Status:
TERMINATED
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
Lead Sponsor:
HonorHealth Research Institute
Conditions:
Covid19
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
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 azithromyc...
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 determi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04339426
Start Date
April 20 2020
End Date
February 11 2022
Last Update
March 4 2022
Active Locations (1)
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1
HonorHealth
Scottsdale, Arizona, United States, 85258