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Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339426
Recruitment Status : Terminated (Closed due to poor enrollment)
First Posted : April 9, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
HonorHealth Research Institute

Study Description
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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
Covid19 Drug: Atovaquone/Azithromycin 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
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Study Type : Interventional  (Clinical Trial)
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 : April 20, 2020
Actual Primary Completion Date : February 11, 2022
Actual Study Completion Date : February 11, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Mepron/Zithromax


Outcome Measures
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Primary Outcome Measures :
  1. Virology Cure Rate [ Time Frame: 10 days ]
    COVID-19 serology testing


Secondary Outcome Measures :
  1. Incidence of GI adverse events [ Time Frame: 47 days ]
    Measure incidence of diarrhea, vomiting, nausea and constipation

  2. Cardiac Toxicity [ Time Frame: 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 [ Time Frame: 10 days ]
    Measure blood counts

  2. Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a [ Time Frame: 10 days ]
    Measure changes in plasma cytokines throughout course of infection


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339426


Locations
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United States, Arizona
HonorHealth
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
HonorHealth Research Institute
Investigators
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Principal Investigator: Michael Gordon, MD HonorHealth Research Institute
More Information
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT04339426    
Other Study ID Numbers: HRI-COVID-19-Anti-Malarial-001
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Atovaquone
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action