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Atovaquone for Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456153
Recruitment Status : Completed
First Posted : July 2, 2020
Results First Posted : December 14, 2021
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Mamta K. Jain, MD,MPH, University of Texas Southwestern Medical Center

Brief 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


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Experimental Group Drug: Placebo Group Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Atovaquone for Treatment of COVID-19
Actual Study Start Date : July 22, 2020
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Atovaquone

Arm Intervention/treatment
Experimental: standard of care therapy with atovaquone
The first treatment group will receive 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: 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
Other Name: Atovaquone

Placebo Comparator: standard of care therapy with matching placebo
The second treatment group will receive continued standard of care therapy together with matching placebo.
Drug: Placebo Group
Continued standard of care therapy together with matching placebo




Primary Outcome Measures :
  1. Primary Analysis [ Time Frame: Day 1 to Day 10 ]
    Between group differences in viral load (Log copy number/ml) using generalized linear mixed-effect models of repeated measures (GLMM), using data from all available samples


Secondary Outcome Measures :
  1. Secondary Between Group Differences in Viral Load [ Time Frame: baseline to day7 ]
    Change in viral load at Day 3, 5, and 7 days. This shows the group differences between intervention and placebo and log 10 viral load at specific days 3, 5, and 7 for atovaquone arm and placebo arm.

  2. Change in Viral Load at Day 10 Stratified by Sex [ Time Frame: baseline to day 10 ]
    Between group differences in viral load (Log copy number/ml) using GLMM stratified by

  3. Percentage With 2 Log Viral Load Drop at Day 3 [ Time Frame: baseline to day 3 ]
    Between group comparison of time to drop in viral load (Log copy number/ml) of 2 log units using Kaplan-Meier estimation. Examined the percentage of participants who achieved this viral load drop in 3 days.

  4. Number of Participants With Change in Ordinal Scale ≥2 Points by Day 15. [ Time Frame: Day 15 ]
    Ordinal scale 1 indicated death, and higher scores were various degrees of hospitalizations and incapacity to being out of hospital. Ordinal Scale 1-7 with higher score indicating improvement in clinical status. Change of ≥2 points on the ordinal scale by Day 15 using chi-square analysis

  5. Area Under the Curve Copies/ml*Day at Day 7 [ Time Frame: day 7 ]
    This is a alternative method of measurement of area which examines the viral load ( copies/ml )(y-axis) by day (x-axis) using the trapezoidal method. The area under the curve was calculated via the trapezoidal rule. As such, this is a numeric value that is different than the traditional use of the term "mean" or "median." However, in order to calculate a measure of error associated with this quantity, bootstrapping with 500 replications would need to be performed to assess statistical significance or lack thereof. The mean of the bootstrap samples could be reported as the "mean area under the curve."

  6. Stratifed by Remdesivir [ Time Frame: day 10 ]
    change in log RNA 10 day 1 to 10 stratified by remdesivir by GLMM



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456153


Locations
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United States, Texas
University of Texas Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Mamta Jain, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Hesham Sadek, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Ezimamaka Ajufo, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Reuben Arasaratnam, M.D. University of Texas Southwestern Medical Center
Principal Investigator: James De Lemos, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Helen King, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Amneris Luque, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Jessica Meisner, M.D. University of Texas Southwestern Medical Center
Principal Investigator: Satish Mocherla, M.D. University of Texas Southwestern Medical Center
Principal Investigator: John Schoggins, Ph.D. University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Mamta K. Jain, MD,MPH, University of Texas Southwestern Medical Center:
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Responsible Party: Mamta K. Jain, MD,MPH, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04456153    
Other Study ID Numbers: STU-2020-0707
First Posted: July 2, 2020    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: December 14, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no specified plan made.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Atovaquone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action