Status:
COMPLETED
Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
Lead Sponsor:
Joakim Dillner
Collaborating Sponsors:
Danderyd Hospital
Karolinska University Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited...
Eligibility Criteria
Inclusion
- Age 18 or older
- Admitted to a study hospital
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- Written informed consent after meeting with a study physician and ability and willingness to complete follow up
Exclusion
- No matching plasma donor (Exact matching in both the ABO system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Estimated glomerular filtration rate \<60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg)
- Breast feeding
- History of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy)
- Inability to give informed consent
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04384497
Start Date
May 7 2020
End Date
December 1 2020
Last Update
December 3 2021
Active Locations (2)
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1
Danderyd Hospital
Danderyd, Stockholm County, Sweden, 18257
2
Karolinska University Hospital
Stockholm, Sweden, 14186