Status:
COMPLETED
Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Currently, no effective treatments are available for the COVID-19 pandemic, which is related to more than 70,000 deaths all over the world. Scientists and Researchers are working on many aspects of tr...
Detailed Description
For Donors: Microtiter plates will be coated overnight at 4°C with 4 μg/mL recombinant SARS-CoV-2 RBD (receptor binding domain) proteins (50 μL per well). The plates will be washed 3 times with phosp...
Eligibility Criteria
Inclusion
- \-
- Recipient:
- 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-
- Respiratory distress, RR ≥30 beats/min
- Oxygen saturation level less than 93% in resting state
- Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg.
- Lung infiltrates \> 50% within 24 to 48 hours
- 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 disease)
- Patient presenting with multi organ failure or requiring mechanical ventilation.
- Donor:
- Known case of recovered COVID-19 Infection, and
- Complete resolution of symptoms at least 28 days prior to donation or 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, And Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens \> 24 hrs apart (WHO-CDC guideline).
- 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).
- Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs \& Cosmetics Act and Rules 1945, amended 11.03.2020.
Exclusion
- \- Recipient
- 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 24 hours.
- Failure to give informed consent from the patient or family members.
- Hemodynamic instability requiring vasopressors.
- Previous allergic history to plasma.
- Donor:
- Donors age \< 18 \& ≥60 years old
- Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under the Drugs \& Cosmetics Act and Rules 1945, amended 11.03.2020.
- Females who have been pregnant and previously transfused donors (to prevent TRALI).
- Donors who have taken steroids during treatment for COVID-19.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04346446
Start Date
April 20 2020
End Date
May 30 2020
Last Update
June 12 2020
Active Locations (2)
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1
Maulana Azad medical College
New Delhi, National Capital Territory of Delhi, India, 110002
2
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070