COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8jyhxh

Renê Oliveira

rdroliveira@hcrp.usp.br

2020-07-30

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Moderate or severe forms of COVID-19, 18 years or older, body weight of 50 kg or more, serum Ca2+ and K+ normal, QT interval lower than 450 ms at 12 derivations electrocardiogram, beta-HCG (serum or urine) negative (if woman under 50).

Mild and critical forms of COVID-19, allergy to any of the medications under study, diagnosis of porphyria, myasthenia gravis or uncontrolled arrhythmia at admission, pregnancy, use of digoxin, amiodarone, verapamil or metoprolol, use of protease inhibitors, history of chronic liver disease with liver dysfunction, unable to understand the information contained in the Consent Form.

2

Hospital das Clínicas de Ribeirão Preto

18

100

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

To evaluate the duration of oxygen therapy for both groups; measured in number of days of need of supplemental oxygen by catheter or masks.;To evaluate the hospitalization time for both groups; measured in number of days from the admission to the discharge.;To evaluate the percentage of individuals who will require admission to the Intensive Care Unit; due to clinical deterioration. In this situation; due to institutional restriction; the study drugs will be discontinued.;To evaluate the percentage of death.

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1455, "treatment_name": "Chloroquine+colchicine", "treatment_type": "Antimalarials+metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}]