There is one clinical trial.
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.
Description: 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.
Measure: Clinical status during follow-up at 30th day Time: 30th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: 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.
Measure: Clinical status during follow-up at 7th day Time: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: 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.
Measure: Clinical status during follow-up at 14th day Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: Hospital discharge or intrahospital death
Measure: Time until hospital discharge (days). Time: Whenever the patient is discharge from the hospital or die without discharge, through study completion, an average of 14 days from admissionDescription: ICU discharge or ICU death
Measure: Time until discharge from ICU (days) Time: Whenever the patient is discharge from ICU or die in ICU, through study completion, an average of 10 days from admissionDescription: Death and time to death
Measure: Time to death Time: In a 30 days follow up periodDescription: Time until complete functional recovery (according to basal status).
Measure: Time until complete functional recovery Time: Whenever the patient returns to basal functional status until 1 month from dischargeDescription: Percentage of participants with adverse events / serious adverse events
Measure: Percentage of participants with adverse events / serious adverse events Time: In a 30 days follow up periodDescription: Percentage of patients with negative SARS-CoV-3 PCR
Measure: Percentage of patients with negative SARS-CoV-3 PCR at Day 14th Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: D Dimer plasma concentration
Measure: D Dimer plasma concentration at Day 14th Time: 14th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: Ferritin plasma concentration
Measure: Ferritin plasma concentration at Day 13th Time: 13th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: Plasma concentration of neutralizing antibodies
Measure: Plasma concentration of neutralizing antibodies at Day 2nd Time: 2nd Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: Plasma concentration of neutralizing antibodies
Measure: Plasma concentration of neutralizing antibodies at Day 7th Time: 7th Day since study preparation infusion (Placebo or Convalescent SARS COVID-19 plasma)Description: Post-transfusion adverse reactions between study groups
Measure: Post-transfusion adverse reactions Time: In a 30 days follow up period