NCT04345289

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Thomas Benfield · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID
• Corona Virus Infection
• Viral Pneumonia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2020-04-14
• Last updated: 2022-08-04

Locations

12 sites across 1 country: Denmark