Protocol summary
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Study aim
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Using COVID-19 convalescent plasma for the purpose of passive immunization in current COVID-19 pandemic
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Design
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Single arm, open label, clinical trial employing WHO recognized monitored emergency use of unregistered and experimental interventions (MEURI) study design. Sample size is 357
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Settings and conduct
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The places of the study: National Institute of Blood Disease & Bone Marrow Transplantation, Karachi; Liaquat University of Medical and Health Sciences, Jamshoro, Sindh; University of Health Science and children hospital, Lahore. Blinding in this study: Not Blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: informed consent must have been obtained, confirmed COVID-19 cases confirmed by RT-PCR laboratory tests, moderately severe or severe life-threatening COVID-19 related features:
Shortness of breath, respiratory rate ≥ 30/min, arterial blood oxygen saturation ≤ 92%, and/or lung infiltrates > 25% within 24 to 48 hours, Severe Life-threatening disease
Exclusion Criteria: Allergy history of plasma, sodium citrate and methylene blue; For patients with history of autoimmune system diseases or selective IgA deficiency, the application of convalescent plasma should be evaluated cautiously by clinicians. Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multiorgan failure.
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Intervention groups
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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.
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Main outcome variables
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Shortness of breath, Respiratory rate, Arterial blood oxygen saturation, Lung infiltrates, Respiratory failure, Shock, Multiple organ dysfunction
General information
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Reason for update
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Responsible person from sponsor updated
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200414047072N1
Registration date:
2020-04-28, 1399/02/09
Registration timing:
registered_while_recruiting
Last update:
2020-10-22, 1399/08/01
Update count:
1
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Registration date
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2020-04-28, 1399/02/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-14, 1399/01/26
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Expected recruitment end date
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2021-04-30, 1400/02/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Experimental Use of COVID-19 Convalescent Plasma for the Purpose Of Passive Immunization in Current COVID-19 Pandemic
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Public title
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Use of Convalescent Plasma in the treatment of COVID-19
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion Criteria for Donors; Volunteer enrollment (Informed consent will be obtained; Annexures-2A & 2B).
All the regulations related to ICH-GCP and Blood Transfusion Authority (BTA) Pakistan will be followed.
Should fulfill all the criteria of a healthy blood donor (with the exception of history of COVID-19 during last 4-8 weeks.
History of COVID-19 during last 4-8 weeks.
RT-PCR negative for SARS-CoV-2 RNA (carried out on nasopharyngeal or oropharyngeal specimen).
Age cutoff: 18-55 years.
Body weight cut off: >50 kg for men and > 45 kg for women.
At least a week been passed since last use of glucocorticoids.
A minimum of 2-week duration been passed since complete recovery.
Inclusion Criteria for Recipients: Volunteer enrollment (Informed consent will be obtained; Annexures-3A & 3B).
Confirmed COVID-19 cases confirmed by RT-PCR laboratory tests.
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) Critical COVID-19, defined by the presence of any of the following features: i.Respiratory failure, ii.Shock iii.Multiple organ dysfunction
Exclusion criteria:
Allergy history for plasma, sodium citrate and methylene blue
For patients with history of autoimmune system diseases or selective IgA deficiency, the application of convalescent plasma should be evaluated cautiously by clinicians.
Patients having evidence of uncontrolled cytokine release syndrome leading to end-stage multi organ failure.
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
357
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-04, 1399/01/16
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Ethics committee reference number
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4-87/NBC-COVID19-/20/03
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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Fever
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Timepoint
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registration day and week 4
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Method of measurement
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thermometer will be used for physical examination to check fever.
2
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Description
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Resolution of infection
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Timepoint
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28 days
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Method of measurement
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Two non-reactive Nucleic Acid Tests (NAT) for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs
3
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Description
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Lung infiltrates
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Timepoint
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registration day and week 4
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Method of measurement
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X-ray will be used
4
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Description
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Arterial blood oxygen saturation
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Timepoint
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registration day and week 4
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Method of measurement
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Lab test (blood from artery will used)
5
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Description
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Respiratory rate
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Timepoint
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registration day and week 4
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Method of measurement
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physical examination was conducted to measure the breath rate by counting chest or abdomen rises number over a minute.
Intervention groups
1
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Description
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Intervention group: Convalescent Plasma, Frozen Solution for infusion (FFP) for the prevention and treatment of Covid-19. Human plasma protein. The dosage depends upon the clinical situation and underlying disorder, use within 24 hours, administration based on ABO-blood group compatibility. Avoid shaking. It should be frozen within 8 hours after collection, stored at -18C or colder and have an expiration date one year from the date of collection. Not to exceed IV infusion rate of 1 mL/kg/min, emergency IND (eIND) approved by FDA. provided by Blood bank of the hospital mentioned in the IRB.
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Category
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Other
1
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Sponsor
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Grant name
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Research Grant
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hilton Pharma Pvt. Ltd.
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Proportion provided by this source
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40
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
2
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Sponsor
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Grant name
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Research Grant
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Institute Of Blood Disease and Bone Marrow Transplantation
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Proportion provided by this source
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60
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable