Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

HonorHealth Research Institute

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Atovaquone/Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04339426

HRI-COVID-19-Anti-Malarial-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

Atovaquone/Azithromycin

Experimental group

Description:

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)

Treatment:

Drug: Atovaquone/Azithromycin