search
Back to results

Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atovaquone/Azithromycin
Sponsored by
HonorHealth Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and Female patients age 18 years or older
  • COVID-19 confirmed positive test results
  • High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score
  • Hematology criteria: ANC >500 cells/mcl, HGB >9 g/dl, Platelet count >75,000/mcl
  • Metabolic criteria: Serum creatinine <2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) >30 ml/min, AST/ALT <5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin <ULN)

Exclusion Criteria:

  • COVID-19 negative test result
  • Inability to adhere to study protocol requirements
  • Inability to provide informed consent
  • Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study
  • Pregnant and breastfeeding individuals
  • QTc interval greater than 470 msecs at baseline
  • History of hypersensitivity to atovaquone and/or azithromycin.
  • History of known intolerance to atovaquone and/or azithromycin

Sites / Locations

  • HonorHealth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atovaquone/Azithromycin

Arm Description

Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)

Outcomes

Primary Outcome Measures

Virology Cure Rate
COVID-19 serology testing

Secondary Outcome Measures

Incidence of GI adverse events
Measure incidence of diarrhea, vomiting, nausea and constipation
Cardiac Toxicity
12-Lead ECG daily if QTc >500 msec

Full Information

First Posted
April 7, 2020
Last Updated
February 16, 2022
Sponsor
HonorHealth Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04339426
Brief Title
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
Official Title
Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Closed due to poor enrollment
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute

4. Oversight

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.
Detailed Description
This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atovaquone/Azithromycin
Arm Type
Experimental
Arm Description
Atovaquone 750 mg PO Q12H for up to 10 days Azithromycin 500 mg PO Day 1 followed by 250 mg PO daily for up to 10 days (Days 2-10)
Intervention Type
Drug
Intervention Name(s)
Atovaquone/Azithromycin
Other Intervention Name(s)
Mepron/Zithromax
Intervention Description
Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
Primary Outcome Measure Information:
Title
Virology Cure Rate
Description
COVID-19 serology testing
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Incidence of GI adverse events
Description
Measure incidence of diarrhea, vomiting, nausea and constipation
Time Frame
47 days
Title
Cardiac Toxicity
Description
12-Lead ECG daily if QTc >500 msec
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
Changes in WBC w Diff, B cells, T cells, NK cells
Description
Measure blood counts
Time Frame
10 days
Title
Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a
Description
Measure changes in plasma cytokines throughout course of infection
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female patients age 18 years or older COVID-19 confirmed positive test results High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score Hematology criteria: ANC >500 cells/mcl, HGB >9 g/dl, Platelet count >75,000/mcl Metabolic criteria: Serum creatinine <2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) >30 ml/min, AST/ALT <5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin <ULN) Exclusion Criteria: COVID-19 negative test result Inability to adhere to study protocol requirements Inability to provide informed consent Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study Pregnant and breastfeeding individuals QTc interval greater than 470 msecs at baseline History of hypersensitivity to atovaquone and/or azithromycin. History of known intolerance to atovaquone and/or azithromycin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gordon, MD
Organizational Affiliation
HonorHealth Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

We'll reach out to this number within 24 hrs