Clinical trial NCT05331742: Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in Critical Care Unit.
Official title: Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients Admitted to Critical Care Unit in a Tertiary Care Hospital of Kathmandu, Nepal.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infections
Critical Illness
Lead sponsor: Civil Service Hospital of Nepal
Sponsor class: OTHER_GOV
First posted: 2022-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: within 12 weeks from the date of critical care unit admission
measure: length of icu stay
timeFrame: with 12 weeks from the date of critical care unit admission
Secondary outcomes:
measure: difference in mortality due to associated co-morbidity
timeFrame: within 24 weeks form the date of critical care unit admission
Other outcomes:
Locations:
Study officials:
affiliation: Civil Services hospital , Kathmandu Nepal
name: Deepak Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
References: