COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-9d8z6m

Alexandre;Fernando Cavalcanti;Zampieri

abiasi@hcor.com.br; fzampieri@hcor.com.br

2020-03-27

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

Patients admitted to the ICU or Hospital with suspected or confirmed COVID-19

Presence of any of the following: Need to supplement oxygen more than 4L, Use of high flow nasal catheter, Use of non-invasive ventilation, Use of mechanical ventilation, Use of hidroxichoroquine, chloroquine, azithromycin or other macrolide over 24 hours, History of severe ventricular or QTC equal or grater than 48 ms cardiac arrithmia, History of hepatic desease (cirrosis), Renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30ml/min/1.73m2, using MDRD or CKD-EPI method), Patients with retinopathy or macular degeneration, Children under 18 years,Pregnancy, Allergy to chloroquine and derivatives, Allergy to azythromicyn, Patients in hospital over 48hr, Patients with symptoms over 14 days

3

Hospital do Coração

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

630

Evaluate patient's health condition after 15 days. The primary outcome is based on seven possible patient's health conditions whithin 15 days:;Outpatient; without activity limitation;Patient in hospital; without supplemental oxygen;Patient in hospital; with supplemental oxygen;Patient in hospital with non-invasive ventilation or high flow cannula;Patient in mechanical ventilation;Death;Outpatient; with limited activities

Phase 3

[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]