COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000306-En

Zurina Cinza Estevez

zurina.cinza@cigb.edu.cu

2020-04-13

Recruiting

RCT

Randomized

Parallel

Open label

unclear

Prevention

1- Age equal to or greater than 60 years, of both sexes. 2- Cases defined as contact or suspected of SARS-CoV-2 infection. 3- Voluntary nature of the subject to participate expressed through the delivery of signed informed consent.

1-Established lung disease, pneumonia defined by imaging. 2- Serious evolution of SARS-CoV-2 infection (extrapulmonary systemic hyperinflammation syndrome). 3- AST or ALT> 2 times normal value. 4- Abnormal bilirubin (total bilirubin> 1.2 mg / dL, direct bilirubin> 0.4 mg / dL). 5- Creatinine> 2.0 mg / dl. 6- Use of immunosuppressive drugs within 1 month of recruitment, or chemotherapy. 7- Hemoglobin <10 g / dl. 8- Platelets <100,000 / ml. 9- History of allergy to any of the ingredients of the vaccine under study. 10- Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or to monitor the patient.

2

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

60

100

Cuba

Close contacts to covid patients

N/A

80

Activation of markers of the innate immune system (in oropharyngeal scraping: relative concentration of dendritic cells; phenotypic analysis of leukocyte cells; transcriptional analysis of elements of molecules related to the immune response with expression at the level of epithelium and infiltrating leukocytes; quantification by ELISA of cytokines related to systemic inflammation such as IL-6; TNF alpha; IFN alpha and gamma; among other mediators of systemic inflammation; etc.). Measurement time: at baseline and; on days 4 and 8 post-treatment.

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

Phase 1/Phase 2

[{"arm_notes": "", "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"}]