ACTIV-6 trial is a NIH funded large, randomized, placebo-controlled Phase 3 clinical trial. The aim of this is to test several existing prescription and over the counter medications to treat symptoms of COVID-19. The trial will provide evidence-based treatment options for adult patients suffering from mild to moderate symptoms and are not sick enough to be hospitalized (1)(2)
The RADS2 team has developed a dashboard to support the ACTIV-6 project. The purpose of the study is to evaluate the effectiveness of repurposed medications [Ivermectin,Fluvoxamine, Fluticasone] in reducing symptoms of nonhospitalized participants with mild to moderate COVID-19.
The dashboard displays COVID positive patients who are then screened for the following eligibility criteria to participate in the study:
Age 30 or older
Confirmed SARS-CoV-2 infection by PCR or antigen test within 10 days of screening
Two or more symptoms of acute infection for ≤ 7 days (fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, headache, sore throat, nasal symptoms, new loss of sense of taste or smell)
No prior diagnosis of COVID, no recent hospitalization, no known allergy or contraindication to the study drug
Not pregnant, No ESRD or dialysis, No liver failure
No use of warfarin, CYP3A4, P-gp inhibitory drugs, or CYPD3A4 substrates (our study team will screen for these meds when we talk to the patient)
Patients who meet the criteria will be asked for their willingness to take any of the following medications and will be randomized to the study arms that they are willing to take:
Ivermectin or placebo: They will receive instructions on the # of tablets to take daily for 3 consecutive days based on their weight
Fluvoxamine or placebo: 50 mg BID for 10 days
Fluticasone or placebo: 200 ug inhaled, once daily for 14 days