Phase 2
Completed N=60
Atovaquone for Treatment of COVID-19
Source: ClinicalTrials.gov NCT04456153 ↗Enrolled (actual)
60
Serious AEs
16.7%
Results posted
Dec 2021
Primary outcomePrimary: Primary Analysis — -1.906; 2.629; 4.073 log 10 (copies/mL) — p=0.170
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Analysis |
-1.906; 2.629; 4.073 | 0.170 |
| SECONDARY Secondary Between Group Differences in Viral Load |
0.129; 5.342; 4.406; 0.107; 4.329; 3.760 | 0.051 |
| SECONDARY Change in Viral Load at Day 10 Stratified by Sex |
-1.8732; 0.555 | — |
| SECONDARY Percentage With 2 Log Viral Load Drop at Day 3 |
15; 20 | — |
| SECONDARY Number of Participants With Change in Ordinal Scale ≥2 Points by Day 15. |
25; 9 | 0.68 |
| SECONDARY Area Under the Curve Copies/ml*Day at Day 7 |
38.39; 36.09 | 0.76 |
| SECONDARY Stratifed by Remdesivir |
-0.754; -2.010 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours
- Age ≥18 years old
- Able to provide informed consent, or (as allowed by IRB), immediate availability of designated legally authorized representative to provide consent by proxy
- Anticipated hospitalization for >48 hours
Exclusion Criteria
- Participation in any other clinical trial with antiviral activity against COVID-19
- Breastfeeding women
- Known hypersensitivity to atovaquone or formulation excipient
- Active treatment with rifampin
- HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma gondii
- Not expected to survive for 72 hours. 7) >14 days from symptom onset
Data sourced from ClinicalTrials.gov (NCT04456153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.