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

NCT04345289 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2022-08-04

No results posted yet for this study

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

Interventions

BIOLOGICAL

Convalescent anti-SARS-CoV-2 plasma

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

OTHER

Infusion placebo

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

Sponsors & Collaborators

  • Thomas Benfield

    lead OTHER

Principal Investigators

  • Sandra Hansen, MD · Hvidovre University Hospital

  • Simone Bastrup Israelsen, MD · Hvidovre University Hospital

  • Louise Thorlacius-Ussing, MD · Hvidovre University Hospital

  • Karen Brorup Heje Pedersen, MD · Hvidovre University Hospital

  • Clara Clausen, MD · Hvidovre University Hospital

  • Michaela Tinggaard, MD · Hvidovre University Hospital

  • Nichlas Hovmand, MD · Hvidovre University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2021-03-16
Completion
2021-03-16

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345289 on ClinicalTrials.gov