Effect of convalescent plasma in COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025803
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Recipient Inclusion Criteria:
- 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 greater than or equal to 30 beats/min
Oxygen saturation level less than 90 % in resting state
Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg
Lung infiltrates > 50% within 24 to 48 hours
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.
Recipient Exclusion Criteria:
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
Donors Exclusion Criteria:
Do not 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 and have not been tested for HLA antibodies or are HLA antibody positive if tested and previously transfused donors (to prevent TRALI)
Donors who have taken steroids during treatment for COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier) <br/ ><br>Timepoint: Day 28
- Secondary Outcome Measures
Name Time Method Correlation of titers in COVID-19 convalescent plasma donors and correlate with duration of illness, the severity of symptoms, duration of hospital stay, drugs used in therapy, duration between recovery, and donationTimepoint: Day 28;Cytokines and acute phase reactantsTimepoint: Day 28;Duration of hospital stayTimepoint: Day 28;Duration of Intensive Care Unit stayTimepoint: Day 28;Duration of oxygen therapyTimepoint: Day 28;Incidence of adverse effects in both groupsTimepoint: Day 28;Mortality in both groups at day 7 and day 28Timepoint: Day 7 and day 28;Presence of antibodies against SARS-CoV-2 in serum after plasma administrationTimepoint: days 0, 3, 7, 14, 21 & 28;Proportion of patients in each category according to the ordinal scaleTimepoint: 48 hours,day 7, day 14, and day 28 <br/ ><br>;Proportion of patients on mechanical ventilationTimepoint: Day 7