SARS CoV 2 InfectionNCT05244343
I VACCIN Hospitalization of COVID-19 Patients
An observational study of SARS CoV 2 Infection and COVID-19, run by Eshmoun Clinical Research Center at 1 site in Tunisia.
Trial summary
A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection, COVID-19
- How many people
- 1,096 participants
- Where
- 1 siteTunisia
- Study dates
- 25 Jan 2022to 10 Mar 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: Patients hospitalized due to COVID-19 in ICU or medical units, who are ≥ 18 years old during the period extended from January 1st to March 3rd.
Who may be able to join
- Male and Female ≥ 18 years
- Confirmed COVID-19 patients hospitalized in ICU and Medical Units during the period of the study from January 1st to March 3rd.
Who cannot join
- Subjects vaccinated outside Tunisia
- Subjects <18 years
- Not confirmed COVID-19
- Not hospitalized patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients
A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients
Read the detailed description
Transversal National multicenter non interventional on the COVID-19 vaccines
- Period of hospitalization: from January 1st to March 3rd, 2022
- Recruitment duration: 37 days
- Total study duration: 44 days
- Conditions
- SARS CoV 2 Infection, COVID-19
- Keywords
- COVID-19, Vaccination, Hospitalization
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 not vaccinated patients hospitalized in ICU
Rate of non vaccinated patients who were hospitalized in ICU due to COVID-19 compared to all patients hospitalized due to COVID-19
Measured: From January 1st to February 15th
Rate of COVID-19 not fully vaccinated patients hospitalized in ICU
Rate of not fully vaccinated patients who were hospitalized in ICU due to COVID-19 compared to the total number of Hospitalized patients
Measured: From January 1st to February 15th
Secondary outcomes (3)
Rate of COVID-19 not vaccinated patients hospitalized in Medical Units
Rate of non vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19
Measured: From January 1st to February 15th
Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units
Rate of not fully vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19
Measured: From January 1st to February 15th
Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine
Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine received
Measured: From January 1st to February 15th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start25 Jan 2022
- Primary completion3 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,096 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eshmoun Clinical Research Center
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mariem Melliti, Study director, Eshmoun Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244343
- Sponsor's protocol ID
- I VACCIN
- Status last verified
- Mar 2022
- First submitted
- 16 Feb 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05244343
- Acronym / sponsor ID
- I VACCIN
- Conditions
- SARS CoV 2 Infection, COVID-19
- Keywords
- COVID-19, Vaccination, Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,096 participants (actual)
- Lead sponsor
- Eshmoun Clinical Research CenterResearch network
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 17 Feb 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.
A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients
Detailed description
Transversal National multicenter non interventional on the COVID-19 vaccines
- Period of hospitalization: from January 1st to March 3rd, 2022
- Recruitment duration: 37 days
- Total study duration: 44 days
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized due to COVID-19 in ICU or medical units, who are ≥ 18 years old during the period extended from January 1st to March 3rd.
Key inclusion criteria (2 listed)
- Male and Female ≥ 18 years
- Confirmed COVID-19 patients hospitalized in ICU and Medical Units during the period of the study from January 1st to March 3rd.
Key exclusion criteria (4 listed)
- Subjects vaccinated outside Tunisia
- Subjects <18 years
- Not confirmed COVID-19
- Not hospitalized patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of COVID-19 not vaccinated patients hospitalized in ICU
Time frame: From January 1st to February 15th
Rate of non vaccinated patients who were hospitalized in ICU due to COVID-19 compared to all patients hospitalized due to COVID-19
Rate of COVID-19 not fully vaccinated patients hospitalized in ICU
Time frame: From January 1st to February 15th
Rate of not fully vaccinated patients who were hospitalized in ICU due to COVID-19 compared to the total number of Hospitalized patients
3 secondary outcomes
Rate of COVID-19 not vaccinated patients hospitalized in Medical Units
Time frame: From January 1st to February 15th
Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units
Time frame: From January 1st to February 15th
Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine
Time frame: From January 1st to February 15th
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Mariem Melliti study director
Eshmoun Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection and COVID-19, run by Eshmoun Clinical Research Center at 1 site in Tunisia.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of COVID-19 not vaccinated patients hospitalized in ICU (time frame: From January 1st to February 15th). 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 1 Apr 2022.