in the same trial, with or without a pause in enrollment, depending on the speed of enrollment and interim results. For promising agents with limited availability, a phase 3 evaluation may occur at a later time. Up to two dose levels of the same agent may be assessed. Agents may also enter directly into phase 3 evaluation if sufficient safety and efficacy data are available from outside the trial.