COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000359-En

Francisco Hernandez Bernal

hernandez.bernal@cigb.edu.cu

2021-03-18

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1) Individuals aged between 19 and 80 years 2) Physical examination without significant alterations. 3) Voluntariness of the subject by signing the informed consent.

1) Subjects with a history of SARS-CoV-2 infection confirmed by RT-PCR or with this virological diagnosis at the time of inclusion in the study.2) Convalescent, contact or suspect of COVID-19 at the time of inclusion.3) Subjects who have received a vaccine candidate against COVID-19.4) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia.5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.6) Body mass index =18 or = 35 Kg / m2.7) Subjects with tattoos in both deltoid regions.8) Administration of any research product in the last three months.9) Subject treated in the last three months or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study.10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study.11) Known hypersensitivity to thiomersal and to any of the components of the formulation under study.12) History or suspicion of alcoholism or drug dependence.13) Pregnancy or breastfeeding. Woman of reproductive age not using contraceptives or planning pregnancy.14) Obvious mental incapacity to issue consent and act accordingly with the study.

2

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

19

80

Cuba

Healthy volunteers

N/A

48290

Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product.

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

Phase 3

[{"arm_notes": "", "treatment_id": 1975, "treatment_name": "Cigb-66", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]