An interventional study of plasma therapy using convalescent plasma with antibody against SARS-CoV-2 and Routine care for COVID-19 patients in SARS-CoV 2 and COVID-19, sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain. Completed at 1 site in Bahrain. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain · Not applicable, Interventional, and Treatment
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 40 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Royal College of Surgeons in Ireland - Medical University of Bahrain is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
local standard of care which include antivirals and supportive care
Other: Routine care for COVID-19 patients
convalescent patient plasma 400ml given as 200ml over 2 hours in 2 consecutive days, plus routine local standard of care
Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2
convalescent patient plasma plus routine local standard of care
local standard of care which include antivirals and supportive care
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
Plan to share: Yes — Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Dr Manaf will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.
Access criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.
Ran from Apr 2020 to primary completion in Jun 2020, 1 month.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 1 month is below that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal College of Surgeons in Ireland - Medical University of Bahrain