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Convalescent Plasma Trial in COVID -19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356534
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborators:
Salmaniya Medical Complex
Bahrain Defence Force Royal Medical Services, Military Hospital
Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali
Information provided by (Responsible Party):
Royal College of Surgeons in Ireland - Medical University of Bahrain

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
SARS-CoV 2 COVID-19 Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Other: Routine care for COVID-19 patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial
Actual Study Start Date : April 19, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in viral clearance [ Time Frame: through study completion up to 28 days ]
    Through the use of CT values

  2. Radiological change [ Time Frame: through study completion up to 28 days ]
    Chest Xray

  3. Change in white cell count [ Time Frame: through study completion up to 28 days ]
    As a measure of a change in inflammation

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Mortality rate [ Time Frame: Up to 28 days of the study ]
    Mortality rate due to COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356534


Contacts
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Contact: Manaf Al Qahtani, Dr. +97339766000 mqahtani@rcsi-mub.com
Contact: Pearl Wasif, MSc. +97333180191 PSulaiman@rcsi-mub.com

Locations
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Bahrain
Royal College of Surgeons in Ireland - Bahrain Recruiting
Manama, Bahrain
Contact: Manaf Al Qahtani, Dr.    +97339766000    mqahtani@rcsi-mub.com   
Contact: Pearl Wasif, MSc.    +97333180191    PSulaiman@rcsi-mub.com   
Principal Investigator: Manaf Al Qahtani, Dr.         
Sub-Investigator: Manal Al Sayed, Dr.         
Sub-Investigator: Abdulrahman Almadani, Dr.         
Sub-Investigator: Abdulkarim Abdulrahman, Dr.         
Sub-Investigator: Salman Yousif Alali, Dr.         
Sub-Investigator: Amal Hejab, Dr.         
Sub-Investigator: Stephen Atkin, Prof.         
Sub-Investigator: Sameer Otoom, Prof.         
Sub-Investigator: Pearl Wasif, MSc.         
Sub-Investigator: Alaa Al Zamrooni, Dr.         
Sponsors and Collaborators
Royal College of Surgeons in Ireland - Medical University of Bahrain
Salmaniya Medical Complex
Bahrain Defence Force Royal Medical Services, Military Hospital
Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali
Investigators
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Principal Investigator: Manaf Al Qahtani, Dr. Royal College of Surgeons in Ireland - Bahrain
Publications:

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Responsible Party: Royal College of Surgeons in Ireland - Medical University of Bahrain
ClinicalTrials.gov Identifier: NCT04356534    
Other Study ID Numbers: BDF/R&REC/2020-423
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal College of Surgeons in Ireland - Medical University of Bahrain:
Plasma Therapy
COVID-19
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs