Status:
COMPLETED
Convalescent Plasma Treatment in COVID-19
Lead Sponsor:
Aga Khan University
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred initially in December 2019 in the city of Wuhan, Hubei province, China. Patients mainly presented with respiratory...
Detailed Description
Objective: To investigate the efficacy and safety of transfusing convalescent plasma collected from patients who have recovered from COVID-19 disease to patients admitted at Aga Khan University Hospi...
Eligibility Criteria
Inclusion
- Inclusion Criteria For Patients:
- i. Inpatients at AKU with positive SARS-CoV-2 infection by rRT-PCR and who have provided written informed consent for inclusion in the trial;
- ii. Age ≥ 18 years;
- iii. Severe or immediately life-threatening COVID-19 defined by any of:
- Respiratory rate ≥ 30/min;
- Blood oxygen saturation ≤ 93% at room air;
- Partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio \< 300;
- Lung infiltrates \> 50% within 24 to 48 hours on radiology ( X-ray or CT scan);
- Need for mechanical ventilation.
- respiratory failure
- septic shock
- multiple organ dysfunction or failure
- Exclusion Criteria for patients:
- i. Negative rRT-PCR from respiratory secretions or blood within 48 h prior to assessment of eligibility.
- ii. History of allergic reaction to blood or plasma products (as judged by the investigator).
- iii. Medical conditions in which receipt of 500 mL intravascular volume may be detrimental to the patient (e.g., actively decompensated congestive heart failure).
- iv. Enrollment in any other clinical trial for an investigational therapy
Exclusion
Key Trial Info
Start Date :
April 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04476888
Start Date
April 26 2020
End Date
October 10 2020
Last Update
January 20 2021
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan