COVID-19 COVID-19 SARS-CoV-2
Conditions
Interventions
Group 1, Nasalferon 5M (experimental): Recombinant human interferon alpha 2b solution for nasal administration (Nasalferon) of 5 million international units per milliliter (MIU/mL) in doses of one dro
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health (MINSAP)
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Virological diagnosis by RT-PCR of infection with SARS-CoV-2. 2. Age between 19 and 80 years, without distinction of sex or skin color. 3. Mild stage COVID-19 patients. 4. Time no longer than 48 hours from the onset of clinical respiratory symptoms. 5. Informed consent of the patient or legal representative
Exclusion criteria
Exclusion criteria: 1. Individual with PCR positive for SARS-CoV-2 without having started treatment within 48 hours after the onset of symptoms. 2. Individuals under the age of 19 and over the age of 80. 3. Individuals with COVID-19 in moderate, severe or critical stage. 4. Individuals with decompensated chronic disease. 5. Immunosuppressant treatment in the last month prior to enrollment. 6. Ongoing treatment, for any cause, with any IFN formulation. 7. Use of any other medication or substance intranasally. 8. Patients with myasthenia gravis. 9. Administration of an investigational drug in the 30 days prior to inclusion in the study. 10. Individuals with hypersensitivity to thiomersal (thimerosal). 11. Individuals with hypersensitivity to interferon alpha. 12. Obvious mental incapacity to give consent and act accordingly with the study. 13. Pregnancy, puerperium or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovered patient (SARS-CoV-2 PCR negative in the absence of major symptoms of upper respiratory infection). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Speed of response to treatment (Moment of first negative PCR during treatment). Measurement time: on the 3rd day, 5th day, 7th day and 9th day after starting the treatment. 2. Proportion of patients recovered (ratio of number of patients recovered / number of patients included). Measurement time: at hospital discharge. 3. Severity of the disease (Duration and intensity of COVID-19 symptoms). Measurement time: daily during the time of hospitalization of the patient. | — |
Countries
Cuba
Contacts
Public ContactHugo Nodarse Cuni
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed