Coronavirus InfectionsPhase 3NCT04361461
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
A Phase 3 study testing Hydroxychloroquine Sulfate and Hydroxychloroquine Sulfate + Azythromycin in people with Coronavirus Infections and SARS-CoV 2, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections, SARS-CoV 2, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Hydroxychloroquine Sulfate and Hydroxychloroquine Sulfate + Azythromycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2020to 4 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
- Conditions
- Coronavirus Infections, SARS-CoV 2, SARS (Severe Acute Respiratory Syndrome), Pulmonary Disease
- Being tested
- Hydroxychloroquine Sulfate, Hydroxychloroquine Sulfate + Azythromycin
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine SulfateDrug
Also called Reuquinol®
400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
Hydroxychloroquine Sulfate + AzythromycinDrug
Also called Reuquinol® + Azythromycin
400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Hydroxychloroquine (400 mg) Receives: Drug: Hydroxychloroquine Sulfate |
| Group 2 | Experimental | Hydroxychloroquine (400 mg) + azithromycin (500 mg) Receives: Drug: Hydroxychloroquine Sulfate + Azythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual response rate
The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
Measured: 14 days after randomization
Secondary outcomes (6)
All-cause mortality
All-cause mortality rates at Day 28th after randomization
Measured: 28 days after randomization
Duration of mechanical ventilation
Number of days that the patient was on mechanical ventilation which was under ventilation from basal line
Measured: baseline
Proportion of patients which needed mechanical ventilation during study
Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.
Measured: hospitalization within 28 days
World Health Organization (WHO) Ordinal scale
The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measured: 28 days after inclusion and compared to baseline
Duration of hospitalization
Length of hospital stay in days for hospitalization
Measured: hospitalization within 28 days
Rates of drug discontinuation
Rates of drug discontinuation in all causes under study
Measured: hospitalization within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 Apr 2020 (estimated)
- Primary completion4 Nov 2020 (estimated)
- Study completion4 Nov 2020 (estimated)
Why it stopped: This study was canceled before enrollment due to a decision by the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361461
- Sponsor's protocol ID
- APS000/2020
- Status last verified
- Jun 2020
- First submitted
- 22 Apr 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04361461
- Acronym / sponsor ID
- APS000/2020
- Conditions
- Coronavirus Infections, SARS-CoV 2, SARS (Severe Acute Respiratory Syndrome), Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was canceled before enrollment due to a decision by the Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Federal University of São Paulo
- Study start
- 30 Apr 2020 (estimated)
- Primary completion
- 4 Nov 2020 (estimated)
- Study completion
- 4 Nov 2020 (estimated)
- First posted
- 24 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.
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Hydroxychloroquine SulfateHydroxychloroquine (400 mg) |
| Group 2 | Experimental | Drug: Hydroxychloroquine Sulfate + AzythromycinHydroxychloroquine (400 mg) + azithromycin (500 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| Hydroxychloroquine SulfateAlso: Reuquinol®400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days. | Drug | Group 1 |
| Hydroxychloroquine Sulfate + AzythromycinAlso: Reuquinol® + Azythromycin400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days. | Drug | Group 2 |
Primary outcome
Individual response rate
Time frame: 14 days after randomization
The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
6 secondary outcomes
All-cause mortality
Time frame: 28 days after randomization
Duration of mechanical ventilation
Time frame: baseline
Proportion of patients which needed mechanical ventilation during study
Time frame: hospitalization within 28 days
World Health Organization (WHO) Ordinal scale
Time frame: 28 days after inclusion and compared to baseline
Duration of hospitalization
Time frame: hospitalization within 28 days
Rates of drug discontinuation
Time frame: hospitalization within 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sulfate and Hydroxychloroquine Sulfate + Azythromycin in people with Coronavirus Infections and SARS-CoV 2, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Sep 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 Brazil. 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 withdrawn before enrolling participants, so there are no results.
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?
Individual response rate (time frame: 14 days after randomization). 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 8 Sep 2026.