A Phase 2/3 interventional study of Convalescent plasma in COVID-19, sponsored by Erasmus Medical Center. Terminated at 18 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Erasmus Medical Center · Phase 2/3, Interventional, and Treatment
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 prophylaxis when given soon after exposure to varicella zoster virus, rabies, and hepatitis B virus.
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
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
Secondary (exploratory) objectives
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 86 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Donors: Eligibility for plasma donation
Inclusions Criteria:
Exclusion Criteria:
Standard of care plus 300mL of convalescent plasma from COVID-19 recovered donors
Biological: Convalescent plasma
standard of care (supportive care, oxygen, antibiotics)
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
Overall mortality until discharge from the hospital or a maximum of 60 days after admission whichever comes first
the mortality in the 300ml convP group will be compared with the control arm
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP therapy on hospital days
the hospital days in the 300ml convP group will be compared with the control arm
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on weaning from oxygen therapy
A patient will be considered weaned from oxygen therapy when the patient did not receive oxygen for at least 24 hours.
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP on overall mortality in patients admitted to the ICU within 24 hours after admission
the overall mortality in hospital days in patients admitted tot the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Difference in the effect of convP on mortality in patients with a duration of symptoms less or more the median duration of symptoms in the study population
The mortality in patients with a duration of symptoms less than the median duration of symptoms in the study population will be compared with the mortality in patients with a duration of symptoms more than the median duration of symptoms in the study population
Time frame: hospital discharge or a maximum of 60 days whichever comes first
Impact of 300ml convP therapy on ICU days in patients admitted to the ICU within 24 hours after admission
the ICU days in hospital days in patients admitted to the ICU within 24 hours after admission in the 300ml convP group will be compared with the patients admitted tot the ICU within 24 hours after admission in the control arm
Time frame: Until hospital discharge, estimated average 4 weeks
Impact of plasma therapy on the decrease in SARS-CoV2 shedding from airways
airway samples will be taken on day 1 - 3 - 5 - 7 - 10 - 14 - and at discharge
Time frame: until hospital discharge, estimated average 2 weeks
Impact of CTL and NK cell immunity on the likelihood of being protected from immune serum transfer
Blood wil be drawn at day 1, day 7 and day 14
Time frame: until hospital discharge, extimated average 2 weeks
Safety of convP therapy
Evaluation of Severe Adverse Events and transfusion related adverse events
Time frame: until hospital discharge or a maximum of 60 days whichever comes first
Change of the 8-point WHO COVID19 disease severity scale on day 15
The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1
Time frame: until day 15
Change of the 8-point WHO COVID19 disease severity scale on day 30
The WHO COVID19 disease severity scale on day 30 will be compared with the WHO COVID19 disease severity scale on day 1 and day 15
Time frame: until day 30
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.
The WHO COVID19 disease severity scale on day 15 will be compared with the WHO COVID19 disease severity scale on day 1 in patients with a baseline neutralizing antibody titer (PRNT50) \<80.
Time frame: until day 15
Impact of plasma therapy on risk of long-term structural lung damage and lung function
Low dose CT and lung function is done 6 weeks after discharge and if abnormal again 3 months after discharge.
Time frame: up to 12 months after plasma transfusion
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center