Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Overview

This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.

Full Title of Study: “Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 11, 2022

Detailed Description

This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.

Interventions

  • Drug: Atovaquone/Azithromycin
    • Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)

Arms, Groups and Cohorts

  • Experimental: Atovaquone/Azithromycin
    • Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)

Clinical Trial Outcome Measures

Primary Measures

  • Virology Cure Rate
    • Time Frame: 10 days
    • COVID-19 serology testing

Secondary Measures

  • Incidence of GI adverse events
    • Time Frame: 47 days
    • Measure incidence of diarrhea, vomiting, nausea and constipation
  • Cardiac Toxicity
    • Time Frame: 10 days
    • 12-Lead ECG daily if QTc >500 msec

Participating in This Clinical Trial

Inclusion Criteria

  • Male and Female patients age 18 years or older – COVID-19 confirmed positive test results – High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score – Hematology criteria: ANC >500 cells/mcl, HGB >9 g/dl, Platelet count >75,000/mcl – Metabolic criteria: Serum creatinine <2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) >30 ml/min, AST/ALT <5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin <ULN) Exclusion Criteria:

  • COVID-19 negative test result – Inability to adhere to study protocol requirements – Inability to provide informed consent – Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study – Pregnant and breastfeeding individuals – QTc interval greater than 470 msecs at baseline – History of hypersensitivity to atovaquone and/or azithromycin. – History of known intolerance to atovaquone and/or azithromycin

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HonorHealth Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Gordon, MD, Principal Investigator, HonorHealth Research Institute

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