Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: convalescent plasma: Arm A Subjects will be administered about 500 ml of apheresis derived Convalescent plasma intravenously in a single dose along with standard care of therapy
Control
Sponsors
International Stemcell Services Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years and older (male or female) - Laboratory confirmation of COVID â?? 19 - CT image is characteristic of 2019 novel corona virus pneumonia (optional) - Sign a consent form and follow the test plan and follow-up process. Inclusion criteria for donors of plasma - 18 years and older (male or female) - Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge. - COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample. - The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis). - Sign a consent form and follow the test plan and follow-up process.
Exclusion criteria
Exclusion criteria: - Patients with autoimmune disease in the past or screening - Those who have serious disease that affect their overall survival as decided by the treating clinican - Self reports HIV or syphilis infected persons - Pregnant or lactating women - Continuous use of immunosuppressive agents or organ transplants in the past 6 months. Exclusion criteria for donors - Patients who become sick again after getting discharged - RNA positive for COVID or TTI positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, efficacy. Side effects measured by Chest Radiograph. Improvement of clinical symptoms including duration of fever, respiratory distress, pneumonia, cough, sneezing, and diarrhea within 3 days of the convalescent plasma transfusion. Oxygen Saturation, Pao2/Fio2. Decrease in viral load as detected by PCR, serum antibody titer. Routine blood biochemical parameters including renal and liver function tests. Sequential Organ Failure Assessment (SOFA)Timepoint: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of mortality - Marker of immunological function, ferritin, CRP, d-dimer - Ventilatory and extracorporeal membrane oxygenation (ECMO) supports before and after treatmentTimepoint: All parameters will be assessed on Day 0, Day 1, Day 3, Day 14. d-dimer assessed on Day 0, Day 1, Day 3, Day 14 and Day 28. | — |
Countries
India
Contacts
Public ContactMeena Dalal
International Stemcell Services Ltd
Outcome results
None listed