Donated Antibodies Working Against nCoV

NCT04429854 | Completed Phase 2 DMC

• 1 other identifier: S63992
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 21

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Patients requiring mechanical ventilation or death

  Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.

  No mechanical ventilation at day 15 after hospitalization.

Secondary Outcomes (1)

• Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale)

  day 15 and day 30

Study Arms (2)

Convalescent Plasma

EXPERIMENTAL

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

Biological: Convalescent Plasma; Drug: Standard of care

Standard of Care

OTHER

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.

Drug: Standard of care

Interventions

Convalescent Plasma 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.

Convalescent Plasma

Standard of care DRUG

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

Convalescent Plasma; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures.
• Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
• Male or non-pregnant female adult ≥18 years of age at time of enrolment.
• Patient should be hospitalized
• Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:
• 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
• 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
• Illness of any duration, and at least one of the following:
• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
• Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or
• Requiring supplemental oxygen.
• ABO D typing of the patient should be done at least once and the result should be known.

You may not qualify if:

• 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.
• Pregnancy or breast feeding.
• Any medical condition which would impose an unacceptable safety hazard by participation to the study.
• 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)
• Patients that have treatment restriction that excludes mechanical ventilation and/or endotracheal intubation
• Rituximab or another anti-CD20 monoclonal antibody (f.ex. obinutuzumab) has been administered during the year prior of the date of admission.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Federal Knowledge Centre (KCE): collaborator

Study Sites (21)

ZNA

Antwerp, 2050, Belgium

Location

Imelda Ziekenhuis Bonheiden

Bonheiden, 2820, Belgium

Location

Institut Bordet

Brussels, 1000, Belgium

Location

UMC Sint-Pieter

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1030, Belgium

Location

Erasmus Ziekenhuis

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

AZ Sint-Vincentius

Deinze, 9800, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

AZ Sint-Lucas

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHC Liège Mont Légia

Liège, 4000, Belgium

Location

CHR Citadelle Liège

Liège, 4000, Belgium

Location

CHU Liège Sart-Tilman

Liège, 4000, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

CHR Jolimont Mons-Hainaut

Mons, 7100, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Sint-Trudo Ziekenhuis

Sint-Truiden, 3800, Belgium

Location

Centre Hospitalier de Wallonie Picarde (CHwapi)

Tournai, 7500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33246499 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Geert Meyfroidt, MD, PhD

  UZ Leuven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 483 patients with 2:1 randomization. 320 patients receiving Convalescent Plasma - 163 patients receiving Standard of Care

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: May 2, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (21)