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ACTIV-6 Trials

A service from the RADS2 team

Introduction to the Algorithm

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

Sponsors

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activ-6 logo
Emory Real-time Analytics, Data Science and Decision Support (RADS2)
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    • Sepsis Prediction
    • Unplanned ED Admission (UEDA)
    • eARDS
  • Clinical Operations
    • COVID-19 Patient Care Dashboard
    • Health Equity Data Sandbox
    • Mechanical Ventilation
    • CRRT
  • Team

Stakeholders

Igho Ofotokun, MD, MSc
Co-Principal Investigator, BIRCWH
Professor of Medicine, Emory University School of Medicine

Igho is a Professor of Medicine at Emory University. He has devoted his entire career to translational research, the care of women living with HIV/AIDS, and mentoring early career investigators in patient-oriented research in women’s health.

Igho Ofotokun

Paulina Rebolledo MD, MSc
Assistant Professor
Department of Medicine

Dr. Rebolledo is an assistant professor with dual appointments in the School of Medicine (Department of Medicine, Division of Infectious Disease) and the School of Public Health (Department of Global Health).

Paulina Rebolledo

Nadine Rouphael, MD
Associate Professor, Medicine (Infectious Diseases),
Emory School of Medicine
Site Director, Hope Clinic

Dr. Rouphael is currently the Clinical Core PI and Director of the Hope Clinic Unit within the NIH funded HIPC U19. She is the Hope Clinic site director and co-PI for the Vaccine Treatment and Evaluation Unit (VTEU) and an investigator for HIV Clinical Trials.

Nadine Rouphael
Emory University Homepage

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