Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia (CCAP)

August 2, 2022 updated by: Thomas Benfield

Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
      • Arhus, Denmark
        • Aarhus University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
      • Copenhagen, Denmark
        • Bispebjerg Hospital
      • Herlev, Denmark
        • Herlev Gentofte Hospital
      • Herning, Denmark
        • Herning Hospital
      • Hillerød, Denmark
        • Nordsjællands Hospital
      • Hvidovre, Denmark
        • Hvidovre Hospital
      • Kolding, Denmark
        • Kolding Hospital
      • Odense, Denmark
        • Odense University Hospital
      • Roskilde, Denmark
        • Roskilde Hospital
      • Vejle, Denmark
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality or need of invasive mechanical ventilation
Time Frame: 28 days
Composite outcome
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events
Time Frame: 90 days
Number of participants with adverse events with possible relation to study drug
90 days
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
90 days
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
90 days
Ventilator-free days
Time Frame: 28 days
Number of days without mechanical ventilation
28 days
Organ failure-free days
Time Frame: 28 days
Number of days without organ-failure
28 days
Duration of ICU stay
Time Frame: 90 days
Number of days in ICU
90 days
Mortality rate
Time Frame: 7, 14, 21, 28 and 90 days
Number of deaths by any cause
7, 14, 21, 28 and 90 days
Length of hospital stay
Time Frame: 90 days
Days from the date of hospital admission for COVID-19 to the date of discharge
90 days
Duration of supplemental oxygen
Time Frame: 90 days
Days requiring supplement oxygen
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Benfield

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

March 16, 2021

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25032020
  • 2020-001367-88 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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