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

Critical Illness Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05331742
• Other study ID #: CSHNepal
• Status: Not yet recruiting
• Start date: April 15, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2022
• Source: Civil Service Hospital of Nepal
• Contact: Deepak Bhandari, MD
• Phone: +9779851123608
• Email: drbhandari.crc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Critical Illness

Intervention

Drug:
• Vaccine
patients who have received vaccine against coronavirus disease infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Civil Service Hospital of Nepal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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