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Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020

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ClinicalTrials.gov Identifier: NCT04352751
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hilton Pharma

Brief Summary:

Experimental Use of Convalescent Plasma of Passive Immunisation In Current COVID-19 Pandemic in Pakistan in 2020 Rationale & Objective: This study would help to gather real-life setting clinical data in local population, ultimately leading to increased evidence based management of the disease condition in the said population.

Eligibility:

  1. informed consent must have been obtained
  2. confirmed COVID-19 cases confirmed by RT-PCR laboratory tests
  3. moderately severe or severe life-threatening COVID-19 related features: a) Moderately Severe disease as defined by the following features: i) Shortness of breath, ii) respiratory rate ≥ 30/min, iii) arterial blood oxygen saturation ≤ 92%, iv) and/or lung infiltrates > 25% within 24 to 48 hours 67 b) Severe Life-threatening disease as defined by: i) respiratory failure, ii) shock, and/or § multiple organ dysfunction

    Exclusion Criteria:

    Allergy history of plasma, sodium citrate and methylene blue; 2. For patients with history of autoimmune system diseases or selective IgA deficiency, 3. the application of convalescent plasma should be evaluated cautiously by clinicians.

  4. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multiorgan failure.

Methodology:

Total sample size is n=2000. A case report form (CRF) will have to be generated for each corona virus patient at baseline and the completion of study endpoint (at the time of discharge and at 4 weeks after experimental treatment modality using convalescent plasma.

  • A unique identification number will be issued for each patient in this protocol.
  • This data will be recorded in the national database. Data sources & Analysis: Patient data originating from patient medical record and assessments (mentioned in table below) will be recorded in the study CRF. Safety data (AEs and SAEs) from any time point during the study will be recorded in the study CRF. All analyses will be performed by third party statistician on SPSS. For continuous variables, summary statistics included n (number of observations), mean, standard deviation, median, minimum and maximum values, as well as frequencies and percentages for categorical variables will be presented.

Condition or disease Intervention/treatment Phase
Covid-19 Other: convalescent plasma Not Applicable

Detailed Description:

Passive immunization involves the administration of antibodies against a given agent to a susceptible individual for the purpose of preventing or treating an infectious disease due to that agent. A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease. When used for therapy, antibody is most effective when administered shortly after the onset of symptoms. The reason for temporal variation in efficacy is not well understood but could reflect that passive antibody works by neutralizing the initial inoculums, which is likely to be much smaller than that of established disease. As an example, passive antibody therapy for pneumococcal pneumonia was most effective when administered shortly after the onset of symptoms, and there was no benefit if antibody administration was delayed past the third day of disease.

The therapeutic benefits of convalescent plasma were formally studied in animal models in early 20th century. It efficacy was first determined in 1916, when 26 poliomyelitis patients were treated with convalescent plasma from polio survivors. Subsequently, therapeutic and prophylactic significance was explored in influenza and measles. Transfusion of immune plasma is a standard treatment modality for various viral hemorrhagic fevers. Its efficacy in treating Ebola Virus Disease is also well established. Studies have reported reduction viral load in patients with H1N1 influenza. Of special attention is the meta-analysis, carried out by Mair-Jenkinset al, concluding effectiveness of passive immunization as a treatment option for severe viral acute respiratory infections caused by SARS corona virus, influenza A (H1N1), avian influenza A (H5N1) and Spanish influenza A. Efficacy of convalescent plasma has been anecdotally reported in SARS-CoV-2 infections.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open label, clinical trial employing WHO recognized monitored emergency use of unregistered and experimental interventions (MEURI) study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Single Arm

Intervention: Convalescent plasma (Frozen Solution for infusion) obtained from COVID-19 recovered patients.

The dosage depends upon the clinical situation and underlying disorder. Children: 15 ml/kg over 4-6 hours once in patients under 35 kg body weight. Adults: maximum 450 - 500 ml over 4-6 hours once in all adults patients.

Other: convalescent plasma
  • Plasmapheresis, 900 - 1000 mL each time.
  • Standard apheresis plasma collection protocol using Haemonetics MCS+ intermittent blood flow system or Terumo Optia, Cobe-Spectra, Trima or Fresenius continuous flow system to be used.
  • Isovolumic saline replacement should be done.
  • Each donor can donate convalescent plasma again after an interval of every 2 weeks




Primary Outcome Measures :
  1. Change in COVID-19 severity status [ Time Frame: Up to 09 days ]

    Improvement in disease severity will be regarded as a shift from Critical to Severe or from Severe to Mild disease category. The various disease categories are defined as following (17):

    1. Mild COVID-19, defined by the absence of features given in criteria for moderate and severe disease.
    2. Severe COVID-19, defined by the presence of any of the following features:

    i. Shortness of breath ii. Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iiii. Lung infiltrates > 50% within 24 to 48 hours c. Critical COVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

FOR DONORS:

  1. Volunteer enrolment (Informed consent will be obtained; Annexures-2A & 2B).
  2. All the regulations related to ICH-GCP and Blood Transfusion Authority (BTA) Pakistan will be followed.
  3. Should fulfill all the criteria of a healthy blood donor (with the exception of history of COVID-19 during last 4-8 weeks.
  4. History of COVID-19 during last 4-8 weeks
  5. RT-PCR negative for SARS-CoV-2 RNA (carried out on nasopharyngeal or oropharyngeal specimen)
  6. Age cutoff: 18-55years
  7. Body weight cut off: >50 kg for men and > 45kg for women

FOR RECIPIENTS:

  1. Volunteer enrolment (Informed consent will be obtained; Annexures-3A & 3B).
  2. Confirmed COVID-19 cases confirmed by RT-PCR laboratory tests
  3. Severe or Critical COVID-19 related features (8):

    a. Severe COVID-19, defined by the presence of any of the following features: i. Shortness of breath ii. Respiratory rate ≥ 30/min, iii. Arterial blood oxygen saturation ≤ 93%, iv. Lung infiltrates > 50% within 24 to 48 hours b. CriticalCOVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction

Exclusion Criteria:

  1. Allergy history for plasma, sodium citrate and methylene blue
  2. For patients with history of autoimmune system diseases or selective IgA deficiency, the application of convalescent plasma should be evaluated cautiously by clinicians.
  3. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multi organ failure.

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): NCT04352751


Contacts
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Contact: Dr. Arshi Naz, PhD,Diplab 00923232234376 labarshi@yahoo.com
Contact: Dr. Neeta Maheshwary, MBBS Mphil 00923208247773 drneeta@hiltonpharma.com

Locations
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Pakistan
National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD) Recruiting
Karachi, Sindh, Pakistan, 75300
Contact: Dr. Arshi Naz    00923232234376    labarshi@yahoo.com   
Sub-Investigator: Professor Javed Akram         
Sub-Investigator: Professor Bikha Ram Deverajani         
Sub-Investigator: Dr Arshi Naz         
Sub-Investigator: Professor Shahtaj Masood Khan         
Sub-Investigator: Professor Faridoun         
Sub-Investigator: Professor Ikram Din Ujjan         
Sub-Investigator: Dr Lubna Meraj         
Sponsors and Collaborators
Hilton Pharma
Investigators
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Principal Investigator: Dr. Tahir Shamsi, FRCP MRCPath National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hilton Pharma
ClinicalTrials.gov Identifier: NCT04352751    
Other Study ID Numbers: PIPK- 0000 /NIBD-0000/2020
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases