Prophylaxis of SARS-CoV-2 infection COVID-19 SARS-CoV2
Conditions
Interventions
- Recombinant human interferon alpha 2b (10M
Nasalferon): 1 drop (0.05 mL
500,000 IU IFN-a2b) in each nostril, twice daily (2.0 MIU daily IFN-a2b), for 10 days.
Interferon-alpha
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Individuals aged = 19 years. 2) Voluntariness of the subject by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2. 2) Treatment with immunosuppressants in the last month prior to inclusion. 3) Ongoing treatment, for any reason, with any IFN formulation. 4) Acute illnesses in the last 30 days. 5) Use of any other medication intranasally. 6) Subjects who underwent tonsillectomy. 7) History of allergic rhinitis and recurrent episodes of nasal bleeding. 8) Active chronic asthma. 9) Patients with myasthenia gravis. 10) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion. 11) Administration of an investigational drug in the 30 days prior to inclusion in the study. 12) Known hypersensitivity to thiomersal and any of the components of the formulation under study. 13) Pregnancy or breastfeeding. 14) Obvious mental incapacity to issue consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - Adverse clinical 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 (no related, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, 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 in the first 10 days (coinciding with the period of administration of the research product), and at 16 and 23 days after the start of treatment. - Pharmacodynamic activity associated with IFN alpha (The local and systemic expression of the protein 2-5 oligoadenylate synthetase 1 will be evaluated in samples of oropharyngeal scraping and peripheral blood). Measurement time: at the beginning, 24 and 72 hours, 5th day and days 16 and 23. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Antiviral protection of the individual (active surveillance of respiratory symptoms and other clinical manifestations will be carried out. The type, number, intensity and duration of symptoms will be analyzed). Measurement time: throughout the study execution period (Up to day 23). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed