Donated Antibodies Working Against nCoV

NCT ID: NCT04429854

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2021-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Convalescent Plasma

Intervention Type: BIOLOGICAL

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.

Standard of care

Intervention Type: DRUG

Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.

Standard of Care

Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive. Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.

Group Type: OTHER

Standard of care

Intervention Type: DRUG

Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.

Interventions

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.

Intervention Type: BIOLOGICAL

Standard of care

Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures.

2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.

3. Male or non-pregnant female adult ≥18 years of age at time of enrolment.

4. Patient should be hospitalized

5. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:

1. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 60 hours prior to randomization or

2. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses

6. Illness of any duration, and at least one of the following:

1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or

2. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or

3. Requiring supplemental oxygen.

7. ABO D typing of the patient should be done at least once and the result should be known.

Exclusion Criteria

1. Receiving invasive (any mode where a patient has been intubated endotracheally, or via tracheostomy) or non-invasive (for instance, but not restricted to CPAP, PSV, PCV, SiMV) mechanical ventilation before or upon randomization.

2. Pregnancy or breast feeding.

3. Any medical condition which would impose an unacceptable safety hazard by participation to the study.

4. Patients with a documented grade 3 allergic reaction after the administration of fresh frozen plasma (i.e. systemic reaction with cardiovascular and/or respiratory involvement)

5. Patients that have treatment restriction that excludes mechanical ventilation and/or endotracheal intubation

6. Rituximab or another anti-CD20 monoclonal antibody (f.ex. obinutuzumab) has been administered during the year prior of the date of admission.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Knowledge Centre (KCE)

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geert Meyfroidt, MD, PhD

Role: STUDY_DIRECTOR

UZ Leuven

Locations

ZNA

Antwerp, , Belgium

Imelda Ziekenhuis Bonheiden

Bonheiden, , Belgium

Institut Bordet

Brussels, , Belgium

UMC Sint-Pieter

Brussels, , Belgium

CHU Brugmann

Brussels, , Belgium

Erasmus Ziekenhuis

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St Luc

Brussels, , Belgium

AZ Sint-Vincentius

Deinze, , Belgium

AZ Maria Middelares

Ghent, , Belgium

AZ Sint-Lucas

Ghent, , Belgium

AZ Groeninge

Kortrijk, , Belgium

UZ Leuven

Leuven, , Belgium

CHC Liège Mont Légia

Liège, , Belgium

CHR Citadelle Liège

Liège, , Belgium

CHU Liège Sart-Tilman

Liège, , Belgium

CHU Ambroise Paré

Mons, , Belgium

CHR Jolimont Mons-Hainaut

Mons, , Belgium

AZ Delta

Roeselare, , Belgium

Sint-Trudo Ziekenhuis

Sint-Truiden, , Belgium

Centre Hospitalier de Wallonie Picarde (CHwapi)

Tournai, , Belgium

Countries

Belgium

References

Devos T, Geukens T, Schauwvlieghe A, Arien KK, Barbezange C, Cleeren M, Compernolle V, Dauby N, Desmecht D, Grimaldi D, Lambrecht BN, Luyten A, Maes P, Moutschen M, Romano M, Seyler L, Nevessignsky MT, Vandenberghe K, van Griensven J, Verbeke G, Vlieghe E, Yombi JC, Liesenborghs L, Verhamme P, Meyfroidt G. A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial. Trials. 2020 Nov 27;21(1):981. doi: 10.1186/s13063-020-04876-0.

Reference Type: DERIVED

PMID: 33246499 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

S63992

Identifier Type: -

Identifier Source: org_study_id