Coronavirus InfectionsNCT05331742
Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in Critical Care Unit.
An observational study of Coronavirus Infections and Critical Illness, run by Civil Service Hospital of Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections, Critical Illness
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients proven to have covid 19 infection patients more than 18 years of age patients admitted to critical care unit
Who cannot join
- patient below 18 years of age patients who do not have covid 19 infection
Trial locations and contacts
No sites are listed yet.
About this study
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.
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 .
Read the 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.
- Conditions
- Coronavirus Infections, Critical Illness
- Being tested
- Vaccine
- Medical subject headings
- Coronavirus Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineDrug
patients who have received vaccine against coronavirus disease infection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: with 12 weeks from the date of critical care unit admission
Secondary outcomes (1)
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)
Measured: within 24 weeks form the date of critical care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start15 Apr 2022 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Civil Service Hospital of Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Deepak Bhandari, Civil Service Hospital of Nepal
- Investigators
- Deepak Bhandari, MD, Principal investigator, Civil Services hospital , Kathmandu Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331742
- Sponsor's protocol ID
- CSHNepal
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05331742
- Acronym / sponsor ID
- CSHNepal
- Conditions
- Coronavirus Infections, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Civil Service Hospital of NepalOther government
- Study start
- 15 Apr 2022 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated | – | Drug: Vaccinepatient 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients proven to have covid 19 infection patients more than 18 years of age patients admitted to critical care unit
Key exclusion criteria (1 listed)
- patient below 18 years of age patients who do not have covid 19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccinepatients who have received vaccine against coronavirus disease infection | Drug | vaccinated |
Primary outcome
Mortality
Time frame: within 12 weeks from the date of critical care unit admission
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
length of icu stay
Time frame: with 12 weeks from the date of critical care unit admission
difference in length of stay between vaccinated and unvaccinated population admitted to critical care unit after being infected with coronavirus disease
1 secondary outcome
difference in mortality due to associated co-morbidity
Time frame: within 24 weeks form the date of critical care unit admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Bhandari, MD principal investigator
Civil Services hospital , Kathmandu Nepal
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections and Critical Illness, run by Civil Service Hospital of Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deepak Bhandari, MD (+9779851123608, drbhandari.crc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: within 12 weeks from the date of critical care unit admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.