COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43039

Dr Meenu Bajpai

meenubajpai@hotmail.com

2020-04-17

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Recipient: <br/ >Severe COVID -19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ >1. Respiratory distress, RR â?¥30 beats/min <br/ >2. Oxygen saturation level less than 93% in resting state <br/ >3. Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) â?¤ 300 mmHg. <br/ >4. Lung infiltrates > 50% within 24 to 48 hours <br/ >5. Very sick (on ventilator) and patients with co-morbidities such as patients with known co- <br/ > morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease-structural or valvular heart <br/ > disease) <br/ >6. Patient presenting with multi organ failure or requiring mechanical ventilation. <br/ >7. Minimum age: 18 yrs to maximum age- no limit as per recent protocol amendment. <br/ > <br/ >Donor: <br/ >â?¢ Known case of recovered COVID-19 Infection, and <br/ >â?¢ Complete resolution of symptoms at least 28 days prior to donation or <br/ >Complete resolution of symptoms at least 14 days prior to donation and negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from the blood, <br/ > And <br/ >Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens > 24 hrs apart (WHO-CDC guideline). <br/ >â?¢ Donor Plasma after 2 negative tests and 2 weeks of remaining asymptomatic, without antibody titre & presence of IgG/IgM antibodies to COVID-19 by serological as per manufacturers instructions. Donors negative for these will be deferred). <br/ >â?¢ Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.

Recipient <br/ >â?¢ Patients with age less than 18 years. <br/ >â?¢ Pregnancy <br/ >â?¢ Individual with HIV and Hepatitis <br/ >â?¢ Morbid Obesity BMI >35 kg/m2 <br/ >â?¢ Extremely moribund patients with an expected life expectancy of less than <br/ > 24 hours. <br/ >â?¢ Failure to give informed consent from the patient or family members. <br/ >â?¢ Hemodynamic instability requiring vasopressors. <br/ >â?¢ Previous allergic history to plasma. <br/ > <br/ >Donor: <br/ >â?¢ Donors age < 18 and â?¥60 years old <br/ >â?¢ Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under <br/ > the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020. <br/ >â?¢ Females who have been pregnant and previously transfused donors (to <br/ > prevent TRALI). <br/ >â?¢ Donors who have taken steroids during treatment for COVID-19.

2

Institute of Liver and Biliary Sciences

18

99

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

Proportion of patients remaining free of mechanical ventilation in both groupsTimepoint: day 7

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

Phase 2

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