Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Convalescent Plasma with Standard of Care: Convalescent Plasma: Dose-250 ml Frequency - 2 doses on consecutive days Duration -Start by day 3 of symptom onset (of severe COVID-19 as in i
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Proportion of patients on mechanical ventilationTimepoint: Day 7 | — |
Countries
India
Contacts
Public ContactDr Meenu Bajpai
Institute of Liver and Biliary Sciences
Outcome results
None listed