CTRI/2020/04/024706
Completed
Phase 2
Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients: A Pilot Randomized Controlled Trial.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- Institute of Liver and Biliary Sciences
- Enrollment
- 29
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\-
- •1\.Respiratory distress, RR \>\=30 beats/min
- •2\.Oxygen saturation level less than 93% in resting state
- •3\.Partial pressure of oxygen (PaO2\)/oxygen concentration (FiO2\) \<\= 300 mmHg.
- •4\.Lung infiltrates \> 50% within 24 to 48 hours
- •5\. Very sick (on ventilator) and patients with co\-morbidities such as patients with known co\-
- •morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease\-structural or valvular heart
- •6\. Patient presenting with multi organ failure or requiring mechanical ventilation.
- •7\. Minimum age: 18 yrs to maximum age\- no limit as per recent protocol amendment.
- •Known case of recovered COVID\-19 Infection, and
Exclusion Criteria
- •Patients with age less than 18 years.
- •Pregnancy
- •Individual with HIV and Hepatitis
- •Morbid Obesity BMI \>35 kg/m2
- •Extremely moribund patients with an expected life expectancy of less than
- •Failure to give informed consent from the patient or family members.
- •Hemodynamic instability requiring vasopressors.
- •Previous allergic history to plasma.
- •Donors age \< 18 and \>\=60 years old
- •Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under
Outcomes
Primary Outcomes
Not specified
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