ABDALA Clinical Study

Phase 1

• Conditions: COVID-19; SARS-CoV2; Disease Prevention; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000346
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-26
• Study Completion: 2021-06-30
• Results First Posted: 2021-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Individuals aged between 19 and 54 years, both inclusive (for phase I) and between 19 and 80 years old, both inclusive (for phase II).
2) Physical examination without significant alterations.
3) Hematological and blood chemistry determinations within or outside normal ranges, without clinical relevance (only for phase I).
4) Voluntariness of the subject by signing the informed consent.

Exclusion Criteria

1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2.
2) Contact or suspect of COVID-19 at the time of inclusion.
3) Subjects at high risk of exposure to SARS-CoV-2 infection (contacts of confirmed cases, health workers in the 1st line of medical care [Emergency, ICU, other risk areas]).
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 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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified