Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in Critical Care Unit.

Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients Admitted to Critical Care Unit in a Tertiary Care Hospital of Kathmandu, Nepal.

Corona virus disease has been a pandemic since its beginning. The problem has scaled to break health care system of multiple countries. One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing outcome among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital, Kathmandu , Nepal .

Study Overview

• Status: Not yet recruiting
• Conditions: Coronavirus Infections; Critical Illness
• Intervention / Treatment: Drug: Vaccine

Detailed Description

Coronavirus disease has been a pandemic since its beginning. The problem has scaled up and health care system of multiple countries have reached to a breaking point . One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing difference in outcome with regard to mortality and length of critical care unit stay among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital , Kathmandu , Nepal.

Since different groups of population received different vaccine according to age profession and other factors investigators are trying to study the effectiveness of vaccine with regards to type of vaccine.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Aalok Parajuli, mbbs; Phone Number: +9779841710564; Email: livethenature1000@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients who had covid 19 infection and have been admitted to critical care unit will be enrolled in the study.

Patient who have received vaccination against covid 19 infection yet are covid positive will be compared with patients who have not received covid 19 infection and have active covid 19 infection

Description

Inclusion Criteria:

patients proven to have covid 19 infection patients more than 18 years of age patients admitted to critical care unit

Exclusion Criteria:

• patient below 18 years of age patients who do not have covid 19 infection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vaccinated; patient between age 18 and above who have received a complete dose of coronavirus disease vaccine patient who has been admitted to critical care unit due to corona virus disease infection	Drug: Vaccine; patients who have received vaccine against coronavirus disease infection
unvaccinated; patients between age 18 and above who has been admitted to critical care unit due to coronavirus disease infection and admitted to critical care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	the primary outcome to be measured will be difference in mortality among two groups (vaccinated and unvaccinated) of coronavirus infected patients admitted in critical care unit	within 12 weeks from the date of critical care unit admission
length of icu stay	difference in length of stay between vaccinated and unvaccinated population admitted to critical care unit after being infected with coronavirus disease	with 12 weeks from the date of critical care unit admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in mortality due to associated co-morbidity	difference in mortality due to associated co-morbidity will be compared among both the group (vaccinated and unvaccinated)	within 24 weeks form the date of critical care unit admission

Collaborators and Investigators

• Sponsor: Civil Service Hospital of Nepal
• Investigators: Principal Investigator: Deepak Bhandari, MD, Civil Services hospital , Kathmandu Nepal

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 15, 2022
• Primary Completion (ANTICIPATED): April 15, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (ACTUAL): April 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Coronavirus Infections; Critical Illness
• Other Study ID Numbers: CSHNepal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No