Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
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| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Individual response rate [14 days after randomization]
The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
Secondary Outcome Measures
- All-cause mortality [28 days after randomization]
All-cause mortality rates at Day 28th after randomization
- Duration of mechanical ventilation [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 [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 [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 [hospitalization within 28 days]
Length of hospital stay in days for hospitalization
- Rates of drug discontinuation [hospitalization within 28 days]
Rates of drug discontinuation in all causes under study
Other Outcome Measures
- Rates of serious adverse events [Day 14th]
Rates of serious adverse events
Eligibility Criteria
Criteria
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);
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Diagnosis confirmed by real-time PCR or suspected COVID-19;
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Hospitalized patients with:
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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:
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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;
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Liver failure or elevation of transaminases greater than 5 times;
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Cardiac patients with electrocardiogram with extended QT interval;
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Pregnant women;
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Use in the last 30 days of hydroxychloroquine or azithromycin;
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Allergy to hydroxychloroquine or azithromycin.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Apsen Farmacêutica S.A. | São Paulo | Brazil | 04753-001 |
Sponsors and Collaborators
- Apsen Farmaceutica S.A.
- Federal University of São Paulo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APS000/2020