COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04361461

Fernanda Martinez, B.Sc.

fernanda.martinez@apsen.com.br

2020-04-24

Withdrawn

RCT

Randomized

Parallel

Open label

single-center

Treatment

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.

- 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.

2

Apsen Farmaceutica S.A.

18

None

Brazil

Severe disease at enrollment

6: Severe disease at enrollment

0

Individual response rate

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]