COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-88bjcv

Mauro Teixeira

mmtex.ufmg@gmail.com

2020-11-06

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

Be between 18 and 80 years old, weight between 50 and 100 kg, maximum of 10 days of symptoms, admission to the intensive care unit or COVID-19 unit with suspected COVID-19 pneumonia and 93% less oxygen saturation in room air, but not receiving mechanical ventilation, diagnosis of COVID-19 infection based on a viral polymerase chain reaction test, rapid test or based on symptoms associated with a consistent lung tomography, be able to provide a free consent form or have the free consent form provided by a legally designated representative.

Patients who received treatment with inhibitors of complement system factors (such as eculizumab) or treatments with therapy with biological immunomodulators (example tocilizumab, etanercept, infliximab) in the 4 weeks prior to the admission in the study, patients involved in other clinical studies, patients with active tissue or systemic bacterial or fungal infection, pregnant or breastfed patients, patients with more than ten days of symptoms.

2

Hospital Eduardo de Menezes

18

80

Brazil

Severe disease at enrollment

6: Severe disease at enrollment

0

Quantify the number of days for respiratory recovery; defined as oxygen saturation greater than 93% measured by pulse oximeter; without oxygen supplementation for at least 24 hours. If the patient achieves this goal; but is kept in the hospital for other reasons (for example; non-respiratory organ dysfunction); the goal will be considered fulfilled.;With regard to secondary outcomes; it is expected to measure the number of days without a ventilator until hospital discharge; hospitalization time; presence of recovery or death; which will be verified by telephone; what is the frequency; severity and ratio of adverse effects related to treatment; what is the frequency of adverse events that justify premature discontinuation of treatment or study; what are the changes in clinical and laboratory parameters (biochemical; hematological and urinary) between admission to the study and post-treatment.

Phase 2

[{"arm_notes": "", "treatment_id": 899, "treatment_name": "Nomacopan", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]