Clinical trial NCT04356534: Convalescent Plasma Trial in COVID -19 Patients
Official title: Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV 2
COVID-19
Keywords: Plasma Therapy
COVID-19
Lead sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain
Sponsor class: OTHER
Collaborators: name: Salmaniya Medical Complex
name: Bahrain Defence Force Hospital
name: Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali
First posted: 2020-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 transfusion of convalescent patient plasma plus routine care, compared to 20 COVID-19 patients who will receive routine care alone.
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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.

Primary outcomes:
measure: Requirement for invasive ventilation
timeFrame: through study completion up to 28 days
Secondary outcomes:
measure: Change in viral clearance
timeFrame: through study completion up to 28 days
measure: Radiological change
timeFrame: through study completion up to 28 days
measure: Change in white cell count
timeFrame: through study completion up to 28 days
measure: C reactive protein measurement
timeFrame: through study completion up to 28 days
measure: lactate dehydrogenase measurement
timeFrame: through study completion up to 28 days
measure: Procalcitonin measurement
timeFrame: through study completion up to 28 days
measure: D Dimer measurement
timeFrame: through study completion up to 28 days
measure: Ferritin measurement
timeFrame: through study completion up to 28 days
measure: Troponin T measurement
timeFrame: through study completion up to 28 days
measure: Brain naturetic peptide measurement
timeFrame: through study completion up to 28 days
measure: Mortality rate
timeFrame: Up to 28 days of the study
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Royal College of Surgeons in Ireland - Bahrain
Study officials:
affiliation: Royal College of Surgeons in Ireland - Bahrain
name: Manaf Al Qahtani, Dr.
role: PRINCIPAL_INVESTIGATOR
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