Confirmed patients to COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group I (experimental): Treatment with CIGB 300 at the dose of 2.5 mg / kg, intravenously, daily for 5 days + treatment established in the national action protocol for COVID-19.
Group II (control): Tr
Peptides
Administration, Intravenous
CIGB 300
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) Patients who meet the diagnostic criteria for COVID 19 in categories 1 through 4 of the NIH guidelines. 2) Age over 18 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 possibility of giving their informed consent or collaborating in the trial. 4) Critical illness, category 5 of the NIH Guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the time to the negativization of the coronavirus detection test (time to the negative of the coronavirus detection test by PCR-RT in the nasopharynx). Measurement time: 48 hours and on the 7th day after starting the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical response to treatment according to the patient's condition at the time of inclusion (defined according to the NIH Guidelines): the improvement of the clinical status of the treated patients and non-progression to a serious or critical condition of the disease will be evaluated, and death. Measurement time: Daily during the patient's hospital stay (7 days). 2) Biological markers predictive of response to CIGB 300 (plasma HMGB-1 levels and 45S and CD 47 levels by real-time PCR of RNA obtained from peripheral blood mononuclear cells). Measurement time: before treatment and 6 hours after the 5th administration. 3) Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (event name), -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 (7 days). | — |
Countries
Cuba
Contacts
Public ContactIdania Baladron Castrillo
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed