Condition category
Infections and Infestations
Date applied
25/12/2020
Date assigned
30/12/2020
Last edited
31/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

The prevalence in the general population of obesity, diabetes, hypertension (high blood pressure) and malnutrition (poor diet) is high, therefore it is useful to investigate the clinical significance when these conditions are present in patients with COVID-19.

Who can participate?
Patients admitted to different Italian hospitals for serious COVID-19 disease.

What does the study involve?
The study will examine the medical records of patients with serious COVID-19 to find health and lifestyle factors that are related to severe COVD-19. If the records do not contain all the required information the participant may have a telephone interview to gather missing information.

What are the possible benefits and risks of participating?
The benefit of participating is helping with the research. This study could provide useful information for the prognosis and treatment of this disease and could promote better management of the disease. There are no risks associated with participating.

Where is the study run from?
University of Palermo (Italy).

When is the study starting and how long is it expected to run for?
December 2020 to June 2021.

Who is funding the study?
University of Palermo (Italy)

Who is the main contact?
Prof. Silvio Buscemi, MD, silvio.buscemi@unipa.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Silvio Buscemi

ORCID ID

http://orcid.org/0000-0003-0730-7649

Contact details

University of Palermo - PROMISE department
Unit of Clinical Nutrition; AOU Policlinico "P. Giaccone"
Piazza delle Cliniche
2
Palermo
90127
Italy
+39 91 6552251
silvio.buscemi@unipa.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

02/2020

Study information

Scientific title

Malnutrition, obesity, diabetes, hypertension and severe COVID-19 in Italy

Acronym

MODIeCOSe in Italia

Study hypothesis

The prevalence in the general population of obesity, diabetes, hypertension and malnutrition is high. It is useful to investigate the association of these diseases with severe COVID-19 to improve prognosis and treatment in the hospital environment.

Ethics approval

Approved 18/12/2020, Palermo 1 Ethics Committee (AOU Policlinico "P. Giaccone"; via del vespro 129 -90127 Palermo, Italy; +39 91 6555210/5211; bioetica@policlinico.pa.it), ref: 11/2020

Study design

Longitudinal observational retrospective multicenter study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not applicable (retrospective study)

Condition

To investigate the association between obesity, diabetes, hypertension and malnutrition with severe COVID-19 outcome (SARS-CoV-2 infection) in hospital settings

Intervention

Patients must fulfil the inclusion criteria for entry. Data will be extracted from the medical records and databases of each center. In the case of patients who have previously given written consent to be contacted, the evaluation/completion of any missing data can be ensured through a telephone interview with the patient or caregiver. Data will be made anonymous and identified through a code. The code will be linked to each patient's medical record in a guarded list of each center. The data will flow into a single Excel database at the main center.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured using patient records (and a telephone interview if required) at a single time point:
1. Demographics
1.1. Age
1.2. Ethnicity
1.3. Current or previous work activity
1.4. Self-sufficient patient (yes/no)
1.5. In a nursing home (yes/no)
1.6. Caregiver (yes/no)
2. Hospitalisation and outcome
2.1. Duration of hospitalization (days)
2.2. Transferred to resuscitation (yes/no)
2.3. Recovery (yes/no)
3. Vaccinated for influenza or pneumococcus (yes/no)
4. Anthropometric data
4.1. Height (cm)
4.2. Weight (kg)
4.3. Waist circumference (cm)
5. Medication history before admission
6. Hematology at entry and near discharge
6.1. Leukocytes (x10(9)/L)
6.2. Red blood cells (x10(12)/L)
6.3. Hemoglobin - HB (g/dl)
6.4. Hematocrit - Hct (%)
6.5. MCV (f/L)
6.6. Platelets (x10(9)/L)
6.7. Lymphocytes (x10(9)/L)
6.8. Neutrophils (x10(9)/L)
7. Lab values at entry and near discharge
7.1. Blood glucose (mg/dl)
7.2. HbA1c (%)
7.3. Creatinine (mg/ml)
7.4. Total cholesterol (mg/dl)
7.5. HDL cholesterol (mg/dl)
7.6. Triglycerides (mg/dl)
7.7. ALT (U/L)
7.8. AST (U/L)
7.9. GGT (U/L)
7.10. Albunemia (%)
7.11. Total proteins (g/dl)
7.12. eGFR IL-6 (pg/ml)
7.13. C-reactive protein (mg/dl)
7.14. CK (mg/dl)
7.15. LDH (U/L)
7.16. Ferritin (ng/ml)
8. Blood gas values at entry and near discharge
8.1. PaO2
8.2. PaCO2
8.3. FiO2
8.4. PH
8.5. Lactates
8.6. HCO3- SO2
8.7. Oxygen therapy (y/n)
8.8. PEEP
9. Therapy during stay
9.1. Paracetamol
9.2. Cortisone
9.3. Antibiotic (Macrolide [azithromycin], cephalosporin, quinolone)
9.4. Heparin
9.5. Chloroquine/Hydroxychloroquine
9.6. Cholecalciferol
9.7. Artificial nutrition
9.8. Other
10. Previous pathologies
10.1. Diabetes mellitus
10.2. Arterial hypertension
10.3. Ischemic heart disease
10.4. Chronic heart failure
10.5. Smoking
10.6. Atrial fibrillation
10.7. Neoplasms
10.8. Chronic obstructive pulmonary disease
10.9. Bronchial asthma
10.10. Chronic renal failure
10.11. Stroke
10.12. Pulmonary embolism
10.13. Congenital heart disease
10.14. Other

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

18/12/2020

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Hospitalized patients
2. Proven COVID-19 disease
3. Aged 18 and above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

>2,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Italy

Trial participating centre

University of Palermo
Department PROMISE Unit of Clinical Nutrition AOU Policlinico “P. Giaccone” Piazza delle Cliniche, 2
Palermo
90127
Italy

Trial participating centre

Ospedale Sant’Anna di Como
Struttura Semplice Dipartimentale di Endocrinologia Nutrizione Clinica e Obesità Via Ravona
San Fermo della Battaglia (CO)
22042
Italy

Trial participating centre

IRCCS Policlinico San Donato
Servizio di Nutrizione Clinica e Prevenzione Cardiovascolare Piazza Edmondo Malan, 2
San Donato Milanese (MI)
20097
Italy

Trial participating centre

Università di Padova
Clinica Medica 3 Azienda Ospedaliera Università Padova Via Giustiniani, 2
Padova (PD)
35128
Italy

Trial participating centre

Università di Pisa
UOC di Endocrinologia Azienda Ospedaliero-Universitaria Pisana Via Paradisa, 2
Pisa
56124
Italy

Trial participating centre

Università di Pisa
SD Medicina Interna ad indirizzo Immuno-Endocrino Azienda Ospedaliero-Universitaria Pisana Via Paradisa, 2
Pisa
56124
Italy

Trial participating centre

Università degli Studi di Roma “Tor Vergata”
Dipartimento di Medicina dei Sistemi Via Montpellier, 1
Roma
00133
Italy

Trial participating centre

Università “Sapienza” di Roma
Dipartimento di Medicina Sperimentale UOC Diabetologia Universitaria Ospedale Santa Maria Goretti Via Guido Reni
Latina
04100
Italy

Trial participating centre

Università Magna Graecia di Catanzaro
UO Malattie Infettive e tropicali - Azienda Ospedaliero Universitaria "Mater Domini" Viale Tommaso Campanella, 115
Catanzaro
88100
Italy

Trial participating centre

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
PO Garibaldi-Nesima - UOC Geriatria Via Palermo, 636
Catania
95122
Italy

Trial participating centre

Università di Palermo
Dipartimento PROMISE Medicina interna COVID, AOU Policlinico “P. Giaccone” Via delle Cliniche, 2
Palermo
90127
Italy

Trial participating centre

Università di Palermo
Dipartimento PROMISE Malattie Infettive, AOU Policlinico “P. Giaccone” Via delle Cliniche, 2
Palermo
90127
Italy

Trial participating centre

Università di Palermo
Dipartimento PROMISE Pneumologia COVID, AOU Policlinico “P. Giaccone” Via delle Cliniche, 2
Palermo
90127
Italy

Trial participating centre

ARNAS Civico di Cristina Benfratelli
Pneumologia COVID P.zza Nicola Leotta, 4
Palermo
90127
Italy

Trial participating centre

Ospedale Madonna dell'Alto
Medicina Interna COVID Contrada Sant Elia
Petralia Sottana (PA)
90027
Italy

Sponsor information

Organisation

University of Palermo

Sponsor details

Dipartimento PROMISE
Piazza delle Cliniche
2
Palermo
90127
Italy
+39 91 6552250
dipartimento.promise@unipa.it

Sponsor type

University/education

Website

https://www.unipa.it/dipartimenti/promise

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data will become available soon after the first publication and for 5 years for public authorities and researchers who request it, explaining the reasons and uses that will be made of it, meaning that they cannot be used to be published unless otherwise authorized)

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

NHW 31/12/2020: Uploaded protocol (not peer reviewed) Version n/a, 04 December 2020. 30/12/2020: Trial’s existence confirmed by AOU Policlinico "P. Giaccone"