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NCT Number: NCT04361461

Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (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.

Why the study stopped: This study was canceled before enrollment due to a decision by the Sponsor
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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxychloroquine Sulfate

Drug

400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.

Other names: Reuquinol®

Hydroxychloroquine Sulfate + Azythromycin

Drug

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.

Other names: Reuquinol® + Azythromycin

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: 28 days after randomization

    All-cause mortality rates at Day 28th after randomization

  2. Duration of mechanical ventilation

    Time frame: baseline

    Number of days that the patient was on mechanical ventilation which was under ventilation from basal line

  3. Proportion of patients which needed mechanical ventilation during study

    Time frame: hospitalization within 28 days

    Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.

  4. World Health Organization (WHO) Ordinal scale

    Time frame: 28 days after inclusion and compared to baseline

    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.

  5. Duration of hospitalization

    Time frame: hospitalization within 28 days

    Length of hospital stay in days for hospitalization

  6. Rates of drug discontinuation

    Time frame: hospitalization within 28 days

    Rates of drug discontinuation in all causes under study

Other outcomes

  1. Rates of serious adverse events

    Time frame: Day 14th

    Rates of serious adverse events

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Collaborators

  • Federal University of São Paulo

Registry information

Official study title

Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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