Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome. The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease. The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation \>93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Admistration of one unit of convalescent plasma
Hospital Álvaro Cunqueiro
Vigo, Spain
Requirement for oxygen therapy to maintain saturation >93%
Proportion of patients that need oxygen to achieve a saturation \>93%
Time frame: Day 14
Safety of the treatment with CP
Safety of CP treatment was evaluated by the appearance of any adverse event related to the infusion
Time frame: Day 1
Evolution of COVID-19 symptoms
Proportion of patients with 1+2 WHO progression scale. This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. 1. = Not hospitalized without limitation in activity (no symptoms) 2. = Not hospitalized with limitation in activity (continued symptoms) 3. = Hospitalized not on supplemental oxygen 4. = Hospitalized on supplemental oxygen by mask or nasal prongs 5. = Hospitalized on non-invasive ventilation or high flow nasal cannula 6. = Hospitalized, intubated and mechanically ventilated 7. = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 8. = Death
Time frame: Day 14 and 28
Requirement for hospitalization due to worsening of symptoms
Worsening of symptoms was evaluated using the WHO progression scale 1. = Not hospitalized without limitation in activity (no symptoms) 2. = Not hospitalized with limitation in activity (continued symptoms) 3. = Hospitalized not on supplemental oxygen 4. = Hospitalized on supplemental oxygen by mask or nasal prongs 5. = Hospitalized on non-invasive ventilation or high flow nasal cannula 6. = Hospitalized, intubated and mechanically ventilated 7. = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 8. = Death
Time frame: Until day 28
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