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

NCT04345289 | Terminated Phase 3 DMC

• 2 other identifiers: 250320202020-001367-88
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 12

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.

Conditions

COVID; Corona Virus Infection; Viral Pneumonia

Outcome Measures

Primary Outcomes (1)

• All-cause mortality or need of invasive mechanical ventilation

  Composite outcome

  28 days

Secondary Outcomes (9)

• Frequency of adverse events

  90 days

• Frequency of severe adverse events

  90 days

• Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status

  90 days

• Ventilator-free days

  28 days

• Organ failure-free days

  28 days

Study Arms (2)

Convalescent plasma

ACTIVE COMPARATOR

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

Infusion placebo

PLACEBO COMPARATOR

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

Interventions

Convalescent anti-SARS-CoV-2 plasma BIOLOGICAL

Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)

Also known as: Convalescent plasma

Convalescent plasma

Infusion placebo OTHER

Saline 0.9% (600 ml) as an iv single dose infusion

Infusion placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Benfield: lead

Study Sites (12)

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herlev Gentofte Hospital

Herlev, Denmark

Location

Herning Hospital

Herning, Denmark

Location

Nordsjællands Hospital

Hillerød, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Kolding Hospital

Kolding, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

Related Publications (41)

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MeSH Terms

Conditions

Coronavirus Infections; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: May 1, 2020
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (12)