ACTIV-6: COVID-19 Study of Repurposed Medications - Arm D (Ivermectin 600)
Condition: Covid19
MeSH terms: COVID-19
Intervention: Ivermectin; Placebo
Intervention description: Each participant will receive a sufficient quantity of 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with "123" over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use.; Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Intervention MeSH terms: Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Placebo-Controlled, Randomized Trial
Masking: Double (Participant, Care Provider)
Masking description: The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo because they will be matching.
Enrollment: 1459.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; COVID-19; ivermectin; Placebo; Duke University Health System; Outcomes; Duke Clinical Research Institute; ACTIV 6; ACTIV

Summary:

      The purpose of this study is to evaluate the effectiveness of repurposed medications (study
      drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19.
      Participants will receive either study drug or placebo. They will self-report any new or
      worsening symptoms or medical events they may experience while taking study drug or placebo.
      This study is intended to be all remote with no in person visits, unless the study team feels
      it is in the best interest of a participant to see them in person.

      Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the
      activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov
      entry and will include "Pro00107921" in the Unique Protocol ID.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Informed Consent

          -  Age ≥ 30 years old

          -  Confirmed SARS-CoV-2 infection (or reinfection) by any authorized or approved
             polymerase chain reaction (PCR) or antigen test collected within 10 days of screening

          -  Two or more current symptoms of acute infection for ≤7 days. Symptoms include the
             following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches,
             chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell

        Exclusion Criteria:

          -  Current or recent (within 10 days of screening) hospitalization for COVID-19 infection

          -  Current or planned participation in another interventional trial to treat COVID-19, at
             the discretion of the study principal investigator (PI)

          -  Current or recent use (within the last 14 days) of study drug or study drug/device
             combination*

          -  Known allergy/sensitivity or any hypersensitivity to components of the study drug or
             placebo*

          -  Known contraindication(s) to study drug including prohibited concomitant medications
             (see Appendices)*

        Additional Appendix-Level Exclusion Criteria:

          -  End-stage renal disease on renal replacement therapy

          -  Liver failure or decompensated cirrhosis

          -  Current or planned use of the following drugs during the study, listed by drug class:

          -  Antiarrhythmic/antihypertensive drug class: quinidine, amiodarone, diltiazem,
             spironolactone, verapamil

          -  Antibiotic-macrolides drug class: clarithromycin, erythromycin

          -  Antifungal drug class: itraconazole, ketoconazole

          -  Immunosuppressant drug class: cyclosporine, tacrolimus

          -  Anti-HIV drug class: indinavir, ritonavir

          -  Nursing mothers

          -  Pregnancy