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

Primary Purpose

COVID, Corona Virus Infection, Viral Pneumonia

Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Convalescent anti-SARS-CoV-2 plasma
Infusion placebo
Sponsored by
Thomas Benfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Bispebjerg Hospital
  • Rigshospitalet
  • Herlev Gentofte Hospital
  • Herning Hospital
  • Nordsjællands Hospital
  • Hvidovre Hospital
  • Kolding Hospital
  • Odense University Hospital
  • Roskilde Hospital
  • Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Convalescent plasma

Infusion placebo

Arm Description

Will receive active treatment with convalescent anti-SARS-CoV-2 plasma (600 ml) as a single dose iv infusion in addition to standard care.

Will receive placebo treatment with saline 0.9% (2 x 300 ml) as an iv single dose infusion in addition to standard care.

Outcomes

Primary Outcome Measures

All-cause mortality or need of invasive mechanical ventilation
Composite outcome

Secondary Outcome Measures

Frequency of adverse events
Number of participants with adverse events with possible relation to study drug
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 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
Ventilator-free days
Number of days without mechanical ventilation
Organ failure-free days
Number of days without organ-failure
Duration of ICU stay
Number of days in ICU
Mortality rate
Number of deaths by any cause
Length of hospital stay
Days from the date of hospital admission for COVID-19 to the date of discharge
Duration of supplemental oxygen
Days requiring supplement oxygen

Full Information

First Posted
April 10, 2020
Last Updated
August 2, 2022
Sponsor
Thomas Benfield
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1. Study Identification

Unique Protocol Identification Number
NCT04345289
Brief Title
Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
Acronym
CCAP
Official Title
Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
DSMB advise due to high probability of futility
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Benfield

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Corona Virus Infection, Viral Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent plasma
Arm Type
Active Comparator
Arm Description
Will receive active treatment with convalescent anti-SARS-CoV-2 plasma (600 ml) as a single dose iv infusion in addition to standard care.
Arm Title
Infusion placebo
Arm Type
Placebo Comparator
Arm Description
Will receive placebo treatment with saline 0.9% (2 x 300 ml) as an iv single dose infusion in addition to standard care.
Intervention Type
Biological
Intervention Name(s)
Convalescent anti-SARS-CoV-2 plasma
Other Intervention Name(s)
Convalescent plasma
Intervention Description
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Intervention Type
Other
Intervention Name(s)
Infusion placebo
Intervention Description
Saline 0.9% (600 ml) as an iv single dose infusion
Primary Outcome Measure Information:
Title
All-cause mortality or need of invasive mechanical ventilation
Description
Composite outcome
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
Number of participants with adverse events with possible relation to study drug
Time Frame
90 days
Title
Frequency of severe adverse events
Description
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Time Frame
90 days
Title
Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
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 activities
Time Frame
90 days
Title
Ventilator-free days
Description
Number of days without mechanical ventilation
Time Frame
28 days
Title
Organ failure-free days
Description
Number of days without organ-failure
Time Frame
28 days
Title
Duration of ICU stay
Description
Number of days in ICU
Time Frame
90 days
Title
Mortality rate
Description
Number of deaths by any cause
Time Frame
7, 14, 21, 28 and 90 days
Title
Length of hospital stay
Description
Days from the date of hospital admission for COVID-19 to the date of discharge
Time Frame
90 days
Title
Duration of supplemental oxygen
Description
Days requiring supplement oxygen
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Hansen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Simone Bastrup Israelsen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Louise Thorlacius-Ussing, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karen Brorup Heje Pedersen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Clara Clausen, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michaela Tinggaard, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nichlas Hovmand, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Aarhus University Hospital
City
Arhus
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Herlev Gentofte Hospital
City
Herlev
Country
Denmark
Facility Name
Herning Hospital
City
Herning
Country
Denmark
Facility Name
Nordsjællands Hospital
City
Hillerød
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
Kolding Hospital
City
Kolding
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia

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