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Can an old malaria drug help fight severe COVID-19?

NCT ID NCT04361461

Disease control Sponsor: Apsen Farmaceutica S.A. 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether hydroxychloroquine, given alone or with azithromycin, can improve outcomes for adults hospitalized with moderate to severe COVID-19 lung disease. Participants receive hydroxychloroquine for 10 days, and some also get azithromycin for 5 days. Researchers measure how patients respond on a WHO severity scale over 14 days, and track survival and need for mechanical ventilation.

What this could mean

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

Active substance
Hydroxychloroquine, alone or combined with azithromycin
What this could lead to
If effective, this could provide a treatment option to reduce disease severity and improve recovery in hospitalized COVID-19 patients.
What could go wrong
The trial is early and may not show a benefit. Hydroxychloroquine can cause heart rhythm problems, and combining it with azithromycin may increase that risk.

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.

Expected to start

Apr 2020

An estimate. Start dates often move.

Expected to finish

Nov 2020

An estimate. End dates often move.

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 years and older

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: * Males and females aged \> 18 years; * Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea); * Diagnosis confirmed by real-time PCR or suspected COVID-19; * Hospitalized patients with: * Moderate disease: hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%; or * Serious illness: Hospitalized patients with hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation. Exclusion Criteria: * Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia; * Liver failure or elevation of transaminases greater than 5 times; * Cardiac patients with electrocardiogram with extended QT interval; * Pregnant women; * Use in the last 30 days of hydroxychloroquine or azithromycin; * Allergy to hydroxychloroquine or azithromycin.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 lung disorder severe acute respiratory syndrome

As listed by the trial registrant

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

Coronavirus infections Pulmonary disease SARS (severe acute respiratory syndrome) SARS-CoV 2

Contacts and locations

Locations

  • Apsen Farmacêutica S.A.

    São Paulo, São Paulo, 04753-001, Brazil

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