COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44478

Dr Meenu Bajpai

meenubajpai@hotmail.com

2020-06-11

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Recipient Inclusion Criteria: <br/ > <br/ >- 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- <br/ > <br/ >Patients on ventilator (in last 24 hours) <br/ >Respiratory distress, RR greater than or equal to 30 beats/min <br/ >Oxygen saturation level less than 90 % in resting state <br/ >Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ >Lung infiltrates > 50% within 24 to 48 hours <br/ >Donor Inclusion Criteria for Plasmapheresis <br/ > <br/ >Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ >Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ >Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.

Recipient Exclusion Criteria: <br/ > <br/ >Patient/ family members who do not give consent to participate in the study. <br/ >Patients with age less than 18 years <br/ >Patients presenting with multi-organ failure <br/ >Pregnancy <br/ >Individuals with HIV and Viral Hepatitis and Cancer <br/ >Extremely moribund patients with an expected life expectancy of less than 24 hours <br/ >Hemodynamic instability requiring vasopressors <br/ >Previous history of allergy to plasma <br/ >Cirrhosis <br/ >Severe renal impairment with GFR < 30ml/min or recipients of RRT, peritoneal dialysis <br/ >Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable Angina <br/ >Donors Exclusion Criteria: <br/ > <br/ >Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under <br/ >the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ >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) <br/ >Donors who have taken steroids during treatment for COVID-19

2

Institute of Liver and Biliary Sciences

18

99

India

Severe disease at enrollment

6: Severe disease at enrollment

400

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/ >Timepoint: Day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]