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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
333
Convalescent SARS COVID-19 plasma from a pool of 10 donor plasma. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
Single infusion of saline solution, in addition to standard care. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Clinical status during follow-up at 30th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Time frame: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Clinical status during follow-up at 7th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Time frame: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Clinical status during follow-up at 14th day
Ordinal outcome with six mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) death; (2) in intensive care; (3) hospitalised but requiring supplemental oxygen; (4) hospitalised and not requiring supplemental oxygen; (5) discharged but unable to resume normal activities; or (6) discharged with full resumption of normal activities.
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Time until hospital discharge (days).
Hospital discharge or intrahospital death
Time frame: Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admission
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Time until discharge from ICU (days)
ICU discharge or ICU death
Time frame: Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admission
Time to death
Death and time to death
Time frame: In a 30 days follow up period
Time until complete functional recovery
Time until complete functional recovery (according to basal status).
Time frame: Whenever the patient returns to basal functional status until 1 month from discharge
Percentage of participants with adverse events / serious adverse events
Percentage of participants with adverse events / serious adverse events
Time frame: In a 30 days follow up period
Percentage of patients with negative SARS-CoV-3 PCR at Day 14th
Percentage of patients with negative SARS-CoV-3 PCR
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
D Dimer plasma concentration at Day 14th
D Dimer plasma concentration
Time frame: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Ferritin plasma concentration at Day 13th
Ferritin plasma concentration
Time frame: 13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 2nd
Plasma concentration of neutralizing antibodies
Time frame: 2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Plasma concentration of neutralizing antibodies at Day 7th
Plasma concentration of neutralizing antibodies
Time frame: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)
Post-transfusion adverse reactions
Post-transfusion adverse reactions between study groups
Time frame: In a 30 days follow up period