COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000330-En

Eduardo Ferat Osorio

eduardoferat@me.com

2020-08-11

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Patients aged = 18 years.2) Virological diagnosis by RT-PCR of infection to SARS-CoV-2.3) Patients in serious or critical condition.4) Acute respiratory failure according to clinical and Berlin criteria (imaging and oxygenation).5) Voluntariness of the patient through informed consent.

1) Previous treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6, IL-1 inhibitor (Anakinra). 2) Patients with kidney disease on hemodialysis. 3) Patients who previously indicate NO intubation, NO resuscitation. 4) Known hypersensitivity to any of the components of the formulations under study. 5) Pregnancy or breastfeeding.

2

Center for Genetic Engineering and Biotechnology (CIGB); in Havana

18

100

Mexico

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

60

1) Mortality on discharge from the Hospital (Proportion of patients who die (global and by strata: serious and critical) according to their causes and treatment groups; during their stay at the CMN Siglo XXI Specialty Hospital). Measurement time: during hospital stay. 2) Need for invasive mechanical ventilation (orotracheal intubation) in critically ill patients and; time (in days) from intubation to weaning in critically ill (if applicable) and critical patients. Measurement time: During the stay in the COVID-19 internment area; until ventilatory weaning.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 287, "treatment_name": "Cigb-258", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]