COVID-19Phase 3HyAzOUTNCT04334382
Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19
A Phase 3 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,550 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2020to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Valerie T Aston, MBA, 801-507-4606, Valerie.Aston@imail.org
Jake Krong, 801-507-9333, Jake.Krong@imail.org
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84112
Estelle Harris, MD, 801-581-7806
About this study
Official title: Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial
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.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Azithromycin
- Keywords
- SARS-Co-V-2, Hydroxychloroquine, 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.
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.
AzithromycinDrug
Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Not described Receives: Drug: Hydroxychloroquine |
| Azithromycin | Active comparator | Not described Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization within 14 days of enrollment
Admitted to a hospital (not merely kept for emergency room observation)
Measured: From enrollment to 14 days after enrollment
Secondary outcomes (4)
Duration of COVID-19-attributable symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: Admission (day 1) to 28 days after admission (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start2 Apr 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Utah Department of Health
- Responsible party
- Principal investigator, Brandon Webb, Intermountain Health Care, Inc.
- Investigators
- Brandon Webb, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334382
- Sponsor's protocol ID
- 1051360
- Acronym
- HyAzOUT
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04334382
- Acronym / sponsor ID
- HyAzOUT / 1051360
- Conditions
- COVID-19
- Keywords
- SARS-Co-V-2, Hydroxychloroquine, Azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah, Utah Department of Health
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
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 compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine |
| Azithromycin | Active comparator | Drug: Azithromycin |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| HydroxychloroquinePatients 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. | Drug | Hydroxychloroquine |
| AzithromycinPatients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5. | Drug | Azithromycin |
Primary outcome
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)
4 secondary outcomes
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)
Ventilator-free days at 28 days
Time frame: Admission (day 1) to 28 days after admission (day 28)
ICU-free days at 28 days
Time frame: Admission (day 1) to 28 days after admission (day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No. 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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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.
Brandon Webb, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by Intermountain Health Care, Inc. at 2 sites 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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie T Aston, MBA (8015074606, Valerie.Aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization within 14 days of enrollment (time frame: From enrollment to 14 days after enrollment). 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 9 Apr 2020.