None listed
Conditions
Interventions
A 200 ml unit of COVID 19 convalescent donor s plasma will be transfused considering ABO and Rh compatibility through an intravenous line up to 2 times spaced 24 hours apart.
Sponsors
Marina de Guerra del Peru,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients over 18 years of age from both sexes hospitalized at the Centro Medico Naval. • Be in the disposition and capacity to give free and informed consent, or have a relative or tutor with the capacity to do so (Appendix 2) • Be in the disposition and capacity to undergo clinical evaluations and diagnosis procedures. • Previous COVID-19 diagnosis supported by a laboratory test (PCR-RT or by the presence of SARS-CoV-2 antibodies). • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria during a span of less than 10 days. • Need of mechanical ventilation or continuous oxygenation at positive pressure.
Exclusion criteria
Exclusion criteria: • Diagnosis of Mild Acute Respiratory Distress Syndrome according to the definition of the Berlin criteria. • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria, lasting more than 10 days. • Demonstrated hypersensitivity or history of allergy to blood products or immunoglobulins. • Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It is defined as an event of death due to the 2019 Coronavirus disease or another cause that occurred between the start of treatment until day 60. Measure:Mortality Timepoints:60 days from the first day of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time in days of use of mechanically ventilated breathing support for each study group (Experimental and Control), this measurement will be performed at the end of the study and until the last enlisted participant is monitored for 60 days of follow-up Measure:Time use of mechanical ventilation Timepoints:60 days from the first day of treatment. ; Outcome name:Percentage of participants who had serious adverse events related to convalescing plasma transfusion for each study group (Experimental and Control), this measure will be performed at the end of the study and up to the completion of the last 60 days of follow-up to the last enlisted participant. Measure:Serious adverse events Timepoints:60 days from the first day of treatment. ; Outcome name:Time in days of use of respiratory support with High Flow Cannula for each study group (Experimental and Control), this measurement will be performed at the end of the study and up to the last enlisted participant to complete the 60 days of follow-up. Measure:Time of use High flow Time Timepoints:60 days from the first day of treatment. ; Outcome name:Time in days of the need for respiratory support with any type of oxygen therapy for each group of the study (Experimental and control), this measure will be performed at the end of the study and until the last enlisted participant is monitored for the last 60 days of follow-up Measure:Supplemental Oxygen Dependence Time Timepoints:60 days from the first day of treatment. ; Outcome name:Time in hospitalization days for each study group (Experimental and Control), this measure will be performed at the end of the study and up to the last enlisted participant to complete the 60 days of follow-up. Measure:Length of hospital stay. Timepoints:60 days from the first day of treatment. | — |
Countries
Peru
Contacts
Public ContactMario Ortiz
Marina de Guerra del Peru
Outcome results
None listed