ITMO public health
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 |
| Keywords | COVID-19; Hospitalization; Outpatient; Rule validation; Expert consensus; Rule-based decision-making; Clinical support decision tool. |
| 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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