Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04361461|
Recruitment Status : Withdrawn (This study was canceled before enrollment due to a decision by the Sponsor)
First Posted : April 24, 2020
Last Update Posted : November 19, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infections SARS-CoV 2 SARS (Severe Acute Respiratory Syndrome) Pulmonary Disease||Drug: Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate + Azythromycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)|
|Estimated Study Start Date :||April 30, 2020|
|Estimated Primary Completion Date :||November 4, 2020|
|Estimated Study Completion Date :||November 4, 2020|
Experimental: Group 1
Hydroxychloroquine (400 mg)
Drug: Hydroxychloroquine Sulfate
400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
Other Name: Reuquinol®
Experimental: Group 2
Hydroxychloroquine (400 mg) + azithromycin (500 mg)
Drug: Hydroxychloroquine Sulfate + 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.
Other Name: Reuquinol® + Azythromycin
- 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.
- All-cause mortality [ Time Frame: 28 days after randomization ]All-cause mortality rates at Day 28th after randomization
- Duration of mechanical ventilation [ Time Frame: baseline ]Number of days that the patient was on mechanical ventilation which was under ventilation from basal line
- 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.
- 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.
- Duration of hospitalization [ Time Frame: hospitalization within 28 days ]Length of hospital stay in days for hospitalization
- Rates of drug discontinuation [ Time Frame: hospitalization within 28 days ]Rates of drug discontinuation in all causes under study
- Rates of serious adverse events [ Time Frame: Day 14th ]Rates of serious adverse events
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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%;
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361461
|Apsen Farmacêutica S.A.|
|São Paulo, Brazil, 04753-001|
|Responsible Party:||Apsen Farmaceutica S.A.|
|Other Study ID Numbers:||
|First Posted:||April 24, 2020 Key Record Dates|
|Last Update Posted:||November 19, 2020|
|Last Verified:||June 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Severe Acute Respiratory Syndrome
Respiratory Tract Diseases
RNA Virus Infections
Respiratory Tract Infections
Molecular Mechanisms of Pharmacological Action