Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: Atovaquone/Azithromycin

• Registration Number: NCT04339426
• Lead Sponsor: HonorHealth Research Institute

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 Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-09
• Study Start: 2020-04-20
• Status Verified: 2022-02
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atovaquone/Azithromycin	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)

Primary Outcome Measures

Name	Time	Method
Virology Cure Rate	10 days	COVID-19 serology testing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States