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

NCT05331742 | Unknown DMC

• 1 other identifier: CSHNepal
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Coronavirus Infections; Critical Illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• difference in mortality due to associated co-morbidity

  within 24 weeks form the date of critical care unit admission

Study Arms (2)

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

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

Interventions

Vaccine DRUG

patients who have received vaccine against coronavirus disease infection

vaccinated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Civil Service Hospital of Nepal: lead

MeSH Terms

Conditions

Coronavirus Infections; Critical Illness

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Deepak Bhandari, MD

  Civil Services hospital , Kathmandu Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepak Bhandari, MD

CONTACT

+9779851123608; drbhandari.crc@gmail.com

Aalok Parajuli, mbbs

CONTACT

+9779841710564; livethenature1000@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 18, 2022
• Study Start: April 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: June 1, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04