Systemic inflammation by Covid-19 COVID-19 SARS-CoV-2
Conditions
Interventions
- Therapeutic scheme with Jusvinza for patients with mechanical ventilation:
2 mg every 12 hours intravenously until the patient is extubated. After this, the treatment corresponding to that day is co
and decrease the neutrophil / lymphocyte ratio below 3.
Irrespective of their clinical condition, obese patients received 2 mg every 12 hours.
Peptides
Administration, Intravenous
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients older than 19 years. 2. SARS-CoV-2 positive patients in moderate, severe or critical conditions, who have been indicated for treatment with Jusvinza, in the period between March 20 and September 6, 2021.
Exclusion criteria
Exclusion criteria: Not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of high risk patients recovered. Measurement time: 7 days after treatment 2. Percentage of seriously ill patients recovered. Measurement time: 10 days after treatment 3. Percentage of critically ill patients recovered. Measurement time: 15 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical evolution (Vital signs: mean arterial pressure (mmHg), heart rate (beats/min), respiratory rate (breaths/min) and body temperature (°C); Ventilatory parameters: SO2 (%), PaO2 (mmHg) and PF). Measurement time: from the onset of symptoms to medical discharge. 2. Radiological evolution (According to the RALE score (0 to 8 points)). Measurement time: from admission to discharge. 3. Serum inflammatory biomarkers (Values of NLR, C-reactive protein, erythrocyte sedimentation, Ferritin, LDH, D-dimer, CPK, ASAT, ALAT). Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 4. Cytokines (Values of IL-6, TNFa and IL-10). Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 5. Percentage of CD4, CD8 and Treg lymphocytes. Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 6. Adverse Events-AE (Percentage of Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (Grade 1: mild, Grade 2: moderate, Grade 3: grave, Grade 4: grave, Grade 5: grave), -Causality relationship (Definite, Probable, Possible, Doubtful). -Measures have (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Interruption of the treatment under study, Extension of hospitalization), -Result (Fully resolved, Resolved with aftermath, Improved, Overrun, Worsening, Death caused by this event)). Measurement time: from the beginning of the treatment until to medical discharge. | — |
Countries
Cuba
Contacts
Public ContactMaria Dominguez Horta
Center for Genetic Engineering and Biotechnology (CGIB)
Outcome results
None listed