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Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Sponsor
HonorHealth Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT04339426
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
21.7
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
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)

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)
Other Names:
  • Mepron/Zithromax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Virology Cure Rate [10 days]

      COVID-19 serology testing

    Secondary Outcome Measures

    1. Incidence of GI adverse events [47 days]

      Measure incidence of diarrhea, vomiting, nausea and constipation

    2. Cardiac Toxicity [10 days]

      12-Lead ECG daily if QTc >500 msec

    Other Outcome Measures

    1. Changes in WBC w Diff, B cells, T cells, NK cells [10 days]

      Measure blood counts

    2. Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a [10 days]

      Measure changes in plasma cytokines throughout course of infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HonorHealth Scottsdale Arizona United States 85258

    Sponsors and Collaborators

    • HonorHealth Research Institute

    Investigators

    • Principal Investigator: Michael Gordon, MD, HonorHealth Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HonorHealth Research Institute
    ClinicalTrials.gov Identifier:
    NCT04339426
    Other Study ID Numbers:
    • HRI-COVID-19-Anti-Malarial-001
    First Posted:
    Apr 9, 2020
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    COVID-19
    Azithromycin
    Atovaquone

    Study Results

    No Results Posted as of Mar 4, 2022