COVID-19Phase 2HAHPSNCT04329832

Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19

A Phase 2 study testing Hydroxychloroquine and Azithromycin in people with COVID-19, run by Intermountain Health Care, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Hydroxychloroquine and Azithromycin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 2 sitesUnited States
Study dates: 30 Mar 2020to 1 Jan 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult (age ≥ 18 years)
Confirmed OR suspected COVID-19,
Confirmed: Positive assay for COVID-19 within the last 10 days
Suspected: Pending assay for COVID-19 WITH high clinical suspicion
Scheduled for admission or already admitted to an inpatient bed

Who cannot join

Allergy to hydroxychloroquine or azithromycin
History of bone marrow transplant
Known G6PD deficiency
Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
Psoriasis
Porphyria

Show all 19Show fewer

Concomitant use of digitalis, flecainide, amiodarone, procainamide, propafenone, cimetidine, dofetilide, phenobarbital, phenytoin, or sotalol
Known history of long QT syndrome
Current known QTc>500 msec
Pregnant or nursing
Prisoner
Weight < 35kg
Seizure disorder
Severe liver disease
Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
Treating physician refuses to allow patient participation in the study
Unable to obtain informed consent
Prior enrollment in this study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Intermountain Medical Center
Murray, Utah, 84107
University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial

Conditions: COVID-19
Being tested: Hydroxychloroquine, Azithromycin
Keywords: SARS-CoV-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.

HydroxychloroquineDrug
Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
AzithromycinDrug
Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.

Study groups in NCT04329832
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.

COVID Ordinal Outcomes Scale at 14 Days
Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measured: Assessed once on day 14 after enrollment (enrollment is day 0)

Secondary outcomes (4)

Hospital-free Days at 28 Days
Calculated as number of days patient not in hospital
Measured: 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 number of days that patient is not on a ventilator up to day 28 days after admission
Measured: Admission (day 1) to 28 days after admission (day 28)
ICU-free Days at 28 Days
Calculated as number of days patient not in an ICU
Measured: Admission (day 1) to 28 days after admission (day 28)
Time to a 1-point Decrease in the WHO Ordinal Recovery Score
Time to 1-point decrease in the WHO ordinal recovery score is defined as the number of days until the ordinal outcome score drops by 1 relative to baseline on the 8-point WHO COVID Ordinal Outcomes scale, which reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measured: Admission (day 1) to 14 days after admission (day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 20201 Jan 2021

First posted1 Apr 2020
Study start30 Mar 2020
Primary completion1 Jul 2020
Study completion1 Jan 2021

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.
Publications (4)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04329832
Sponsor's protocol ID: 1051355
Acronym: HAHPS
Status last verified: Apr 2022
First submitted: 30 Mar 2020
Last updated: 20 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
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.

Publications

WHO, 2020. WHO R&D Blueprint, novel Coronavirus, COVID-19 Therapeutic Trial Synopsis. https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis
Koric A, Chang CP, Mark B, Rowe K, Snyder J, Dodson M, Deshmukh VG, Newman MG, Fraser AM, Smith KR, Date AP, Gren LH, Porucznik CA, Haaland BA, Henry NL, Hashibe M. Cardiovascular disease risk in long-term breast cancer survivors: A population-based cohort study. Cancer. 2022 Jul 15;128(14):2826-2835. doi: 10.1002/cncr.34224. Epub 2022 May 13.
PubMed 35561317
Brown SM, Peltan I, Kumar N, Leither L, Webb BJ, Starr N, Grissom CK, Buckel WR, Srivastava R, Butler AM, Groat D, Haaland B, Ying J, Harris E, Johnson S, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with COVID-19. Results of a Randomized, Active Comparator Trial. Ann Am Thorac Soc. 2021 Apr;18(4):590-597. doi: 10.1513/AnnalsATS.202008-940OC.
PubMed 33166179
Brown SM, Peltan ID, Webb B, Kumar N, Starr N, Grissom C, Buckel WR, Srivastava R, Harris ES, Leither LM, Johnson SA, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial. Ann Am Thorac Soc. 2020 Aug;17(8):1008-1015. doi: 10.1513/AnnalsATS.202004-309SD.
PubMed 32425051

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial
ClinicalTrials.gov ID: NCT04329832
Acronym / sponsor ID: HAHPS / 1051355
Conditions: COVID-19
Keywords: SARS-CoV-2, Hydroxychloroquine, Azithromycin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Intermountain Health Care, Inc.University, hospital or other
Collaborators: University of Utah
Study start: 30 Mar 2020 (actual)
Primary completion: 1 Jul 2020 (actual)
Study completion: 1 Jan 2021 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 20 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult (age ≥ 18 years)
Confirmed OR suspected COVID-19,
Scheduled for admission or already admitted to an inpatient bed

Key exclusion criteria (19 listed)

Allergy to hydroxychloroquine or azithromycin
History of bone marrow transplant
Known G6PD deficiency
Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min
Psoriasis

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 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Drug	Hydroxychloroquine
AzithromycinPatients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.	Drug	Azithromycin

Primary outcome

COVID Ordinal Outcomes Scale at 14 Days
Time frame: Assessed once on day 14 after enrollment (enrollment is day 0)
Improvement of clinical condition of the patient defined by the COVID-19 WHO ordinal Outcomes score. This scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".

4 secondary outcomes

Hospital-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)
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)
Time to a 1-point Decrease in the WHO Ordinal Recovery Score
Time frame: Admission (day 1) to 14 days after admission (day 14)

Results and safety

Results posted to the registry on 20 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydroxychloroquine	42	42
Azithromycin	43	43

Primary outcome: COVID Ordinal Outcomes Scale at 14 Days

Time frame: Assessed once on day 14 after enrollment (enrollment is day 0). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Day 14 WHO COVID Score: Hydroxychloroquine n = 42	Day 14 WHO COVID Score: Azithromycin n = 43
Value	2.0 (2.0 to 3.75)	2.0 (1.5 to 3.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Hospital discharge of the specific subject. Median length of stay for patients in both arms is 7.8 days. Upper bound of IQR for Hydroxychloroquine arm is 15.55 days and upper bound of IQR for Azithromycin arm is 20.85 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydroxychloroquine	0 of 42 (0%)	3 of 42 (7.1%)	6 of 42
Azithromycin	0 of 43 (0%)	2 of 43 (4.7%)	1 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundWHO, 2020. WHO R&D Blueprint, novel Coronavirus, COVID-19 Therapeutic Trial Synopsis. https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis
Derived from this study: PubMed 35561317Koric A, Chang CP, Mark B, Rowe K, Snyder J, Dodson M, Deshmukh VG, Newman MG, Fraser AM, Smith KR, Date AP, Gren LH, Porucznik CA, Haaland BA, Henry NL, Hashibe M. Cardiovascular disease risk in long-term breast cancer survivors: A population-based cohort study. Cancer. 2022 Jul 15;128(14):2826-2835. doi: 10.1002/cncr.34224. Epub 2022 May 13.
Derived from this study: PubMed 33166179Brown SM, Peltan I, Kumar N, Leither L, Webb BJ, Starr N, Grissom CK, Buckel WR, Srivastava R, Butler AM, Groat D, Haaland B, Ying J, Harris E, Johnson S, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with COVID-19. Results of a Randomized, Active Comparator Trial. Ann Am Thorac Soc. 2021 Apr;18(4):590-597. doi: 10.1513/AnnalsATS.202008-940OC.
Derived from this study: PubMed 32425051Brown SM, Peltan ID, Webb B, Kumar N, Starr N, Grissom C, Buckel WR, Srivastava R, Harris ES, Leither LM, Johnson SA, Paine R 3rd, Greene T. Hydroxychloroquine versus Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS). Protocol for a Pragmatic, Open-Label, Active Comparator Trial. Ann Am Thorac Soc. 2020 Aug;17(8):1008-1015. doi: 10.1513/AnnalsATS.202004-309SD.
Source for WHO COVID Ordinal Outcomes ScaleLink provided by the sponsor.
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.

Samuel M Brown, MD MS 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 2 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 20 Apr 2022. 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 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 20 Apr 2022). 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?

COVID Ordinal Outcomes Scale at 14 Days (time frame: Assessed once on day 14 after enrollment (enrollment is day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04329832, which also lists 4 linked publications.

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 20 Apr 2022.