COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000353-En

Pablo Diaz Reyes

pablo.dias@cigb.edu.cu

2021-03-01

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

1) Asymptomatic or mild symptomatic Sars Cov 2 PCR-positive patients (Clinical Categories 1 and 2 of the NIH classification). 2) Age over 35 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 ability to give informed consent or collaborate in the trial. 4) Moderate, severe or critical stage (3, 4 and 5) of the NIH classification. 5) Anatomical, functional or psychological conditions that prevent the nasal or sublingual application of the Produ

2

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

35

100

Cuba

Mild disease at enrollment

1: Mild disease at enrollment

354

Clinical Response (It will assess to a) No progression to Symptomatic State or higher of the disease in Asymptomatic patients and; b) No progression to a higher state of the disease (Moderate; Severe Pneumonia) and Resolution of symptoms in mild symptomatic patients). Measurement time: Day 7.

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

Phase 2/Phase 3

[{"arm_notes": "nasal spray: on days 1 and 7 and sublingual", "treatment_id": 285, "treatment_name": "Cigb 2020", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]