ACTIV-2 Study

Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of non-hospitalized adults with COVID-19.

The trial is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure.

Version 7 of the protocol provides for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent. Agents that graduate to phase III after initiation of this protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator, the monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron), which has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent.

Participant Eligibility

Inclusion Criteria:

• Exposure and symptom onset (within 7 days of Sx onset, 7 days of positive test)
• Testing date and location
• Vaccination history (only want unvaccinated, high risk)
• Medication history (if applicable) to symptom profile

We are recruiting HIGH RISK participants:

• “High risk” and unvaccinated or not fully vaccinated (only received one dose)
• >65 years OR
• 55 yo + with cardiovascular disease (CVD) or chronic obstructive pulmonary disease (COPD) OR
• 18 yo + with BMI >35, hypertension (HTN, high blood pressure), chronic kidney disease (CKD)
• Diabetes mellitus (DM), or immunosuppressed
• Fully vaccinated (or not) with immunosuppression at risk for not responding to vaccine
• Active chemotherapy
• Hematological malignancy
• Within 1 year of HCT or solid organ transplant (SOT)
• Untreated HIV or CD4 <200
• Primary immunodeficiency
• Immunosuppression via prolonged corticosteroids (e.g., prednisone), HIV+ CD4<200, or active
• Cancer/immunomodulating treatments and anyone on post-transplant anti-rejection meds

Exclusion: any hospitalization for COVID prior to entry

Prohibited Medications:

• Hydroxychloroquine (unless used chronically for autoimmune diseases)
• Chloroquine (unless used for a parasitic infection)
• Ivermectin (unless used for a parasitic infection)
• Any antibody-based therapy for COVID-19
• Remdesivir
• Fluvoxamine (unless used chronically)
•  Colchicine (unless used for reasons other than COVID-19)
• HIV protease inhibitors (unless used chronically for HIV infection)

Contact

ACTIV-2 Researcher @ UW ACTU
(206) 773-7129