Convalescent Plasma Trial in COVID -19 Patients

October 25, 2021 updated by: Royal College of Surgeons in Ireland - Medical University of Bahrain

Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain
        • Royal College of Surgeons in Ireland - Bahrain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement for invasive ventilation
Time Frame: through study completion up to 28 days
Could the plasma therapy avoid or delay the need for invasive ventilation
through study completion up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in viral clearance
Time Frame: through study completion up to 28 days
Through the use of CT values
through study completion up to 28 days
Radiological change
Time Frame: through study completion up to 28 days
Chest Xray
through study completion up to 28 days
Change in white cell count
Time Frame: through study completion up to 28 days
As a measure of a change in inflammation
through study completion up to 28 days
C reactive protein measurement
Time Frame: through study completion up to 28 days
A change in C reactive protein as a measure of a change in inflammation
through study completion up to 28 days
lactate dehydrogenase measurement
Time Frame: 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
through study completion up to 28 days
Procalcitonin measurement
Time Frame: through study completion up to 28 days
A change in procalcitonin as a measure of an improvement in the severity of the disease process
through study completion up to 28 days
D Dimer measurement
Time Frame: 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
through study completion up to 28 days
Ferritin measurement
Time Frame: through study completion up to 28 days
A change in Ferritin as a measure of an improvement in the severity of the disease process
through study completion up to 28 days
Troponin T measurement
Time Frame: 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
through study completion up to 28 days
Brain naturetic peptide measurement
Time Frame: 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
through study completion up to 28 days
Mortality rate
Time Frame: Up to 28 days of the study
Mortality rate due to COVID-19
Up to 28 days of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons in Ireland - Medical University of Bahrain

Collaborators

Bahrain Defence Force Hospital
Salmaniya Medical Complex
Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali

Investigators

  • Principal Investigator: Manaf Al Qahtani, Dr., Royal College of Surgeons in Ireland - Bahrain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2020

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

July 9, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDF/R&REC/2020-423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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