Last update : 05/05/2021 | Version : 1 | ID : 73909
General | |
Identification | |
Detailed name | Study on the implementation of the revised HOME-CoV score to guide the choice of hospitalisation or outpatient management of patients with confirmed or probable SARS-CoV-2 infection admitted to an emergency department. |
Sign or acronym | Revised HOME-CoV |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 2020-A03067-32 |
General Aspects | |
Medical area |
Emergency medicine |
Study in connection with Covid-19 |
Yes |
Health determinants |
Healthcare system and access to health care services |
Scientific investigator(s) (Contact) | |
Name of the director | Douillet |
Surname | Delphine |
Address | Departement de Médecine d'Urgence<br>4 rue Larrey<br>CHU ANGERS |
Delphine.Douillet@chu-angers.fr | |
Collaborations | |
Funding | |
Funding status |
Public |
Details | Angers University Hospital |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Angers University Hospital |
Organisation status | |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is is made on the basis of: |
Another treatment or procedure |
Database recruitment is carried out as part of an interventional study |
Yes |
Details |
Performed at group level (clusters) |
Database objective | |
Main objective |
The primary objective is to demonstrate the reliability and safety of outpatient management among patients highly suspected or confirmed as infected with COVID-19, attending an emergency department and with a revised HOME-CoV score less than 2 (negative rule).
The secondary objectives are as follows: i. Evaluate the rate of patients having required hospitalisation within 7 days following inclusion according to the revised positive or negative HOME-CoV rule. ii. Evaluate the rate of patients having required hospitalisation and initiation of oxygen therapy within 7 days following inclusion according to the revised positive or negative HOME-CoV rule. iii. Evaluate the rate of patients having required intubation within 7 days following inclusion according to the revised positive or negative HOME-CoV rule. iv. Evaluate the rate of all-cause deaths within 7 days following inclusion according to the revised positive or negative HOME-CoV rule. v. Evaluate the performance of the revised HOME-CoV score in predicting a negative outcome in the patient subgroup with SARS-CoV-2 infection confirmed by RT-PCR to rule out the risk of a negative outcome when assessed as low risk. vi. Compare the performance of the revised HOME-CoV score with that of other existing scores. |
Inclusion criteria |
Adult patient (> 18 years),
- Attending one of the emergency departments taking part in the study due to COVID-19 infection confirmed by SARS-CoV-2 positive RT-PCR, or considered highly probable by the physician managing the patient, - Not requiring management in a continuous care or intensive care unit, and subject to a decision to limit active treatment, - Having given their formal consent to take part in the study, - Registered with or a beneficiary of a social security scheme. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
Population covered |
Sick population |
Pathology | B33 - Other viral diseases, not elsewhere classified |
Gender |
Male Woman |
Geography area |
International |
Detail of the geography area | France Belgium |
Data collection | |
Dates | |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 1,300 patients |
Data | |
Database activity |
Current data collection |
Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
Clinical data (detail) |
Direct physical measures Medical registration |
Declarative data (detail) |
Face to face interview |
Procedures | |
Followed pathology | |
Promotion and access | |
Promotion | |
Access |
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