- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429854
Donated Antibodies Working Against nCoV (DAWN-Plasma)
A Randomized, Open-label, Adaptive, Proof-of-concept Clinical Trial of Donated Antibodies Working Against With COVID-19: DAWN-PLASMA
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Antwerpen, Belgium, 2050
- ZNA
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Bonheiden, Belgium, 2820
- Imelda Ziekenhuis Bonheiden
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Brussel, Belgium, 1090
- UZ Brussel
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Brussel, Belgium, 1000
- Institut Bordet
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Brussel, Belgium, 1000
- UMC Sint-Pieter
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Brussel, Belgium, 1030
- CHU Brugmann
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Brussel, Belgium, 1070
- Erasmus ziekenhuis
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Brussel, Belgium, 1200
- Cliniques Universitaires St Luc
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Deinze, Belgium, 9800
- AZ Sint-Vincentius
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Gent, Belgium, 9000
- AZ Maria Middelares
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Gent, Belgium, 9000
- AZ Sint-Lucas
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Kortrijk, Belgium, 8500
- AZ Groeninge
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Leuven, Belgium, 3000
- UZ Leuven
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Liège, Belgium, 4000
- CHC Liège Mont Légia
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Liège, Belgium, 4000
- CHR Citadelle Liège
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Liège, Belgium, 4000
- CHU Liège Sart-Tilman
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Mons, Belgium, 7000
- CHU Ambroise Pare
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Mons, Belgium, 7100
- CHR Jolimont Mons-Hainaut
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Roeselare, Belgium, 8800
- AZ Delta
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Sint-Truiden, Belgium, 3800
- Sint-Trudo ziekenhuis
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Tournai, Belgium, 7500
- Centre Hôspitalier de Wallonie Picarde (CHWAPI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Convalescent Plasma
4 units of convalescent plasma:
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4 units of convalescent plasma:
Other investigational products may be added as part of the adaptive study design.
Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.
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OTHER: 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.
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Since there are no current approved treatment options for COVID-19, the standard of care is mostly supportive.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients requiring mechanical ventilation or death
Time Frame: No mechanical ventilation at day 15 after hospitalization.
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Primary outcome of the study is the number of patients alive without mechanical ventilation at day 15 after hospitalization.
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No mechanical ventilation at day 15 after hospitalization.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical status of subject at day 15 and day 30 (on a 10-point "WHO progression" ordinal scale)
Time Frame: day 15 and day 30
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0. Uninfected. Non viral RNA detected
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day 15 and day 30
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Geert Meyfroidt, MD, PhD, UZ Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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