Status:
UNKNOWN
Convalescent Plasma in the Treatment of Covid-19
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Finnish Red Cross Blood Service
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigates the possible adverse effects and effectiveness of convalescent plasma for patients infected with SARS-CoV-2. Following provision of informed consent, patients will be randomize...
Detailed Description
SARS-CoV-2 pandemic presents a serious global public health threat urgently requiring both prophylactic and therapeutic interventions. The entry of SARS-CoV-2 into human cells involves a binding betwe...
Eligibility Criteria
Inclusion
- Acute Covid-19 disease at the time of recruitment laboratory-confirmed by upper respiratory tract PCR
- Patient recently (0-4 days earlier) admitted to hospital due to Covid-19 infection
- Symptom onset 10 days before recruitment (if symptom onset unknown the duration is calculated from positive PCR-test)
- the day should be recorded from the duration of the Covid-19 symptoms/positive test result
- The dose of LMWH thromboprofylaxis should be recorded
- Written informed consent.
Exclusion
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded ( inhaled or topical steroids allowed)
- Regular (daily), systemic administration of corticosteroids at the time on inclusion (inhaled or topical corticosteroids are allowed)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Pregnancy or lactation.
- Alcohol or drug abuse.
- Suspected non-compliance.
- Presence of VTE, including pulmonary embolism or other manifestations of thrombosis
- Use of any investigational drug (other than hydroxychloroquine) or vaccine within 30 days prior to first dose of study vaccine or planned use during study period.
- Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction as judged by investigator.
- Known immunoglobulin A (IgA) deficiency
- Existing treatment limitations: do-not-resuscitate (DNR) order or withholding treatment in ICU
- Any other criteria which, as judged by investigator, might compromise a patient's well-being or ability to participate in the study or its outcome.
- Active malignant disease
- CP not available for patients blood type
- Patient cannot assign written consent
- No personnel available for CP of placebo transfusion
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2023
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04730401
Start Date
January 27 2021
End Date
January 30 2023
Last Update
July 7 2022
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00270