Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05851820
Other study ID # SRouis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2020
Est. completion date August 31, 2021

Study information

Verified date May 2023
Source Faculty of Medicine, Sousse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19. Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.


Description:

The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections. Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19. Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.


Recruitment information / eligibility

Status Completed
Enrollment 866
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive. Exclusion Criteria: - the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
comparison of outcomes/exposure
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Locations

Country Name City State
Tunisia Kairouan Kairouan

Sponsors (1)

Lead Sponsor Collaborator
Sana Rouis

Country where clinical trial is conducted

Tunisia, 

References & Publications (5)

Al-Salameh A, Lanoix JP, Bennis Y, Andrejak C, Brochot E, Deschasse G, Dupont H, Goeb V, Jaureguy M, Lion S, Maizel J, Moyet J, Vaysse B, Desailloud R, Ganry O, Schmit JL, Lalau JD. Characteristics and outcomes of COVID-19 in hospitalized patients with and without diabetes. Diabetes Metab Res Rev. 2021 Mar;37(3):e3388. doi: 10.1002/dmrr.3388. Epub 2020 Aug 18. — View Citation

Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17. Erratum In: Lancet Diabetes Endocrinol. 2020 Oct;8(10):e5. Lancet Diabetes Endocrinol. 2020 Nov;8(11):e6. — View Citation

Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8. — View Citation

Wu J, Zhang J, Sun X, Wang L, Xu Y, Zhang Y, Liu X, Dong C. Influence of diabetes mellitus on the severity and fatality of SARS-CoV-2 (COVID-19) infection. Diabetes Obes Metab. 2020 Oct;22(10):1907-1914. doi: 10.1111/dom.14105. Epub 2020 Jul 7. — View Citation

Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Admission to Intensive Care Units patients who were transferred to ICU 7 days
Primary death patients who were dead 7 days
Primary overall length of hospital stay length of hospital stay from admission to discharge (or transfer or death) 7 days
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure