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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
Sponsor:
Information provided by (Responsible Party):
Thomas Benfield, Hvidovre University Hospital

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.


Condition or disease Intervention/treatment Phase
COVID Corona Virus Infection Viral Pneumonia Biological: Convalescent anti-SARS-CoV-2 plasma Other: Infusion placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
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)
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.

Primary Purpose: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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 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




Primary Outcome Measures :
  1. All-cause mortality or need of invasive mechanical ventilation [ Time Frame: 28 days ]
    Composite outcome


Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 90 days ]
    Number of participants with adverse events with possible relation to study drug

  2. 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

  3. 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

  4. Ventilator-free days [ Time Frame: 28 days ]
    Number of days without mechanical ventilation

  5. Organ failure-free days [ Time Frame: 28 days ]
    Number of days without organ-failure

  6. Duration of ICU stay [ Time Frame: 90 days ]
    Number of days in ICU

  7. Mortality rate [ Time Frame: 7, 14, 21, 28 and 90 days ]
    Number of deaths by any cause

  8. Length of hospital stay [ Time Frame: 90 days ]
    Days from the date of hospital admission for COVID-19 to the date of discharge

  9. Duration of supplemental oxygen [ Time Frame: 90 days ]
    Days requiring supplement oxygen



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Thomas Benfield, MD, DMSc +45 38622302 thomas.lars.benfield@regionh.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Henrik Nielsen, MD, DMSc         
Contact       henrik.nielsen@rn.dk   
Aarhus University Hospital Not yet recruiting
Arhus, Denmark
Contact: Lars Østergaard, MD, DMSc         
Contact       larsoest@rm.dk   
Bispebjerg Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Stine Johnsen, MD, PhD       stine.johnsen.01@regionh.dk   
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Jan Gerstoft, MD, DMSc         
Contact       jan.gerstoft@regionh.dk   
Herlev Gentofte Hospital Not yet recruiting
Herlev, Denmark
Contact: Kasper Iversen, MD, DMSc       kasper.karmark.iversen@regionh.dk   
Herning Hospital Not yet recruiting
Herning, Denmark
Contact: Rajesh Mohey, MD, PhD       rajemohe@rm.dk   
Nordsjællands Hospital Not yet recruiting
Hillerød, Denmark
Contact: Birgitte Lindegaard Madsen, MD, PhD       birgitte.lindegaard.madsen@regionh.dk   
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Contact: Thomas Benfield, MD, DMSc    +4538622302    thomas.lars.benfield@regionh.dk   
Kolding Hospital Not yet recruiting
Kolding, Denmark
Contact: Janne Jensen, MD, PhD       janne.jensen@rsyd.dk   
Odense University Hospital Not yet recruiting
Odense, Denmark
Contact: Isik Johansen, MD, DMSc       isik.somuncu.johansen@rsyd.dk   
Roskilde Hospital Not yet recruiting
Roskilde, Denmark
Contact: Lothar Wiese, MD, PhD       low@regionsjaelland.dk   
Vejle Hospital Not yet recruiting
Vejle, Denmark
Contact: Ole Hilberg, MD, DMSc       ole.hilberg@rsyd.dk   
Sponsors and Collaborators
Thomas Benfield
Investigators
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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:
World Health Organization. Coronavirus disease 2019 (COVID-19) - Situation Report 67. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200327-sitrep-67-covid-19.pdf?sfvrsn=b65f68eb_4.

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Responsible Party: Thomas Benfield, Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04345289    
Other Study ID Numbers: 25032020
2020-001367-88 ( EudraCT Number )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections