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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Utah Department of Health | OTHER |
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This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental |
| |
| Azithromycin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight < 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization within 14 days of enrollment | Admitted to a hospital (not merely kept for emergency room observation) | From enrollment to 14 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of COVID-19-attributable symptoms | From enrollment to 14 days after enrollment | |
| Hospital-free days at 28 days | Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie T Aston, MBA | Contact | 8015074606 | Valerie.Aston@imail.org | |
| David P Tomer, MS | Contact | 801-507-4694 | David.Tomer@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Brandon Webb, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Recruiting | Murray | Utah | 84107 | United States |
In order to protect patient privacy and comply with relevant regulations, identified data are unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
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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 |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Azithromycin | Drug | Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5. |
|
| Admission (day 1) to 28 days after admission (day 28) |
| Ventilator-free days at 28 days | Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score | Admission (day 1) to 28 days after admission (day 28) |
| ICU-free days at 28 days | ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score | Admission (day 1) to 28 days after admission (day 28) |
| University of Utah | Not yet recruiting | Salt Lake City | Utah | 84112 | United States |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |