CIGB 2020 in contacts and SARS-CoV-2 infection suspects

Phase 1

Recruiting

• Conditions: Contacts and SARS-CoV-2 infection suspects; suspected of SARS-CoV-2 infection; Coronaviridae Infections; SARS Virus; Coronavirus Infections; Betacoronavirus

• Registration Number: RPCEC00000306
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-13
• Study Completion: 2020-07-30
• Results First Posted: 2020-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.