Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

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

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 9, 2020
• Last Update Posted Date: December 2, 2020
• Actual Study Start Date: April 20, 2020
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2020)

Virology Cure Rate [ Time Frame: 10 days ]

COVID-19 serology testing

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 7, 2020): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Karen Lewandowski, RN; 480-583-0760; klewandowski@honorhealth.com

Contact: Heather Lane; 480-323-1081; hlane@honorhealth.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04339426
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: HonorHealth Research Institute
• Study Sponsor: HonorHealth Research Institute
• Collaborators: Not Provided

Investigators

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

• PRS Account: HonorHealth Research Institute
• Verification Date: December 2020