Atovaquone for Treatment of COVID-19

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the current study is to accelerate the use of a clinically available therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19 addressing a serious and emergent unmet medical need.

This is a randomized, double-blind study of atovaquone therapy in adult participants hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment groups:

Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days

Treatment Group 2: continued standard of care therapy together with matching placebo

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Atovaquone

Criteria

Inclusion Criteria:

1. Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours

2. Age ≥18 years old

3. Able to provide informed consent, or (as allowed by IRB), immediate availability of designated legally authorized representative to provide consent by proxy

4. Anticipated hospitalization for >48 hours

Exclusion Criteria:

1. Participation in any other clinical trial with antiviral activity against COVID-19

2. Breastfeeding women

3. Known hypersensitivity to atovaquone or formulation excipient

4. Active treatment with rifampin

5. HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma gondii

6. Not expected to survive for 72 hours. 7) >14 days from symptom onset