Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1500
Summary
- Conditions
- Corona Virus Infection
- COVID
- Viral Pneumonia
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04345289
- Collaborators
- Not Provided
- Investigators
- 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
Get Well Soon