Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

Covid19 Clinical Trial

Official title:

Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04339426
• Other study ID #: HRI-COVID-19-Anti-Malarial-001
• Status: Terminated
• Phase: Phase 2
• Start date: April 20, 2020
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2022
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Atovaquone/Azithromycin
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)

Locations

Country	Name	City	State
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in WBC w Diff, B cells, T cells, NK cells	Measure blood counts	10 days
Other	Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a	Measure changes in plasma cytokines throughout course of infection	10 days
Primary	Virology Cure Rate	COVID-19 serology testing	10 days
Secondary	Incidence of GI adverse events	Measure incidence of diarrhea, vomiting, nausea and constipation	47 days
Secondary	Cardiac Toxicity	12-Lead ECG daily if QTc >500 msec	10 days