COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000307-En

Iraldo Bello Rivero

iraldo.bello@cigb.edu.cu

2020-04-14

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Positivity to SARS-CoV-2 by rapid or confirmatory test of qPCR.2) ECOG functional status = 2 (Karnofsky = 70%).3) Voluntariness of the patient by signing the informed consent.

1) Patients with decompensated chronic diseases at the time of inclusion (severe arterial hypertension, ischemic heart disease, diabetes mellitus, etc.). 2) Patients with a history of autoimmune diseases. 3) Presence of hyperinflammation syndrome. 4) Serious coagulation disorders. 5) Known hypersensitivity to any of the components of the formulation under study. 6) Pregnancy or lactation. 7) Obvious mental incapacity to issue consent and act accordingly with the study.

2

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

19

100

Cuba

No restriction on type of patients

0: No restriction on type of patients

120

1) Virological evaluation: Time until the negativity of the SARS-Cov-2 RNA (absence of the virus according to the qPCR technique in real time) in positive patients after starting antiviral therapy (the percentage of patients negative for SARS will be calculated). VOC-2 by qPCR in tissue of nasopharyngeal exudate Measurement time: 48; 72 and 96 hours after starting treatment. 2) Clinical evaluation: Time to progression to severe COVID-19 (the percentage of patients who become severe will be calculated). Measurement time: 3rd week; after completion of the antiviral treatment under investigation.

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

Phase 2

[{"arm_notes": "", "treatment_id": 668, "treatment_name": "Interferon alpha gamma", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "no third arm", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}]