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Closed due to poor enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Virology Cure Rate | Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Gastrointestinal Adverse Events | Measured incidence of diarrhea, vomiting, nausea, and constipation. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in White Blood Cells Over Time | Measurement of change in number of white blood cells (WBCs) throughout the course of COVID-19 infection. | 10 days |
| Change in Lymphocytes Over Time | Measurement of change in number of lymphocytes throughout the course of COVID-19 infection. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gordon, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atovaquone/Azithromycin | 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) 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atovaquone/Azithromycin | 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) 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Virology Cure Rate | Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing. | Posted | Number | Percentage of participants | 10 days |
|
|
From enrollment until 30 days after last dose of study drug, up to 47 days.
Adverse events were collected according to the NCI Common Terminology Criteria for Adverse Event (CTCAE) v5.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atovaquone/Azithromycin | 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) 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
This trial was terminated prematurely due to low enrollment and no data were collected. As a result, the effect of the intervention cannot be determined.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gordon, MD | HonorHealth Research Institute | 4803231350 | clinicaltrials@honorhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2020 | Jun 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2020 | Jun 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053626 | Atovaquone |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
| 10 days |
| 10 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Incidence of Gastrointestinal Adverse Events | Measured incidence of diarrhea, vomiting, nausea, and constipation. | Posted | Number | Number of participants affected by GI AE | 47 days |
|
|
|
| Secondary | 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. | Posted | Number | Events | 10 days |
|
|
|
| Other Pre-specified | Change in White Blood Cells Over Time | Measurement of change in number of white blood cells (WBCs) throughout the course of COVID-19 infection. | n=1 did not have WBC data for days 2 and 4. | Posted | Median | 95% Confidence Interval | cells*10^3/uL | 10 days |
|
|
|
| Other Pre-specified | Change in Lymphocytes Over Time | Measurement of change in number of lymphocytes throughout the course of COVID-19 infection. | All participants did not have reliable lymphocyte readings on day 0 (prior to study regimen start), therefore day 0 was removed from the analysis. n=1 did not have lymphocyte data for days 2 and 4. | Posted | Median | 95% Confidence Interval | cells*10^3/uL | 10 days |
|
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Facial skin trauma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Edema limbs | Vascular disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Klebsiella bacteremia | Infections and infestations | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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