Using COVID-19 convalescent plasma for the purpose of passive immunization in current COVID-19 pandemic
Design
Single arm, open label, clinical trial employing WHO recognized monitored emergency use of unregistered and experimental interventions (MEURI) study design. Sample size is 357
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Shortness of breath, Respiratory rate, Arterial blood oxygen saturation, Lung infiltrates, Respiratory failure, Shock, Multiple organ dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047072N1
Registration date:2020-04-28, 1399/02/09
Registration timing:registered_while_recruiting
Last update:2020-04-28, 1399/02/09
Update count:1
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Saba Fatima
Name of organization / entity
Hilton Pharma Pvt. Ltd.
Country
Pakistan
Phone
+92 21 35072224
Email address
sabafatima@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-14, 1399/01/26
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Experimental Use of COVID-19 Convalescent Plasma for the Purpose Of Passive Immunization in Current COVID-19 Pandemic
Public title
Use of Convalescent Plasma in the treatment of COVID-19
Purpose
Other
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
357
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Bioethics Committee (NBC) Pakistan
Street address
Pakistan Health Research Council, Shahrah-e-Jamhuriat, Off Constitution Avenue, Sector G-5/2, Islamabad
City
Karachi
Postal code
44050
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
4-87/NBC-COVID19-/20/03
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Fever
Timepoint
registration day and week 4
Method of measurement
thermometer will be used for physical examination to check fever.
2
Description
Resolution of infection
Timepoint
28 days
Method of measurement
Two non-reactive Nucleic Acid Tests (NAT) for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs
3
Description
Lung infiltrates
Timepoint
registration day and week 4
Method of measurement
X-ray will be used
4
Description
Arterial blood oxygen saturation
Timepoint
registration day and week 4
Method of measurement
Lab test (blood from artery will used)
5
Description
Respiratory rate
Timepoint
registration day and week 4
Method of measurement
physical examination was conducted to measure the breath rate by counting chest or abdomen rises number over a minute.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
National Institute of Blood Disease & Bone Marrow Transplantation
Full name of responsible person
Professor Tahir S Shamsi
Street address
ST 2/A Block 17 Gulshan-e-Iqbal KDA Scheme 24 Karachi, Pakistan.