COVID-19Phase 3OAHU-COVID19NCT04345692
A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
A Phase 3 study testing Hydroxychloroquine in people with COVID-19, run by Queen's Medical Center at 1 site in United States.
Trial summary
This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2020to 31 Aug 2020
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures. iii. Male or female adult ≥18 - 95 years of age at time of enrolment. iv. Laboratory-confirmed SARS-CoV-2 infection in any specimen < 5 days prior to randomization.
- At least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or
- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air vi. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
Who cannot join
- History of liver failure ii. History of stage 4 severe chronic kidney disease or requiring dialysis iii. Self-reported pregnant or breast feeding. iv. Allergy to hydroxychloroquine or choloroquine v. Known contraindication to hydroxychloroquine, including retinopathy, G6PD deficiency, QT prolongation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.
Read the detailed description
The overall objective is to evaluate the clinical efficacy and safety of hydroxychloroquine (HCQ) relative to standard of care among 350 hospitalized adult patients who have COVID-19.
Primary Aim i. Clinical status (on a 7-point ordinal scale) at day 15
Clinical Status 7-point ordinal scale:
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities
- Hospitalized, not requiring supplemental oxygen
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or ECMO
- Death
After enrollment and randomization there will be baseline and then daily assessments of clinical status and test results and procedures during hospitalization. Course of HCQ treatment is 5 days. Participants are followed daily during hospitalization. All procedures, evaluations and treatment, including the hydroxychloroquine laboratory tests, and radiology tests are part of the usual clinical care for COVID-19 patients. This study will only collect the information obtained as part of hospital standard of care. If the information is not available, it will not be obtained by any other mechanism. After discharge there is a follow up telephone call at day 15 and day 28. Follow-up assessment includes any clinical events, adverse events, and clinic or emergency visits or hospitalizations. Participants in the HCQ arm have safety labs: CBC and Comprehensive Metabolic profile scheduled on day 7 and 14.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine 400 mg 2x day by mouth on day 1, followed by 200 mg 2x day by mouth days 2-5 Receives: Drug: Hydroxychloroquine |
| Usual Care | No intervention | usual care for hospitalized patients diagnosed with COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
i. Clinical status
Clinical Status (on a 7-point ordinal scale) at day 15
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities
- Hospitalized, not requiring supplemental oxygen
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or ECMO
- Death
Measured: Clinical Status (on a 7-point ordinal scale) at day 15
Secondary outcomes (4)
Oxygenation
Oxygenation free days in the first 28 days Incidence and duration of new oxygen use during the study
Measured: up to day 28
Mechanical Ventilation
Ventilator free days in the first 28 days Incidence and duration of new mechanical ventilation use during hospitalization
Measured: up to day 28
Hospitalization
Duration of hospitalization (days)
Measured: up to day 28
Mortality
28-day mortality
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start26 Mar 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: RECOVERY Trial results - no efficacy
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
- Model description
- Randomized, 2 arm, open label hydroxychloroquine plus usual care compared to usual care in hospitalized patients
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Seto, MD, Principal investigator, Queen's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345692
- Sponsor's protocol ID
- RA-2020-018
- Acronym
- OAHU-COVID19
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04345692
- Acronym / sponsor ID
- OAHU-COVID19 / RA-2020-018
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: RECOVERY Trial results - no efficacy
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Queen's Medical CenterUniversity, hospital or other
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 14 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 is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.
Detailed description
The overall objective is to evaluate the clinical efficacy and safety of hydroxychloroquine (HCQ) relative to standard of care among 350 hospitalized adult patients who have COVID-19.
Primary Aim i. Clinical status (on a 7-point ordinal scale) at day 15
Clinical Status 7-point ordinal scale:
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities
- Hospitalized, not requiring supplemental oxygen
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or ECMO
- Death
After enrollment and randomization there will be baseline and then daily assessments of clinical status and test results and procedures during hospitalization. Course of HCQ treatment is 5 days. Participants are followed daily during hospitalization. All procedures, evaluations and treatment, including the hydroxychloroquine laboratory tests, and radiology tests are part of the usual clinical care for COVID-19 patients. This study will only collect the information obtained as part of hospital standard of care. If the information is not available, it will not be obtained by any other mechanism. After discharge there is a follow up telephone call at day 15 and day 28. Follow-up assessment includes any clinical events, adverse events, and clinic or emergency visits or hospitalizations. Participants in the HCQ arm have safety labs: CBC and Comprehensive Metabolic profile scheduled on day 7 and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, 2 arm, open label hydroxychloroquine plus usual care compared to usual care in hospitalized patients
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquineHydroxychloroquine 400 mg 2x day by mouth on day 1, followed by 200 mg 2x day by mouth days 2-5 |
| Usual Care | No intervention | –usual care for hospitalized patients diagnosed with COVID-19 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures. iii. Male or female adult ≥18 - 95 years of age at time of enrolment. iv. Laboratory-confirmed SARS-CoV-2 infection in any specimen < 5 days prior to randomization.
- At least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or
- Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air vi. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
Key exclusion criteria (1 listed)
- History of liver failure ii. History of stage 4 severe chronic kidney disease or requiring dialysis iii. Self-reported pregnant or breast feeding. iv. Allergy to hydroxychloroquine or choloroquine v. Known contraindication to hydroxychloroquine, including retinopathy, G6PD deficiency, QT prolongation
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 |
|---|---|---|
| HydroxychloroquineAlso: Plaqueniloral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet | Drug | Hydroxychloroquine |
Primary outcome
i. Clinical status
Time frame: Clinical Status (on a 7-point ordinal scale) at day 15
Clinical Status (on a 7-point ordinal scale) at day 15 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
4 secondary outcomes
Oxygenation
Time frame: up to day 28
Mechanical Ventilation
Time frame: up to day 28
Hospitalization
Time frame: up to day 28
Mortality
Time frame: up to day 28
Results and safety
The study was stopped early (reason given: RECOVERY Trial results - no efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Todd Seto, MD principal investigator
Queen's Medical Center
1 site 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 in people with COVID-19, run by Queen's Medical Center at 1 site 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 1 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: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: RECOVERY Trial results - no efficacy). Results are not available in the source record.
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?
i. Clinical status (time frame: Clinical Status (on a 7-point ordinal scale) at day 15). 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 6 Feb 2026.