Status:
TERMINATED
Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Prothya Biosolutions
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Passive immunization with immunoglobulins is occasionally used as therapy for the treatment of viral infectious diseases. Immunoglobulins are used for the treatment of CMV disease, and is effective as...
Detailed Description
Secondary (exploratory) objectives * Evaluate the effect of 300ml convP on hospital stay * Evaluate the change of the 8-point WHO COVID19 disease severity scale on day 15 and 30 * Evaluate the change...
Eligibility Criteria
Inclusion
- Patients with PCR confirmed COVID disease
- Admitted to the hospital
- The most recent PCR positive sample is \<96hrs old
- Written informed consent by patient or legal patient representative
- Age at least 18 years
Exclusion
- Participation in another intervention trial on the treatment of COVID-19 that falls under the Dutch law human research (WMO) and in which individual patients are randomized to different treatment options
- Known IgA deficiency
- Invasive ventilation for already \>96 hours
- Donors: Eligibility for plasma donation
- Inclusions Criteria:
- A history of COVID infection that was documented by PCR
- Known ABO-Resus(D) blood group
- A screening for irregular antibodies with a titer ≤ 1:32
- Asymptomatic for at least 14 days
- Written informed consent regarding the plasmapheresis procedure
- Tested negative for HIV, HBV, HCV, HEV, HTLV and syfilis
Key Trial Info
Start Date :
April 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04342182
Start Date
April 8 2020
End Date
September 30 2020
Last Update
April 1 2022
Active Locations (18)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA
2
NoordWest Ziekenhuisgroep
Alkmaar, Netherlands
3
Onze Lieve Vrouwen Gasthuis
Amsterdam, Netherlands
4
Rijnstate Ziekenhuis
Arnhem, Netherlands