RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF PLASMA FROM CONVALESCENT PATIENTS WITH THE NEW CORONAVIRUS DISEASE (COVID-19) FOR THE EXPERIMENTAL TREATMENT OF PATIENTS HOSPITALIZED IN THE CENTRO MEDICO NAVAL "CIRUJANO MAYOR SANTIAGO TAVARA" "

Authors
Category Primary study
Registry of TrialsClinical Trials Peruvian Registry
Year 2020
INTERVENTION: Group name:Experimental Type of group;1 N° of participants:100 Intervention(s) description: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. CONDITION: ‐B342 Coronavirus infection, unspecified site ; Coronavirus infection, unspecified site B342 Coronavirus infection, unspecified site PRIMARY OUTCOME: 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 OUTCOME: 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 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 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: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 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. 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.
Epistemonikos ID: dfa8516ae38d0a1e28a19e2487d0b2e9ff114799
First added on: Oct 09, 2020