Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress. The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial.
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and has developed into a pandemic with serious global public health and economic sequelae. As of March 30, 2020, over 750,000 cases have been confirmed worldwide leading to over 34,000 deaths (https://coronavirus.jhu.edu/map.html). There is no current vaccine available, but there have been a number of reports of medication such as hydroxychloroquine having antiviral properties with efficacy against SARS-CoV-2. Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress. The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial Could using convalescent plasma transfusion, from recovered COVID19 patients with antibody against COVID-19 be beneficial in treatment of COVID19 patients with hypoxia and pneumonia, in order to avoid or delay the need for invasive ventilation? This is a prospective, interventional and randomized open label trial involving 40 patients with COVID-19 who are in respiratory distress, with the criteria that all require oxygen therapy and have radiological evidence of pneumonia, 20 of whom will receive a single transfusion of convalescent patient plasma plus routine care, compared to 20 COVID-19 patients who will receive routine care alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
convalescent patient plasma plus routine local standard of care
local standard of care which include antivirals and supportive care
Royal College of Surgeons in Ireland - Bahrain
Manama, Bahrain
Requirement for invasive ventilation
Could the plasma therapy avoid or delay the need for invasive ventilation
Time frame: through study completion up to 28 days
Change in viral clearance
Through the use of CT values
Time frame: through study completion up to 28 days
Radiological change
Chest Xray
Time frame: through study completion up to 28 days
Change in white cell count
As a measure of a change in inflammation
Time frame: through study completion up to 28 days
C reactive protein measurement
A change in C reactive protein as a measure of a change in inflammation
Time frame: through study completion up to 28 days
lactate dehydrogenase measurement
A change in lactate dehydrogenase as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
Procalcitonin measurement
A change in procalcitonin as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
D Dimer measurement
A change in D Dimer as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
Ferritin measurement
A change in Ferritin as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
Troponin T measurement
A change in troponin T as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
Brain naturetic peptide measurement
A change in brain naturetic peptide as a measure of an improvement in the severity of the disease process
Time frame: through study completion up to 28 days
Mortality rate
Mortality rate due to COVID-19
Time frame: Up to 28 days of the study
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