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Trial record 1 of 2 for:    atovaquone | covid
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456153
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mamta Jain, 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)
Estimated 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 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. Viral Load [ Time Frame: Up to 16 days ]
    Log copy number/ml by RT-PCR) from saliva collection at Day 8 from trial entry, or at hospital discharge



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


Contacts
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Contact: Mamta Jain 214-648-7174 Mamta.Jain@UTSouthwestern.edu
Contact: Tianna Petersen 214-590-0611 Tianna.Petersen@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Mamta Jain, M.D.       Mamta.Jain@UTSouthwestern.edu   
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
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Responsible Party: Mamta Jain, 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
Last Update Posted: July 30, 2020
Last Verified: July 2020

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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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Atovaquone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action