COVID-19 infection COVID-19
Conditions
Interventions
Administration of one to four bags (300 ml) of plasma by intravenous route the days 1, 3, 7 and 12.
Plasma
Administration, Intravenous
Sponsors
Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”
Eligibility
Sex/Gender
All
Age
19 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Adult with SARS-CoV2 infection diagnosed by RT-PCR. 2. Remain asymptomatic with SARS-CoV2 positive PCR for more than 30 days. 3. That the antibody kit tests do not detect antibodies. 4. That there is no history of anaphylaxis reactions with blood products. 5. That at the clinical evaluation by the attending physician there are no contraindications for plasma transfusion. 6. That the patient or their relatives give their informed consent to receive this donation.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement of the respiratory failure (It will measure as an increase in the partial pressure of oxygen above 60 mmHg or oxygen saturation greater than 90.7%). Measurement time: 48 hours after treatment 2. Clinical improvement (It will measure through the change in the classification from Severe to From Care and From Care to Open Room). Measurement time: 72 hours after treatment 3. Improvement of at least two complete blood count parameters (It will measure as any positive difference in Hemoglobin levels, differential white blood cell count and platelet value). Measurement time: 48 and, 72 hours after treatment 4. Negativization of the PCR (Yes, No). Measurement time: 7 days after the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events-AE (Occurrence of any AE in the subject (Yes, No), Type of AE (Name of the adverse event), Location (Local, Systemic), Time of onset (Immediate, Late), Duration of AE (Less than a day, Greater than a day), Previous knowledge (Expected, Unexpected), AEs intensity (Mild, Moderate, Severe), AEs severity (Serious, Not serious), AEs result (Recovered, Improved, Persists, Sequelae), Causal relationship (Very Probable, Probable, Possible, Unlikely, Not related, Not evaluable), Outcome of the AE (Recovered, Not Recovered, Recovered with sequelae, Death, Unknown), Attitude towards treatment of study (Continuation, Definitive interruption). Measurement time: At the end of treatment | — |
Countries
Cuba
Contacts
Public ContactConsuelo Macias Abraham
Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”
Outcome results
None listed