Atovaquone for Treatment of COVID-19

NCT04456153 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STU-2020-0707
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Primary Analysis

  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

  Day 1 to Day 10

Secondary Outcomes (6)

• Secondary Between Group Differences in Viral Load

  baseline to day7

• Change in Viral Load at Day 10 Stratified by Sex

  baseline to day 10

• Percentage With 2 Log Viral Load Drop at Day 3

  baseline to day 3

• Number of Participants With Change in Ordinal Scale ≥2 Points by Day 15.

  Day 15

• Area Under the Curve Copies/ml*Day at Day 7

  day 7

Study Arms (2)

standard of care therapy with atovaquone

EXPERIMENTAL

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

standard of care therapy with matching placebo

PLACEBO COMPARATOR

The second treatment group will receive continued standard of care therapy together with matching placebo.

Drug: Placebo Group

Interventions

Experimental Group DRUG

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

Also known as: Atovaquone

standard of care therapy with atovaquone

Placebo Group DRUG

Continued standard of care therapy together with matching placebo

standard of care therapy with matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Atovaquone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Naphthoquinones; Quinones; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

This study was not powered for clinical endpoints.

Results Point of Contact

• Title: Dr. Mamta K. Jain
• Organization: UT Southwestern Medical Center

mamta.jain@utsouthwestern.edu

2140648-9914

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: July 22, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)