Trial record 1 of 11 for:
utah and outpatient | COVID-19
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT)
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| ClinicalTrials.gov Identifier: NCT04334382 |
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Recruitment Status :
Recruiting
First Posted : April 6, 2020
Last Update Posted : April 9, 2020
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Sponsor:
Intermountain Health Care, Inc.
Collaborators:
University of Utah
Utah Department of Health
Information provided by (Responsible Party):
Brandon Webb, Intermountain Health Care, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Hydroxychloroquine Drug: Azithromycin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1550 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial |
| Actual Study Start Date : | April 2, 2020 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Hydroxychloroquine |
Drug: Hydroxychloroquine
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. |
| Active Comparator: Azithromycin |
Drug: Azithromycin
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5. |
Primary Outcome Measures :
- Hospitalization within 14 days of enrollment [ Time Frame: From enrollment to 14 days after enrollment ]Admitted to a hospital (not merely kept for emergency room observation)
Secondary Outcome Measures :
- Duration of COVID-19-attributable symptoms [ Time Frame: From enrollment to 14 days after enrollment ]
- Hospital-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]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
- Ventilator-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]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
- ICU-free days at 28 days [ Time Frame: Admission (day 1) to 28 days after admission (day 28) ]ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult, Age>44 years, competent to provide consent
- Confirmed COVID-19, via a positive nucleic acid assay for COVID-19 within the last 7 days
Exclusion Criteria:
- Participants already prescribed chloroquine, hydroxychloroquine, or azithromycin
- Allergy to hydroxychloroquine or azithromycin
- History of bone marrow transplant
- Known G6PD (Glucose-6-Phosphate Dehydrogenase Deficiency) deficiency
- Chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or Glomerular Filtration Rate < 20ml/min/1.73m2
- Liver disease (e.g. Child Pugh score ≥ B or AST (Aspartate Transaminase)>2 times upper limit)
- Psoriasis
- Porphyria
- Known cardiac conduction delay (QTc > 500mSec) or taking any prescription medications known to prolong QT interval
- Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
- Prisoner
- Weight < 35kg
- Inability to follow-up - no cell phone or no address or not Spanish or English speaking
- Receipt of any experimental treatment for SARS-CoV-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation
- No symptoms attributable to COVID-19
- Pregnant or nursing
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334382
Contacts
| Contact: Valerie T Aston, MBA | 8015074606 | Valerie.Aston@imail.org | |
| Contact: David P Tomer, MS | 801-507-4694 | David.Tomer@imail.org |
Locations
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84107 | |
| Contact: Valerie T Aston, MBA 801-507-4606 Valerie.Aston@imail.org | |
| Contact: Jake Krong 801-507-9333 Jake.Krong@imail.org | |
| University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Estelle Harris, MD 801-581-7806 | |
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Utah Department of Health
Investigators
| Principal Investigator: | Brandon Webb, MD | Intermountain Health Care, Inc. |
| Responsible Party: | Brandon Webb, Director, Transplant Infectious Diseases, Intermountain Health Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT04334382 |
| Other Study ID Numbers: |
1051360 |
| First Posted: | April 6, 2020 Key Record Dates |
| Last Update Posted: | April 9, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Brandon Webb, Intermountain Health Care, Inc.:
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SARS-Co-V-2 Hydroxychloroquine Azithromycin |
Additional relevant MeSH terms:
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Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |