Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis

NCT04794946 | Unknown DMC

• 1 other identifier: ILBS-COVID-05
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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 conditions including cirrhosis. Patients with liver cirrhosis are at increased risk of severe disease and death from the virus infection that causes COVID-19 and are therefore a priority for immunization, should an efficacious vaccine be developed. Currently, there are no specific treatments available against COVID-19 and cirrhosis patients are a priority group for vaccination.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by proportion of patients with presence of antibodies titres compared with the control group.

  6 months

• To evaluate the safety/tolerability of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis as measured by comparison of safety profile of AZD1222 (Covishield) in both the groups

  Safety/tolerability will be assessed by collecting the adverse event data,events of decompensation and new onset of COVID 19 infection by RTPCR.

  6 months

Secondary Outcomes (12)

• To study the profile of immune cells after vaccination.

  1 year

• To study the profile of cytokine signatures after vaccination.

  1 year

• The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.

  1 year

• The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.

  1 year

• The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention.

  1 year

Study Arms (2)

Liver Cirrhosis

EXPERIMENTAL

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

Biological: Covishield

Non Liver Cirrhosis (Healthy Control)

ACTIVE COMPARATOR

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

Biological: Covishield

Interventions

Covishield BIOLOGICAL

2 IM doses (0.5 mL) of AZD1222(Covishield) at Day 0 and after 6-8 weeks of first dose (Day 42-56 days). This schedule will be followed for the first 100 participants, following which vaccination schedule as per the prevailing Government protocols shall be followed as a part of Adaptive Clinical Trial.

Liver Cirrhosis; Non Liver Cirrhosis (Healthy Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

ChAdOx1 nCoV-19

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Central Study Contacts

Dr Shantan Venishetty, MD

CONTACT

01146300000; venishantan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: March 19, 2021
• Primary Completion: March 19, 2022
• Study Completion: March 19, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-03

Locations

IN (1)