Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia (CCAP)
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|ClinicalTrials.gov Identifier: NCT04345289|
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : July 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID Corona Virus Infection Viral Pneumonia||Biological: Convalescent anti-SARS-CoV-2 plasma Other: Infusion placebo||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Adaptive multi-arm trial comparing convalescent plasma against control group. Interim analyses are included at 300 and 700 included participants to compare the effect and safety of the experimental treatment to control (placebo). The results of the interim analyses are used to decide if the treatments should be discontinued due to either futility or harm. The study is discontinued if either of the predefined stopping criteria are met.
Additional experimental treatments may be added as they become available. Any efficacious treatment identified in this or any other high-quality RCT may become the new SOC after consensus by national and international societies, and, thus, the control arm will change accordingly and in parallel.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Both convalescent plasma and placebo will be administered via a colored intravenous line with a colored sleeve disguising the fluid bag.
In order to achieve blinding of participants and treating personnel, patients randomized to active treatment will also receive placebo treatment.
|Official Title:||Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial|
|Actual Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||June 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
Active Comparator: Convalescent plasma
Will receive active treatment with convalescent anti-SARS-CoV-2 plasma (600 ml) as a single dose iv infusion in addition to standard care.
Biological: Convalescent anti-SARS-CoV-2 plasma
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Other Name: Convalescent plasma
Placebo Comparator: Infusion placebo
Will receive placebo treatment with saline 0.9% (2 x 300 ml) as an iv single dose infusion in addition to standard care.
Other: Infusion placebo
Saline 0.9% (600 ml) as an iv single dose infusion
- All-cause mortality or need of invasive mechanical ventilation [ Time Frame: 28 days ]Composite outcome
- Frequency of adverse events [ Time Frame: 90 days ]Number of participants with adverse events with possible relation to study drug
- Frequency of severe adverse events [ Time Frame: 90 days ]Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
- Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status [ Time Frame: 90 days ]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
- Ventilator-free days [ Time Frame: 28 days ]Number of days without mechanical ventilation
- Organ failure-free days [ Time Frame: 28 days ]Number of days without organ-failure
- Duration of ICU stay [ Time Frame: 90 days ]Number of days in ICU
- Mortality rate [ Time Frame: 7, 14, 21, 28 and 90 days ]Number of deaths by any cause
- Length of hospital stay [ Time Frame: 90 days ]Days from the date of hospital admission for COVID-19 to the date of discharge
- Duration of supplemental oxygen [ Time Frame: 90 days ]Days requiring supplement oxygen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345289
|Contact: Thomas Benfield, MD, DMSc||+45 email@example.com|
|Aalborg University Hospital||Not yet recruiting|
|Contact: Henrik Nielsen, MD, DMSc|
|Aarhus University Hospital||Not yet recruiting|
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|Bispebjerg Hospital||Not yet recruiting|
|Contact: Stine Johnsen, MD, PhD firstname.lastname@example.org|
|Rigshospitalet||Not yet recruiting|
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|Contact: Birgitte Lindegaard Madsen, MD, PhD email@example.com|
|Contact: Thomas Benfield, MD, DMSc +4538622302 firstname.lastname@example.org|
|Kolding Hospital||Not yet recruiting|
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|Odense University Hospital||Not yet recruiting|
|Contact: Isik Johansen, MD, DMSc firstname.lastname@example.org|
|Roskilde Hospital||Not yet recruiting|
|Contact: Lothar Wiese, MD, PhD email@example.com|
|Vejle Hospital||Not yet recruiting|
|Contact: Ole Hilberg, MD, DMSc firstname.lastname@example.org|
|Study Director:||Sandra Hansen, MD||Hvidovre University Hospital|
|Study Director:||Simone Bastrup Israelsen, MD||Hvidovre University Hospital|
|Study Director:||Louise Thorlacius-Ussing, MD||Hvidovre University Hospital|
|Study Director:||Karen Brorup Heje Pedersen, MD||Hvidovre University Hospital|
|Study Director:||Clara Clausen, MD||Hvidovre University Hospital|
|Study Director:||Michaela Tinggaard, MD||Hvidovre University Hospital|
|Study Director:||Nichlas Hovmand, MD||Hvidovre University Hospital|