Hospital Álvaro Cunqueiro
Vigo, 36211, Spain
NCT Number: NCT05578391
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Vigo, 36211, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.
In addition, the patients had to present some risk factor for severe disease:
Exclusion criteria
Admistration of one unit of convalescent plasma
Time frame: Day 14
Proportion of patients that need oxygen to achieve a saturation >93%
Time frame: Day 1
Safety of CP treatment was evaluated by the appearance of any adverse event related to the infusion
Time frame: Day 14 and 28
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.
Time frame: Until day 28
Worsening of symptoms was evaluated using the WHO progression scale
Fundacin Biomedica Galicia Sur
Other
PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease
Acronym: CoV-PlasGal
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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