Convalescent Plasma Trial in COVID -19 Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control group local standard of care which include antivirals and supportive care |
Other: Routine care for COVID-19 patients
local standard of care which include antivirals and supportive care
|
| Experimental: Intervention group 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
|
Outcome Measures
Primary Outcome Measures
- Requirement for invasive ventilation [through study completion up to 28 days]
Could the plasma therapy avoid or delay the need for invasive ventilation
Secondary Outcome Measures
- Change in viral clearance [through study completion up to 28 days]
Through the use of CT values
- Radiological change [through study completion up to 28 days]
Chest Xray
- Change in white cell count [through study completion up to 28 days]
As a measure of a change in inflammation
- C reactive protein measurement [through study completion up to 28 days]
A change in C reactive protein as a measure of a change in inflammation
- lactate dehydrogenase measurement [through study completion up to 28 days]
A change in lactate dehydrogenase as a measure of an improvement in the severity of the disease process
- Procalcitonin measurement [through study completion up to 28 days]
A change in procalcitonin as a measure of an improvement in the severity of the disease process
- D Dimer measurement [through study completion up to 28 days]
A change in D Dimer as a measure of an improvement in the severity of the disease process
- Ferritin measurement [through study completion up to 28 days]
A change in Ferritin as a measure of an improvement in the severity of the disease process
- Troponin T measurement [through study completion up to 28 days]
A change in troponin T as a measure of an improvement in the severity of the disease process
- Brain naturetic peptide measurement [through study completion up to 28 days]
A change in brain naturetic peptide as a measure of an improvement in the severity of the disease process
- Mortality rate [Up to 28 days of the study]
Mortality rate due to COVID-19
Eligibility Criteria
Criteria
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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal College of Surgeons in Ireland - Bahrain | Manama | Bahrain |
Sponsors and Collaborators
- Royal College of Surgeons in Ireland - Medical University of Bahrain
- Salmaniya Medical Complex
- Bahrain Defence Force Hospital
- Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali
Investigators
- Principal Investigator: Manaf Al Qahtani, Dr., Royal College of Surgeons in Ireland - Bahrain
Study Documents (Full-Text)
None provided.More Information
Publications
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- BDF/R&REC/2020-423