Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Joakim Dillner
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Disease progression
Study Overview
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 varying degrees of COVID-19 illness.
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Convalescent plasma treatment
All participants will receive a bag of convalescent plasma. The bag volume will be 180-200 ml. The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions. The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines.
Intervention: SARS-CoV-2 convalescent plasma (Biological)
Outcomes
Primary Outcomes
Disease progression
Time Frame: 28 days
Decrease in progression to requiring non-invasive or invasive ventilation
Secondary Outcomes
- Inflammatory parameter Pro-calcitonin(Until discharged from the hospital, up to 2 months)
- Time ro resolution of fever and symptoms(Until discharged from the hospital, up to 2 months)
- Clearance of viraemia(Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.)
- Antibody response to SARS-CoV-2(Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.)
- Inflammatory parameter C-reactive protein (CRP)(Until discharged from the hospital, up to 2 months)
- Inflammatory parameter white blood cell count(Until discharged from the hospital, up to 2 months)
- Adverse events (AE)(The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.)
- Inflammatory parameter haemoglobin (Hb)(Until discharged from the hospital, up to 2 months)
- Inflammatory parameter Creatine Kinase(Until discharged from the hospital, up to 2 months)
Investigators
Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Karolinska University Hospital