Effects of Covieshield vaccine on Liver cirrhosis patients

Not Applicable

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2021/03/032158
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

The following patients will be enrolled in the study under Group 1:

1) Evidence of liver cirrhosis established during the clinical investigations and/or hospital stay, as evidenced by clinical, endoscopic, radiological and/or histological criteria.

2) Baseline Negative SARS-COV19 IgG neutralizing antibodies.

The following patients (healthy controls) will be enrolled in the study:

1) Baseline Negative SARS-COV19 IgG neutralizing antibodies

2) No previous COVID-19 infection

3) No major respiratory, cardiac comorbid illnesses or malignancy or immunosuppressed state

Exclusion Criteria

1.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.

2.Prior or concomitant vaccine therapy for COVID-19

3.ICU patients

4.Hemodynamically unstable patients, shock

5.Significant encephalopathy, acute kidney injury

6.Documented or suspected sepsis including chest infection

7.ACLF (Acute on Chronic Liver Failure)

8.Significant cardiac or respiratory co-morbidities

9.Known allergy to vaccination

10.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).

11.History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 (Covishield) vaccine.

12.Any history of angioedema.

13.Any history of anaphylaxis.

14.Pregnancy, lactation or willingness/intention to become pregnant during the study.

15.Any other serious chronic illness requiring hospital specialist supervision.

16.Currently or in last 3 weeks have: fever/cough/sorethroat/rhinorrhea/hemoptysis/breathlessness/chest pain/myalgia/nausea/vomiting/diarrhea/abdominal pain/loss of taste.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy, safety and tolerability of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis. <br/ ><br>Efficacy of the the vaccine is defined as proportion of patients with presence of antibodies titres compared with the control group.Timepoint: 6 months