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Hydroxychloroquine COVID trial fizzles: only 17 patients enrolled

NCT ID NCT04345692

Disease control Sponsor: Queen's Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether hydroxychloroquine (a malaria drug) could help hospitalized COVID-19 patients recover faster. It planned to enroll 350 people but was stopped early with just 17 participants. Because it ended so early, we cannot say whether the drug works or is safe for this use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine (Plaquenil)
What this could lead to
If it had worked, this could have pointed toward a cheap, widely available treatment for hospitalized COVID-19 patients.
What could go wrong
The trial was terminated early with only 17 participants, far short of the planned 350. Results are too limited to draw any conclusions, and earlier studies showed mixed or no benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

17 people

The number who actually took part.

Started

Mar 2020

Finished

Aug 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: i. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. ii. 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. v. At least one of the following: 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or 2. 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. Exclusion Criteria: i. 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

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19

Contacts and locations

Locations

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.