|drug1203||Infusion placebo Wiki||1.00|
|D011024||Pneumonia, Viral NIH||0.13|
|D045169||Severe Acute Respiratory Syndrome NIH||0.05|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
Description: Composite outcomeMeasure: All-cause mortality or need of invasive mechanical ventilation Time: 28 days
Description: Number of participants with adverse events with possible relation to study drugMeasure: Frequency of adverse events Time: 90 days
Description: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelinesMeasure: Frequency of severe adverse events Time: 90 days
Description: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activitiesMeasure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status Time: 90 days
Description: Number of days without mechanical ventilationMeasure: Ventilator-free days Time: 28 days
Description: Number of days without organ-failureMeasure: Organ failure-free days Time: 28 days
Description: Number of days in ICUMeasure: Duration of ICU stay Time: 90 days
Description: Number of deaths by any causeMeasure: Mortality rate Time: 7, 14, 21, 28 and 90 days
Description: Days from the date of hospital admission for COVID-19 to the date of dischargeMeasure: Length of hospital stay Time: 90 days
Description: Days requiring supplement oxygenMeasure: Duration of supplemental oxygen Time: 90 days