Status:
WITHDRAWN
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Lead Sponsor:
Apsen Farmaceutica S.A.
Collaborating Sponsors:
Federal University of São Paulo
Conditions:
Coronavirus Infections
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 conti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04361461
Start Date
April 30 2020
End Date
November 4 2020
Last Update
November 19 2020
Active Locations (1)
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1
Apsen Farmacêutica S.A.
São Paulo, Brazil, 04753-001