Contacts and SARS-CoV-2 infection suspects suspected of SARS-CoV-2 infection
Conditions
Interventions
- Control Group: Conventional treatment
Basic (conventional) treatment planned in the hospital for the management of contacts and suspects of SARS-CoV-2 infection.
- Experimental Group: Conventional
Immunotherapy, Active
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with appearance of the SARS-CoV-2 virus (by PCR-RT). Measurement time: Sometime during the 14-day follow-up. Percentage of patients with changes in the immune response: 1) Serum cytokine pattern (variable to verify aggravation); 2) Proportion of dendritic cells of the total (Cytology, FACs); 3) Ratio of activation of dendritic cells, NK and monocytes / macrophages by cytometry (activation markers, HLA DR and costimulatory factors by RT PCR); 4) Gene expression of TLR agonists in whole blood by RT-PCR; 5) Characterization of cellular subpopulations and senescence markers. Measurement time: bat baseline and, on days 4 and 8 post-treatment. Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (name of the event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, Definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event). Measurement time: daily throughout the follow-up of the subjects. Laboratory (numerical values ??of Blood chemistry test: hemogram, hematocrit, leukogram with differential, platelet count, prothrombin time, C-reactive protein, ALAT, ASAT, glycemia, creatinine, cholesterol, triglycerides, albumin and bilirubin). Measurement time: at baseline and, on days 4 and 8 post-treatment. | — |
Countries
Cuba
Contacts
Public ContactZurina Cinza Estevez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed