patients infected with the SARS-CoV-2 coronavirus. covid-19
Conditions
Interventions
Group A: HeberFERON (Recombinant Interferon Alpha Gamma, 3.5 MUI), subcutaneously, twice a week for three consecutive weeks.
Group B (Control): Heberon Alfa R (Recombinant Interferon alfa 2b, 3.0 MUI)
Interferon-alpha
Injections, Subcutaneous
Chloroquine
Azithromycin
HeberFERON
Kaletra
Rocephin
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) Positivity to SARS-CoV-2 by rapid or confirmatory test of qPCR. 2) ECOG functional status = 2 (Karnofsky = 70%). 3) Voluntariness of the patient by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with decompensated chronic diseases at the time of inclusion (severe arterial hypertension, ischemic heart disease, diabetes mellitus, etc.). 2) Patients with a history of autoimmune diseases. 3) Presence of hyperinflammation syndrome. 4) Serious coagulation disorders. 5) Known hypersensitivity to any of the components of the formulation under study. 6) Pregnancy or lactation. 7) Obvious mental incapacity to issue consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Virological evaluation: Time until the negativity of the SARS-Cov-2 RNA (absence of the virus according to the qPCR technique in real time) in positive patients after starting antiviral therapy (the percentage of patients negative for SARS will be calculated). VOC-2 by qPCR in tissue of nasopharyngeal exudate Measurement time: 48, 72 and 96 hours after starting treatment. 2) Clinical evaluation: Time to progression to severe COVID-19 (the percentage of patients who become severe will be calculated). Measurement time: 3rd week, after completion of the antiviral treatment under investigation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Patients with unfavorable evolution (percentage of severe through clinical evaluations [fever, cough, dyspnea, etc.] and imaging (interstitial pneumonia by X-rays]). Measurement time: During the entire period of the study (three weeks). 2) Increase in the levels of markers (at the RNA and serum levels) of response to IFNs (2-5OAS, Neopterin, ß-2 microglobulin, Mx protein). The average value of the serum concentration measured by quantitative ELISA of 2´-5´OAS and Neopterin will be calculated. Measurement time: before starting treatment, and 7 and 14 days after starting treatment. 3) Increased activation of the immune system (MHC-I / II expression, NK cells, cytotoxic T cells, macrophage activation). The percentage of activated cells will be calculated from the total number of patients who will receive treatment. Measurement time: before starting treatment, and 14 days after treatment. 4) Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (name of the event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures taken (None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event). Measurement time: daily throughout the study period (three weeks). | — |
Countries
Cuba
Contacts
Public ContactIraldo Bello Rivero
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed