Status:
UNKNOWN
Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020
Lead Sponsor:
Hilton Pharma
Conditions:
Covid-19
Eligibility:
All Genders
18-55 years
Phase:
NA
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...
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 ge...
Eligibility Criteria
Inclusion
- FOR DONORS:
- Volunteer enrolment (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: 18-55years
- Body weight cut off: \>50 kg for men and \> 45kg for women
- FOR RECIPIENTS:
- Volunteer enrolment (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. CriticalCOVID-19, defined by the presence of any of the following features: i. Respiratory failure, ii. Shock iii. Multiple organ dysfunction
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04352751
Start Date
May 1 2020
End Date
April 1 2021
Last Update
September 29 2020
Active Locations (1)
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1
National Institute of Blood Diseases and Bone Marrow Transplantation (NIBD)
Karachi, Sindh, Pakistan, 75300