Status:
UNKNOWN
Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), had caused widespread impact on health, including substantial mortality among those with pre-existing health ...
Detailed Description
* Study population: Group 1: Liver Cirrhosis Group 2: Control Group (Healthy controls) * Study design: A Single Centre, Pilot Study,Adaptive Clinical Trial * Study period: 1 year, Enrolment Period: Ma...
Eligibility Criteria
Inclusion
- The following patients will be enrolled in the study under Group 1:
- Age greater than and equal to 18 years
- Evidence of liver cirrhosis established during the clinical investigations and/or hospital stay, as evidenced by clinical, endoscopic, radiological and/or histological criteria.
- Baseline Negative SARS-COV19 IgG neutralizing antibodies
- The following patients (healthy controls) will be enrolled in the study:
- Age greater than and equal to 18 years
- Baseline Negative SARS-COV19 IgG neutralizing antibodies
- No previous COVID-19 infection
- No major respiratory, cardiac comorbid illnesses or malignancy or immunosuppressed state
Exclusion
- Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine.
- Prior or concomitant vaccine therapy for COVID-19
- ICU patients
- Hemodynamically unstable patients, shock
- Significant encephalopathy, acute kidney injury
- Documented or suspected sepsis including chest infection
- ACLF (Acute on Chronic Liver Failure)
- Significant cardiac or respiratory co-morbidities
- Known allergy to vaccination
- Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
- History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 (Covishield) vaccine.
- Any history of angioedema.
- Any history of anaphylaxis.
- Pregnancy, lactation or willingness/intention to become pregnant during the study.
- Any other serious chronic illness requiring hospital specialist supervision.
- Currently or in last 3 weeks have: fever/cough/sorethroat/rhinorrhea/hemoptysis/breathlessness/chest pain/myalgia/nausea/vomiting/diarrhea/abdominal pain/loss of taste
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2022
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT04794946
Start Date
March 19 2021
End Date
March 19 2022
Last Update
June 23 2021
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070