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Donated Antibodies Working Against nCoV (DAWN-Plasma)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Convalescent Plasma
Standard of care
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ZNA
  • Imelda Ziekenhuis Bonheiden
  • Institut Bordet
  • UMC Sint-Pieter
  • CHU Brugmann
  • Erasmus Ziekenhuis
  • UZ Brussel
  • Cliniques Universitaires St Luc
  • AZ Sint-Vincentius
  • AZ Maria Middelares
  • AZ Sint-Lucas
  • AZ Groeninge
  • UZ Leuven
  • CHC Liège Mont Légia
  • CHR Citadelle Liège
  • CHU Liège Sart-Tilman
  • CHU Ambroise Paré
  • CHR Jolimont Mons-Hainaut
  • AZ Delta
  • Sint-Trudo Ziekenhuis
  • Centre Hospitalier de Wallonie Picarde (CHwapi)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Convalescent Plasma

Standard of Care

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale)
0. Uninfected. Non viral RNA detected Ambulatory, Asymptomatic, viral RNA detected Ambulatory, Symptomatic, Independent Ambulatory, Symptomatic, Assistance needed Hospitalized, mild disease, No oxygen therapy needed Hospitalized, mild disease, Oxygen by mask of nasal prongs Hospitalized, severe disease, Oxygen by NIV or High flow Hospitalized, severe disease, Intubation and mechanical ventilation (pO2/FiO2>=150 OR SpO2/FIO2>=200) Hospitalized, severe disease, Mechanical ventilation (pO2/FiO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min) Hospitalized, severe disease, Mechanical ventilation pO2/FiO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO Death, Dead

Full Information

First Posted
June 9, 2020
Last Updated
October 18, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Federal Knowledge Centre (KCE)
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1. Study Identification

Unique Protocol Identification Number
NCT04429854
Brief Title
Donated Antibodies Working Against nCoV
Acronym
DAWN-Plasma
Official Title
A Randomized, Open-label, Adaptive, Proof-of-concept Clinical Trial of Donated Antibodies Working Against With COVID-19: DAWN-PLASMA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Federal Knowledge Centre (KCE)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
483 patients with 2:1 randomization. 320 patients receiving Convalescent Plasma - 163 patients receiving Standard of Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Convalescent Plasma
Intervention Description
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
Drug
Intervention Name(s)
Standard of care
Intervention Description
Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.
Primary Outcome Measure Information:
Title
Patients requiring mechanical ventilation or death
Description
Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.
Time Frame
No mechanical ventilation at day 15 after hospitalization.
Secondary Outcome Measure Information:
Title
Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale)
Description
0. Uninfected. Non viral RNA detected Ambulatory, Asymptomatic, viral RNA detected Ambulatory, Symptomatic, Independent Ambulatory, Symptomatic, Assistance needed Hospitalized, mild disease, No oxygen therapy needed Hospitalized, mild disease, Oxygen by mask of nasal prongs Hospitalized, severe disease, Oxygen by NIV or High flow Hospitalized, severe disease, Intubation and mechanical ventilation (pO2/FiO2>=150 OR SpO2/FIO2>=200) Hospitalized, severe disease, Mechanical ventilation (pO2/FiO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min) Hospitalized, severe disease, Mechanical ventilation pO2/FiO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO Death, Dead
Time Frame
day 15 and day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Meyfroidt, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Study Director
Facility Information:
Facility Name
ZNA
City
Antwerpen
ZIP/Postal Code
2050
Country
Belgium
Facility Name
Imelda Ziekenhuis Bonheiden
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Institut Bordet
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UMC Sint-Pieter
City
Brussel
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugmann
City
Brussel
ZIP/Postal Code
1030
Country
Belgium
Facility Name
Erasmus Ziekenhuis
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Sint-Vincentius
City
Deinze
ZIP/Postal Code
9800
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC Liège Mont Légia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHR Citadelle Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Liège Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
CHR Jolimont Mons-Hainaut
City
Mons
ZIP/Postal Code
7100
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Sint-Trudo Ziekenhuis
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Facility Name
Centre Hospitalier de Wallonie Picarde (CHwapi)
City
Tournai
ZIP/Postal Code
7500
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33246499
Citation
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. Erratum In: Trials. 2020 Dec 14;21(1):1024.
Results Reference
derived

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Donated Antibodies Working Against nCoV

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