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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Page 1 of 1 (2 locations)

1

Danderyd Hospital

Danderyd, Stockholm County, Sweden, 18257

2

Karolinska University Hospital

Stockholm, Sweden, 14186