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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

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

Conditions
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Coronavirus Infections, Critical Illness

Intervention / Treatment
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* Drug: Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vaccinated<br>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<br>* patients who have received vaccine against coronavirus disease infection<br>|
| unvaccinated<br>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?
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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 |