Risk Factors Worsening COVID19 for Out-patient With Home Monitoring (COVIDADOMEVA)

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Covid19

Treatments

Other: Risk factors

Study type

Observational

Funder types

Other

Identifiers

NCT04380662

2020-A01040-39 (Other Identifier)

38RC20.135

Details and patient eligibility

About

The main objective of the COVIDADOMEVA study is to identify the risk factors aggravating the COVID-19 (risk or protective factors), in out-patients suspected of being infected with precocious home monitoring.

The primary event defining the aggravation will be then: hospitalization (medicine, resuscitation) or death.

The studied potential risk factors will be mainly:

Socio-demographic: age, sex, place of residence or income
Comorbidities
Clinical signs: asthenia, dyspnea (kinetics)...
Drugs other than those related to the infection

For this research project, this study needs to use the patient's data of the COVIDADOM cohort (patients suspected of being infected with SARS-CoV-2 with home monitoring) and will collect some supplementary data (clinical and biological). All these data will be integrated and analyzed in the PREDIMED clinical data lake platform (The implementation of PREDIMED has been approved by the French authority in terms of GDPR, CNIL, on October 10, 2019).

Full description

In front of the recent emergence of the SARS-CoV-2 coronavirus (COVID) in December 2019 in the Wuhan region of China, knowledge of the clinical course and of the aggravating risk factors linked to this virus is still incomplete.

COVID is associated with severe morbidity and an estimated mortality of 2-4% in patients without comorbidity. According to a WHO report published on the situation in China, patients with serious chronic pathologies, such as diabetes or severe obesity, are particularly vulnerable and mortality rates were higher: from 7 to 13%.

Monitoring and describing the clinical pathway of out-patients suspected of being infected according to their medical history should improve knowledge of COVID, and then adapt patient care management and control the COVID pandemic.

Currently, few European studies have described the potential risk factors that could lead to the worsening of the disease. Since the March 16th, the university hospital of Grenoble (France) has developed an information technology system to monitor out-patients suspected of being infected with SARS-CoV-2 coronavirus and with early home monitoring: the COVIDADOM cohort

That's why the COVIDADOMEVA study is then to identify the risk factors aggravating the COVID, in out-patients with precocious home monitoring.

The primary event defining the aggravation will be then: hospitalization (medicine, resuscitation) or death

The studied potential risk factors will be the following:

Socio-demographic: age, sex, place of residence, CSP, and income.
Comorbidities or aggravation: COPD, asthma, immunosuppression, or heart failure, diabetes imbalance, etc.
Clinical signs: asthenia, dyspnea (kinetics), blood sugar, nutritional status, weight gain...
Drugs other than those related to the infection and potential self-medication (anti-inflammatory, CEI, ARA...)

Enrollment

800 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with clinical symptomatology suspecting COVID-19, that is to say: severe dyspnea, and/or serious extra pulmonary signs (myalgia, diarrhea, etc.) OR
Patient with clinical symptomatology (cough or dyspnea or fever with ENT signs) AND at least one of the following comorbidities: COPD stage 1 or 2 (dyspnea usually absent or for marked efforts), Asthma with daily inhaled corticosteroid therapy, Immunosuppression or cancer during chemotherapy, Coronary history, Heart failure (Stages 2 and 3, dyspnea with moderate or low effort), Obesity (BMI> 30), Type 1 or 2 diabetes, cirrhosis from Child B, pregnant woman in the 3rd trimester.
Patient with a phone monitoring of at least more than 2 calls, if no aggravation of disease.

Exclusion criteria