Overview

Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
HonorHealth Research Institute
Treatments:
Atovaquone
Azithromycin
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
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