COVID-19 Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Clinical Trial of Convalescent Plasma for the Treatment of COVID-19 Pneumonia With Severity Criteria
A multicenter randomized, double-blind, placebo-controlled clinical trial of Convalescent SARS COVID-19 plasma versus Placebo to evaluate the effect between arms on an ordinal score of six mutually exclusive categories of clinical status at day 30 after study initiation.
Introduction
The use of convalescent plasma in the treatment of infectious diseases has been empirically
performed for more than a century. It is based upon the assumption that providing exogenous
neutralizing antibodies may provide protection while affected patients mount their own immune
response. This therapeutic approach appears of particular interest in the context of the
current pandemic, in which there is no specific vaccine available nor adequately proven
effective pharmacological treatments.
Study purpose, hypothesis and general design
Purpose of the study: evaluate the effectiveness and safety of convalescent plasma in the
treatment of SARS-CoV-2 pneumonia (Covid-19) Hypothesis: Convalescent plasma significantly
improves the clinical outcome in patients with Covid-19 pneumonia and severity criteria.
Multicenter randomized, double-blind, placebo.controlled clinical trial. Placebo will be a
saline solution.
3. Methodological sustain for including a control arm with placebo Quality evidence about the
effectiveness of convalescent plasma in the treatment of Covid-19 pneumonia is not yet
available. Although case series and anecdotal reports appear encouraging, the implementation
of its use in routine clinical practice requires the validation through controlled clinical
trials. In addition the collection, administration and control of plasma is technically
demanding and needs a clear support before broadly recommending it. Different scientific
institutions and international organisms had clearly suggested to prioritize the application
of novel therapeutic techniques with yet unproven efficacy within the context of clinical
studies over its empirical use.
On the other hand, for the present study, intervention strategy is proposed in "add-on"
modality over the antiviral treatment that each participant may be already receiving, since
they represent completely different therapeutic approaches. As such, participation in the
present study will not condition the possibility of the participants to receive other
treatments, either in intervention or control arms.
4. Study objectives Primary objective Analyze the difference between arms on an ordinal score
of six mutually exclusive categories at day 30 after study initiation. This score includes
the following categories
;
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