Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study)
NCT ID: NCT04342182
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
86 participants
INTERVENTIONAL
2020-04-08
2020-09-30
Brief Summary
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Neutralizing antibodies against MERS, SARS-CoV-1 and SARS-CoV-2 have been shown to be present in patients previously infected with MERS, SARS-CoV-1 and SARS-CoV-2 respectively. During the 2003 SARS outbreak in Hong-Kong,a non-randomized study in hospitalized SARS patients showed that treatment with convalescent plasma (convP) from SARS-recovered donors significantly increased the day 22 discharge rate and decreased mortality. A study in non-human primates showed that rhesus macaques could not be re-infected with SARS-CoV-2 after primary infection.
With no proven effective therapy against COVID, this study will evaluate the safety and efficacy of convalescent plasma from COVID-recovered donors as a treatment for hospitalized patients with symptomatic COVID-19. The study will focus on patients who tested positive for SARS-CoV-2 in the last 96 hours before inclusion
Primary objectives
• Decrease overall mortality in patients within COVID disease
Study design:
This trial is a randomized comparative trial. Patients will be randomized between the infusion of 300mL of convP with standard of care.
Patient population:
Patients with PCR confirmed COVID disease, age \>18 years Donors will be included with a known history of COVID who have been asymptomatic for at least 14 days.
Intervention: 300mL of convP Duration of treatment: ConvP will be given as a one-time infusion Duration of follow up: For the primary endpoint: until discharge or death before day 60, whichever comes first. For the secondary endpoints (with separate consent) up to 1 year.
Target number of patients: 426 Target number of donors: 100 Expected duration of accrural: 36 months
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Detailed Description
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* 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 of the 8-point WHO COVID19 disease severity scale on day 15 in the subgroup of patients with a baseline neutralizing antibody titer (PRNT50) \<80
* Evaluate the effect of 300ml convP on mortality in patients admitted to the ICU
* Evaluate the effect of 300ml plasma therapy on hospital days for patients admitted to the ICU within 24 hours after admission
* Evaluate the impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
* Evaluate the difference in effect of convP on mortality in patients with a duration of symptoms \< or \> the median duration of symptoms in the study population
* Evaluate the impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
* Safety of convP therapy
* Evaluate the impact of covP on long-term lung function
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Convalescent plasma
Standard of care plus 300mL of convalescent plasma from COVID-19 recovered donors
Convalescent plasma
Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.
Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products
Standard of care
standard of care (supportive care, oxygen, antibiotics)
No interventions assigned to this group
Interventions
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Convalescent plasma
Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.
Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
* Age \<18 years and \> 65 years
* Weight \<50kg
* Medical history of heart failure
* History of transfusion with red blood cells, platelets or plasma
* History of organ- or tissue transplant
* A cumulative stay in the United Kingdom of ≥ 6 months in the period between 01-01-1980 and 31-12-1996
* A history of i.v. drug use
* Insulin dependent diabetes
* An underlying severe chronic illness (i.e. history of heart failure, cancer or stroke)
* Tested positive for HLA- or HNA-antibodies
18 Years
ALL
No
Sponsors
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Prothya Biosolutions
INDUSTRY
Erasmus Medical Center
OTHER
Responsible Party
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Bart Rijnders
MD, PhD
Principal Investigators
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Bart Rijnders, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus Medical Center
Rotterdam, South Holland, Netherlands
NoordWest Ziekenhuisgroep
Alkmaar, , Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Martini Hospital
Groningen, , Netherlands
Spaarna Gasthuis
Haarlem, , Netherlands
Alrijne Ziekenhuis
Leiderdorp, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
ZorgSaam Hospital
Terneuzen, , Netherlands
Haaglanden Medisch Centrum
The Hague, , Netherlands
Bernhoven Hospital
Uden, , Netherlands
VieCuri
Venlo, , Netherlands
Countries
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References
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Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.
Other Identifiers
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NL73489.078.20
Identifier Type: -
Identifier Source: org_study_id
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