COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab), for seriously patients.
Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action
gamma-Globulins
Anti-SARS-COV-2 gamma globulin
Sponsors
AICA Laboratorories Company
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Severe patients aged between 19 and 75 years, with a confirmed diagnosis by RT-PCR of infection by the SARS-CoV-2 virus. 2. Patients with less than 10 days of evolution since the onset of symptoms. 3. Patient who gives his informed consent.
Exclusion criteria
Exclusion criteria: 1. Ventilated 2. With acute and chronic kidney disease 3. Previous thromboembolic events 4. History of previous anaphylaxis 5. Previous history of adverse reaction to intravenous gamma globulin 6. Pregnant or lactating woman 7. Severe comorbidity: terminal cancer and severe heart disease. 8. Body Mass Index (BMI) = 30 9. With a diagnosis of selective IgA immunodeficiency 10. With autoimmune diseases 11. That they are using treatment with the anti-CD 6 monoclonal antibody Itolizumab 12. History of having received treatment with blood products one month before inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 1. Serious adverse events. Causation relationship (1. Possible, 2. Probable, 3. Definitive). Measurement time: 7 days after treatment. Exploring the Effect: 2. Antiviral and anti-inflammatory favorable response on the 7th day after the treatment The favorable response is measured if there is an increase in the Ct value, in the RT PCR and a decrease in the neutrophil/lymphocyte ratio; of C-reactive protein and D-Dimer). Measurement time: days 0, 3, 5 and 7 after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Of safety: 1. Clinical Adverse Events-AE (- Type of AE (Serious or Not serious), - Duration of the AE (Difference, in dates, between the start and end of the AE), - AE Intensity (Mild, Moderate, Severe), - Behavior regarding the treatment under study (No changes, Interruption of the treatment under study), - AE result (Recovered, Improved, Persists, Sequelae). Measurement time: 7 days after treatment administration. 2. Percentage of patients with out-of-range values in clinical laboratory variables (hemochemistry).Measurement time: Days 0, 3, 5 and 7. Of antiviral effect. 3. PCR RT (Qualitative: positive or not, and value of CTs (cycle threshold)). Measurement time: Days 0, 3, 5 and 7. Inflammatory immune response. 4. Neutrophil / lymphocyte ratio (NLR) (The values at each time and the absolute change of the final value with respect to the initial value will be described). Measurement time: Days 0, 3, 5 and 7. 5. Quantitative C-Reactive Protein (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease in the values on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7. 6. D-dimer (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7. Clinical response: 7. Imaging changes of the CT scan (Favorable: When there is a decrease in SCORE and there are no qualitative complications, whether or not it has. Stationary: When the same conditions are maintained in both variables. Unfavorable: When the SCORE is increased and / or there are qualitative complications). Measurement time: Days 0, 7. 8. Lung X-ray changes (The score on the diagnostic scale will be categorized into normal (0), mild (1-2), moderate (3-6) and severe (> 6).). Measurement time | — |
Countries
Cuba
Contacts
Public ContactBeatriz Amat Valdés
Military Hospital Dr. Luis Diaz Soto
Outcome results
None listed