Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Drug: Atovaquone/Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atovaquone/Azithromycin<br>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<br>* 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)<br>* Other names: Mepron/Zithromax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virology Cure Rate | COVID-19 serology testing | 10 days | 

Secondary Outcome Measures

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