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Hydroxychloroquine trial for COVID-19 fizzles out

NCT ID NCT04333654

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase study tested whether hydroxychloroquine, a drug used for malaria and autoimmune diseases, could reduce the amount of virus in adults with mild COVID-19 not needing oxygen. Only 8 people took part before the trial was stopped early. The study was too small to draw any meaningful conclusions about the drug's effect.

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 treatment to reduce the amount of virus in people with mild COVID-19.
What could go wrong
This was a very small, early-phase trial that was terminated early, so results are not reliable. Hydroxychloroquine has not been proven effective for COVID-19 and can have serious side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Apr 2020

Finished

May 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 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 : * Participants with diagnosis of COVID-19 via an approved or authorized molecular test * Presence of symptoms compatible with COVID-19 at the time of screening * Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less * Female participants must use an acceptable birth control method, as specified by each site and country Exclusion criteria: * COVID-19 disease requiring the use of supplemental oxygen * Electrocardiogram (ECG) tracing with QTc interval \> 450 ms for men, \> 470 ms for women (Fridericia algorithm recommended) * Bradycardia (\< 50 beats/min) * History of cardiac disease (eg. congestive heart failure, myocardial infarction) * History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Women who are pregnant or breastfeeding * Concurrent antimicrobial therapy * Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds * Hydroxychloroquine use within 2 months before enrollment * History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis * History of retinopathy * History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death * History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19

As listed by the trial registrant

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

Coronavirus infection

Contacts and locations

Locations

  • Investigational Site Number 0561001

    Brussels, BE-1200, Belgium

  • Investigational Site Number 0561002

    Lodelinsart, 6042, Belgium

  • Investigational Site Number 2501001

    Bordeaux, 33076, France

  • Investigational Site Number 2501002

    Paris, 75005, France

  • Investigational Site Number 5281001

    Groningen, 9728 NZ, Netherlands

  • Investigational Site Number 5281002

    Harderwijk, 3844 DG, Netherlands

  • Investigational Site Number 8400001

    Boston, Massachusetts, 02115, United States

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