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Atovaquone for Treatment of COVID-19

NCT04456153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-14

Study results available
· View outcomes & findings →

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

Conditions

Interventions

DRUG

Experimental Group

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

DRUG

Placebo Group

Continued standard of care therapy together with matching placebo

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Mamta Jain, M.D. · University of Texas Southwestern Medical Center

  • Hesham Sadek, M.D. · University of Texas Southwestern Medical Center

  • Ezimamaka Ajufo, M.D. · University of Texas Southwestern Medical Center

  • Reuben Arasaratnam, M.D. · University of Texas Southwestern Medical Center

  • James De Lemos, M.D. · University of Texas Southwestern Medical Center

  • Helen King, M.D. · University of Texas Southwestern Medical Center

  • Amneris Luque, M.D. · University of Texas Southwestern Medical Center

  • Jessica Meisner, M.D. · University of Texas Southwestern Medical Center

  • Satish Mocherla, M.D. · University of Texas Southwestern Medical Center

  • John Schoggins, Ph.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456153 on ClinicalTrials.gov