Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
- Conditions
- COVIDCorona Virus InfectionViral Pneumonia
- Interventions
- Biological: Convalescent anti-SARS-CoV-2 plasmaOther: Infusion placebo
- Registration Number
- NCT04345289
- Lead Sponsor
- Thomas Benfield
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 147
- ≥18 years of age
- Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
- Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2 <300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia
- For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)*
- Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Convalescent plasma Convalescent anti-SARS-CoV-2 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. Infusion placebo 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.
- Primary Outcome Measures
Name Time Method All-cause mortality or need of invasive mechanical ventilation 28 days Composite outcome
- Secondary Outcome Measures
Name Time Method Duration of supplemental oxygen 90 days Days requiring supplement oxygen
Frequency of severe adverse events 90 days Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Frequency of adverse events 90 days Number of participants with adverse events with possible relation to study drug
Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status 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 28 days Number of days without mechanical ventilation
Organ failure-free days 28 days Number of days without organ-failure
Duration of ICU stay 90 days Number of days in ICU
Mortality rate 7, 14, 21, 28 and 90 days Number of deaths by any cause
Length of hospital stay 90 days Days from the date of hospital admission for COVID-19 to the date of discharge
Trial Locations
- Locations (12)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Arhus, Denmark
Nordsjællands Hospital
🇩🇰Hillerød, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Roskilde Hospital
🇩🇰Roskilde, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Herlev Gentofte Hospital
🇩🇰Herlev, Denmark
Herning Hospital
🇩🇰Herning, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Kolding Hospital
🇩🇰Kolding, Denmark
Vejle Hospital
🇩🇰Vejle, Denmark