NCT04429854

Donated Antibodies Working Against nCoV

A Randomized, Open-label, Adaptive, Proof-of-concept Clinical Trial of Donated Antibodies Working Against With COVID-19: DAWN-PLASMA

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This a phase II, proof-of-concept study. In the present study, we investigate if the administration of blood-plasma from patients recovered from COVID-19, could be effective to treat patients who are severely ill because of a COVID-19 infection. The general idea behind the transfusion, is that plasma of recovered patients contains antibodies that could eliminate the novel coronavirus causing COVID-19, and lead to a less severe course of the disease, or a faster healing. Simply put, in this study we would like to investigate whether 'borrowed immunity' from a person who has cured from this disease, could be applied to cure other patients more rapidly.

Detailed description

In December 2019, a new coronavirus (the SARS-CoV-2 virus) emerged, which spread fast across the world, and has led to a pandemic. The disease caused by this virus, called COVID-19, has a mild course in a high number of infected people, but is known to have a more severe course in some. Currently, there are no successful treatments with a known effect on the course of the disease in patients suffering from COVID-19. In this study, we will examine whether plasma, a treatment that has been used in human subjects for other diseases (and is known to be safe), can be used to influence the course of COVID-19 towards a lower severity. The aim of the study is to evaluate clinical efficacy and safety of convalescent plasma for COVID-19. This clinical trial is an adaptive, randomized, open-label phase II proof-of-concept study to investigate the safety and effect of potentially interesting treatments, for the treatment of hospitalized adult patients suffering from COVID-19. Because an active treatment for COVID-19 is lacking, plasma donation is now being proposed. To investigate this effect of plasma, we will compare two groups of patients. One group will get standard treatment, plus plasma from a patient recently cured from COVID-19. A second group will get standard treatment alone. In this study, 2 patients out of 3 will receive plasma, and 1 patient out of 3 will receive standard treatment alone. After the study, we will be able to establish whether plasma donation is useful or not.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Convalescent Plasma	4 units of convalescent plasma: * 2 units of plasma are administered within 12h after randomization, but preferably as soon as practically possible * 2 units of plasma should be administered between 24h and 36h after the first infusion Other investigational products may be added as part of the adaptive study design.
DRUG	Standard of care	Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.

Timeline

• Start date: 2020-05-02
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-06-12
• Last updated: 2021-10-26

Locations

21 sites across 1 country: Belgium