Convalescent Plasma Treatment in COVID-19 (COLLATE)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Convalescent plasma, Covid 19
Eligibility Criteria
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
Sites / Locations
- Aga Khan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Treatment arm/CP recipient
Control arm
Patients with severe/critical COVID 19 who will receive 500 ml of Convalescent plasma (CP), obtained from donors who have been recovered from SARS-CoV-2 infection. These patients may or may not get other treatment modalities e.g. steroids,Tocilizumab, Azithromycin etc
Patients with severe/critical COVID 19 who will not receive Convalescent plasma (CP). These will be those who were recruited during the period before CP becomes available or for whom no compatible CP is available. These patients will receive one or more of the other treatment modalities e.g. steroids,Tocilizumab, Azithromycin etc