Status:
COMPLETED
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)
Lead Sponsor:
Joakim Dillner
Collaborating Sponsors:
Danderyd Hospital
Karolinska Institutet
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
There is currently no effective treatment for COVID-19 except best supportive care. The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varyin...
Detailed Description
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-19. However, data is limi...
Eligibility Criteria
Inclusion
- Age 18 and \<81 years
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of \>20 breaths per minute without supplemental oxygen treatment
- A 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 and the Rh system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Disease duration \>8 Days
- Estimated glomerular filtration rate \<60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg), breast feeding,
- History of severe allergic reactions
- Inability to give informed consent
- Significantly compromised immunity.\*
- Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04390178
Start Date
April 10 2020
End Date
December 31 2020
Last Update
December 16 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Danderyd Hospital
Danderyd, Sweden, 182 57