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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
Danderyd Hospital
Danderyd, Sweden
Disease progression
Decrease in progression to requiring non-invasive or invasive ventilation
Time frame: 28 days
Adverse events (AE)
Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Time frame: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
Time ro resolution of fever and symptoms
Measured daily until discharged from the hospital.
Time frame: Until discharged from the hospital, up to 2 months
Clearance of viraemia
SARS-CoV-2 RNA detection by polymerase chain reaction (PCR) in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Time frame: 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)
Time to normalization of inflammatory parameter C-reactive protein (CRP). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter white blood cell count
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Time to normalization of inflammatory parameter white blood cell count (WBC). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter haemoglobin (Hb)
Time to normalization of inflammatory parameter haemoglobin (Hb). Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter Pro-calcitonin
Time to normalization of inflammatory parameter Pro-calcitonin. Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameter Creatine Kinase
Time to normalization of inflammatory parameter Creatine Kinase. Blood sample for this marker will be taken daily until normalized or discharged from hospital.
Time frame: Until discharged from the hospital, up to 2 months
Antibody response to SARS-CoV-2
Change in the antibody response to SARS-CoV-2 as measured in serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Time frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.