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.
Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2
convalescent patient plasma plus routine local standard of care
Other: Routine care for COVID-19 patients
local standard of care which include antivirals and supportive care
Inclusion Criteria:
- COVID-19 diagnosis
- Hypoxia, (Oxygen saturation of less than or equal 92% or PO2 < 60mmHg on arterial
blood gas analysis) and patient requiring oxygen therapy
- Evidence of infiltrates on Chest Xray or CT scan
- Able to give informed consent
- Patients between the ages of 21 and above with no upper age.
Exclusion Criteria:
- Patients with mild disease not requiring oxygen therapy
- Patients with normal CXR & CT scan
- Patients requiring ventilatory support
- Patients with a history of allergy to plasma, sodium citrate or methylene blue
- Patients with a history of autoimmune disease or selective IGA deficiency.
Royal College of Surgeons in Ireland - Bahrain
Manama, Bahrain
Manaf Al Qahtani, Dr., Principal Investigator
Royal College of Surgeons in Ireland - Bahrain