Status:
COMPLETED
Efficacy of Convalescent Plasma Therapy in Patients With COVID-19
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Currently, no effective treatments are available for the COVID-19. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to comb...
Detailed Description
Study Centres: Institute of Liver and Biliary Sciences Sector D-1, Vasant Kunj New Delhi -110070 \- Collection and testing of Convalescent Plasma Treatment Centres Lok Nayak Jai Prakash Hospital (...
Eligibility Criteria
Inclusion
- Recipient
- \- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
- Patients on ventilator (in last 24 hours)
- Respiratory distress, RR ≥30 beats/min
- Oxygen saturation level less than 90 % in resting state
- Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg
- Lung infiltrates \> 50% within 24 to 48 hours
- Recipient
Exclusion
- Patient/ family members who do not give consent to participate in the study.
- Patients with age less than 18 years
- Patients presenting with multi-organ failure
- Pregnancy
- Individuals with HIV and Viral Hepatitis and Cancer
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Hemodynamic instability requiring vasopressors
- Previous history of allergy to plasma
- Cirrhosis
- Severe renal impairment with GFR\< 30ml/min or recipients of RRT, peritoneal dialysis
- Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable Angina
- Donor Inclusion Criteria for Plasmapheresis
- Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days.
- Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart.
- Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs \& Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.
- Donors
Key Trial Info
Start Date :
June 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04425915
Start Date
June 14 2020
End Date
December 15 2020
Last Update
October 14 2021
Active Locations (3)
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1
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, India, 110006
2
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070
3
Rajiv Gandhi Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, India, 110093