Covid19Phase 2NCT04339426
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
A Phase 2 study testing Atovaquone/Azithromycin in people with Covid19, run by HonorHealth Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19
- What is being tested?
- Atovaquone/Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 11 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Atovaquone/Azithromycin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atovaquone/AzithromycinDrug
Also called Mepron/Zithromax
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Atovaquone/Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virology Cure Rate
Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing.
Measured: 10 days
Secondary outcomes (2)
Incidence of Gastrointestinal Adverse Events
Measured incidence of diarrhea, vomiting, nausea, and constipation.
Measured: 47 days
Cardiac Toxicity
Cardiac toxicity measured by 12-lead electrocardiogram (ECG) daily if QTc >500 msec. The number of QTc >500 msec events after beginning study regimen is reported here.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start20 Apr 2020
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
Why it stopped: Closed due to poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gordon, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339426
- Sponsor's protocol ID
- HRI-COVID-19-Anti-Malarial-001
- Status last verified
- Dec 2024
- First submitted
- 7 Apr 2020
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04339426
- Acronym / sponsor ID
- HRI-COVID-19-Anti-Malarial-001
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atovaquone/Azithromycin | Experimental | Drug: Atovaquone/AzithromycinAtovaquone 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) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atovaquone/AzithromycinAlso: Mepron/ZithromaxAtovaquone 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) | Drug | Atovaquone/Azithromycin |
Primary outcome
Virology Cure Rate
Time frame: 10 days
Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing.
2 secondary outcomes
Incidence of Gastrointestinal Adverse Events
Time frame: 47 days
Cardiac Toxicity
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gordon, MD principal investigator
HonorHealth Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atovaquone/Azithromycin in people with Covid19, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virology Cure Rate (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.