COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group I (experimental): Treatment with CIGB 2020 nasal spray: on days 1 and 7 and sublingual CIGB2020: daily during 7 days. The dose for both routes of administration (100 µg HBsAg + 100 µg HBcAg / 1
Immunotherapy, Active
Administration, Intranasal
CIGB 2020
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Asymptomatic or mild symptomatic Sars Cov 2 PCR-positive patients (Clinical Categories 1 and 2 of the NIH classification). 2) Age over 35 years. 3) Voluntariness of the patient by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnancy or lactation at the time of inclusion in the study. 2) Patients included in another clinical trial. 3) Diseases that compromise the patient's state of consciousness or their ability to give informed consent or collaborate in the trial. 4) Moderate, severe or critical stage (3, 4 and 5) of the NIH classification. 5) Anatomical, functional or psychological conditions that prevent the nasal or sublingual application of the Produ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response (It will assess to a) No progression to Symptomatic State or higher of the disease in Asymptomatic patients and, b) No progression to a higher state of the disease (Moderate, Severe Pneumonia) and Resolution of symptoms in mild symptomatic patients). Measurement time: Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Immunogenicity (It will assess to a) specific anti-RBD IgG antibodies (geometric mean ) b) Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that = 2 times the initial determination of the antibody titer) Time measurement: on days 9 (48 hours after treatment), at 3 and 6 months. 2) Time to achieve virological response according to PCR Ex Nasopharyngeal (Time elapsed from the first positive PCR to the first negative PCR, (It will assess to a) geometric mean in both treatment groups.b) Proportion of patients with negative PCR). Measurement time: day 8 (48 hours after treatment) 3) Clinical Adverse Events (AE). They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Causality relationship (not related, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: daily throughout the study execution period (7 days). | — |
Countries
Cuba
Contacts
Public ContactPablo Diaz Reyes
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed