Status:
COMPLETED
Donated Antibodies Working Against nCoV
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Federal Knowledge Centre (KCE)
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
483 Patients enrolled
Trial Details
Trial ID
NCT04429854
Start Date
May 2 2020
End Date
April 30 2021
Last Update
October 26 2021
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
ZNA
Antwerp, Belgium, 2050
2
Imelda Ziekenhuis Bonheiden
Bonheiden, Belgium, 2820
3
Institut Bordet
Brussels, Belgium, 1000
4
UMC Sint-Pieter
Brussels, Belgium, 1000