COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000317-En

Idania Baladron Castrillo

idania.baladron@cigb.edu.cu

2020-05-28

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Patients who meet the diagnostic criteria for COVID 19 in categories 1 through 4 of the NIH guidelines. 2) Age over 18 years. 3) Voluntariness of the patient by signing the informed consent.

1) Pregnancy or lactation at the time of inclusion in the study. 2) Patients included in another clinical trial. 3) Diseases that compromise the patient's state of consciousness or their possibility of giving their informed consent or collaborating in the trial. 4) Critical illness, category 5 of the NIH Guidelines.

2

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

19

100

Cuba

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

20

Reduction of the time to the negativization of the coronavirus detection test (time to the negative of the coronavirus detection test by PCR-RT in the nasopharynx). Measurement time: 48 hours and on the 7th day after starting the treatment.

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

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 288, "treatment_name": "Cigb 300", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]