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.
The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment. The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently. As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Saline 0.9% (600 ml) as an iv single dose infusion
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
All-cause mortality or need of invasive mechanical ventilation
Composite outcome
Time frame: 28 days
Frequency of adverse events
Number of participants with adverse events with possible relation to study drug
Time frame: 90 days
Frequency of severe adverse events
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Time frame: 90 days
Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
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 activities
Time frame: 90 days
Ventilator-free days
Number of days without mechanical ventilation
Time frame: 28 days
Organ failure-free days
Number of days without organ-failure
Time frame: 28 days
Duration of ICU stay
Number of days in ICU
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Herlev Gentofte Hospital
Herlev, Denmark
Herning Hospital
Herning, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Kolding Hospital
Kolding, Denmark
Odense University Hospital
Odense, Denmark
...and 2 more locations
Time frame: 90 days
Mortality rate
Number of deaths by any cause
Time frame: 7, 14, 21, 28 and 90 days
Length of hospital stay
Days from the date of hospital admission for COVID-19 to the date of discharge
Time frame: 90 days
Duration of supplemental oxygen
Days requiring supplement oxygen
Time frame: 90 days