Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Phase 2TerminatedNCT04339426

HonorHealth Research Institute3 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Atovaquone/AzithromycinDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

HonorHealth

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Virology Cure Rate

COVID-19 serology testing

Time frame: 10 days

Secondary Outcomes

Incidence of GI adverse events

Measure incidence of diarrhea, vomiting, nausea and constipation

Time frame: 47 days

Cardiac Toxicity

12-Lead ECG daily if QTc \>500 msec

Time frame: 10 days

Data from ClinicalTrials.gov

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