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Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04339426
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
HonorHealth Research Institute

Tracking Information
First Submitted Date  ICMJE April 7, 2020
First Posted Date  ICMJE April 9, 2020
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
Virology Cure Rate [ Time Frame: 10 days ]
COVID-19 serology testing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2020)
  • Safety and Tolerability of combination therapy [ Time Frame: 47 days ]
    Incidence of GI adverse events
  • Cardiac Toxicity [ Time Frame: 10 days ]
    12-Lead ECG daily if QTc >500 msec
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2020)
  • Changes in WBC w Diff, B cells, T cells, NK cells [ Time Frame: 10 days ]
    Measure blood counts
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: April 7, 2020)
Exploratory - Immune response [ Time Frame: 10 days ]
Plasma Cytokines, Genomics
 
Descriptive Information
Brief Title  ICMJE Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
Official Title  ICMJE Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE 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
Study Arms  ICMJE 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)
Intervention: Drug: Atovaquone/Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2020)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Lewandowski, RN 480-583-0760 klewandowski@honorhealth.com
Contact: Heather Lane 480-323-1081 hlane@honorhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04339426
Other Study ID Numbers  ICMJE HRI-COVID-19-Anti-Malarial-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HonorHealth Research Institute
Study Sponsor  ICMJE HonorHealth Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Gordon, MD HonorHealth Research Institute
PRS Account HonorHealth Research Institute
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP