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 varying degrees of COVID-19 illness.
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 limited to small studies and case series on severely ill patients. The
proposed study assesses the safety and efficacy earlier in the course of illness, in slightly
less severe patients with the possibility of detecting less severe adverse events and the
potential for early treatment to hinder the development of severe disease. Plasma is
collected from consenting donors who have recovered from SARS-CoV-2.
Biological: SARS-CoV-2 convalescent plasma
Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
Inclusion Criteria:
- 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 Criteria:
- 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.
Danderyd Hospital
Danderyd, Sweden
Johan Ursing, MD, PhD, Principal Investigator
Danderyd Hospital