Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04352751
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04352751
Study Brief:
Protocol Section:
NCT04352751