Status:
UNKNOWN
Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
Lead Sponsor:
Max Healthcare Insititute Limited
Conditions:
COVID 19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respirato...
Detailed Description
The study will be conducted over the period of one year on 100 Hospitalized, COVID-19 patients, fulfill the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilitie...
Eligibility Criteria
Inclusion
- 1\. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age \> 18 years 3. Written informed consent 4. Has any of the two
- PaO2/ FiO2 \<300
- Respiratory Rate \> 24/min and SaO2 \< 93% on room air
- Or In case of Severe or immediately life-threatening COVID-19, for example:
- a. Severe disease is defined as: i. dyspnea, ii. respiratory frequency ≥ 30/min, iii. blood oxygen saturation ≤ 93%, iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or v. lung infiltrates \> 50% within 24 to 48 hours b. Life-threatening disease is defined as: i. respiratory failure, ii. septic shock, and/or iii. multiple organ dysfunction or failure
Exclusion
- 1\. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 5. Participating in any other clinical trial 6. Clinical status precluding infusion of blood products
Key Trial Info
Start Date :
May 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04374487
Start Date
May 9 2020
End Date
August 9 2021
Last Update
July 22 2020
Active Locations (1)
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1
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, India, 110017