COVID-19 Pandemic4CNCT05498324
External Validation of the 4C Mortality Score for Hospitalised Patients With COVID-19 in a Tunisian Cohort
An observational study of COVID-19 Pandemic, run by University of Monastir at 1 site in Tunisia.
Trial summary
Risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C mortality score, originally developed in the United Kingdom, for a tunisian population, and to examine its performance over time. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19 Pandemic
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2020to 30 Apr 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in this study had a positive SARS-CoV-2 PCR test result and were admitted through the emergency department one of the participating centers, between november 1st,2020 to December 1st, 2021.
Who may be able to join
- patients ≥18 years old
- admitted to one of the participating hospitals with a confirmed case of COVID-19 defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations
Who cannot join
- under the age of 18
- Incomplete electronic records were excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C mortality score, originally developed in the United Kingdom, for a tunisian population, and to examine its performance over time.
Read the detailed description
Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) can progress to acute respiratory distress syndrome, multiorgan failure, and death in some cases. The clinical presentation and progression of COVID-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. A simple, validated prognostic tool using data that is available at presentation can help clinicians better prognosticate and support clinical decision-making . Numerous tools to predict mortality in COVID-19 patients have been developed, but many are limited due to small derivation cohort sizes and/or inadequate validation.
The 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability.
The objective of this study was to validate the 4 C Mortality risk score to predict in-hospital mortality among adults hospitalised with COVID-19 in a Tunisian cohort.
.
- Conditions
- COVID-19 Pandemic
- Keywords
- covid-19, SARS-COV2, 4c score, validation
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was all-cause in-hospital mortality rate
The primary outcome was all-cause in-hospital mortality rate
Measured: 30 days after inclusion
Secondary outcomes (2)
ICU admission rate
ICU admission rate
Measured: 30 days after inclusion
combined outcome
all-cause in-hospital mortality and/or ICU admission
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Nov 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Bel Haj Ali Khaoula, MD, Study director, CHU Fattouma Bourguiba Monastir, service des urgences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498324
- Sponsor's protocol ID
- 4C Score
- Acronym
- 4C
- Status last verified
- May 2023
- First submitted
- 9 Aug 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon AJ, Govindarajan P, Bennett CL, Matheson L, Kohn MA, Camargo C, Kline J. External validation of the 4C Mortality Score for hospitalised patients with COVID-19 in the RECOVER network. BMJ Open. 2022 Apr 21;12(4):e054700. doi: 10.1136/bmjopen-2021-054700.
PubMed 35450898Knight SR, Gupta RK, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LCW, Openshaw PJM, Baillie JK, Docherty A, Semple MG, Noursadeghi M, Harrison EM; ISARIC Coronavirus Clinical Characterisation Consortium (ISARIC4C) Investigators; ISARIC4C investigators. Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol. Thorax. 2022 Jun;77(6):606-615. doi: 10.1136/thoraxjnl-2021-217629. Epub 2021 Nov 22.
PubMed 34810237
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the 4C Mortality Score for Hospitalised Patients With COVID-19 in a Tunisian Cohort
- ClinicalTrials.gov ID
- NCT05498324
- Acronym / sponsor ID
- 4C / 4C Score
- Conditions
- COVID-19 Pandemic
- Keywords
- covid-19, SARS-COV2, 4c score, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 12 Aug 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.
Risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C mortality score, originally developed in the United Kingdom, for a tunisian population, and to examine its performance over time.
Detailed description
Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) can progress to acute respiratory distress syndrome, multiorgan failure, and death in some cases. The clinical presentation and progression of COVID-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. A simple, validated prognostic tool using data that is available at presentation can help clinicians better prognosticate and support clinical decision-making . Numerous tools to predict mortality in COVID-19 patients have been developed, but many are limited due to small derivation cohort sizes and/or inadequate validation.
The 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability.
The objective of this study was to validate the 4 C Mortality risk score to predict in-hospital mortality among adults hospitalised with COVID-19 in a Tunisian cohort.
.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in this study had a positive SARS-CoV-2 PCR test result and were admitted through the emergency department one of the participating centers, between november 1st,2020 to December 1st, 2021.
Key inclusion criteria (2 listed)
- patients ≥18 years old
- admitted to one of the participating hospitals with a confirmed case of COVID-19 defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations
Key exclusion criteria (2 listed)
- under the age of 18
- Incomplete electronic records were excluded from the analysis.
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
The primary outcome was all-cause in-hospital mortality rate
Time frame: 30 days after inclusion
The primary outcome was all-cause in-hospital mortality rate
2 secondary outcomes
ICU admission rate
Time frame: 30 days after inclusion
combined outcome
Time frame: 30 days after inclusion
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 16 May 2023.
- Background: PubMed 35450898Gordon AJ, Govindarajan P, Bennett CL, Matheson L, Kohn MA, Camargo C, Kline J. External validation of the 4C Mortality Score for hospitalised patients with COVID-19 in the RECOVER network. BMJ Open. 2022 Apr 21;12(4):e054700. doi: 10.1136/bmjopen-2021-054700.
- Background: PubMed 34810237Knight SR, Gupta RK, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LCW, Openshaw PJM, Baillie JK, Docherty A, Semple MG, Noursadeghi M, Harrison EM; ISARIC Coronavirus Clinical Characterisation Consortium (ISARIC4C) Investigators; ISARIC4C investigators. Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol. Thorax. 2022 Jun;77(6):606-615. doi: 10.1136/thoraxjnl-2021-217629. Epub 2021 Nov 22.
- 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.
Bel Haj Ali Khaoula, MD study director
CHU Fattouma Bourguiba Monastir, service des urgences
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 COVID-19 Pandemic, run by University of Monastir 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 2 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 16 May 2023. 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?
The primary outcome was all-cause in-hospital mortality rate (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05498324, which also lists 2 linked publications.
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 16 May 2023.