Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

NCT04339426 | Terminated Phase 2 FDA Drug

• 1 other identifier: HRI-COVID-19-Anti-Malarial-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Virology Cure Rate

  COVID-19 serology testing

  10 days

Secondary Outcomes (2)

• Incidence of GI adverse events

  47 days

• Cardiac Toxicity

  10 days

Other Outcomes (2)

• Changes in WBC w Diff, B cells, T cells, NK cells

  10 days

• Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a

  10 days

Study Arms (1)

Atovaquone/Azithromycin

EXPERIMENTAL

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)

Drug: Atovaquone/Azithromycin

Interventions

Atovaquone/Azithromycin DRUG

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)

Also known as: Mepron/Zithromax

Atovaquone/Azithromycin

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (1)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Atovaquone; Azithromycin

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; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Michael Gordon, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: April 20, 2020
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)