Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2022-02-11

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.

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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.

Conditions

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Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Atovaquone/Azithromycin

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Mepron/Zithromax

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No