Risk Factors Worsening COVID19 for Out-patient With Home Monitoring

Study Overview
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Brief Summary
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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).

Detailed Description
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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…)

Official Title
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RRisk Factors Worsening COVID19 (Coronavirus Infectious Disease 2019) for Outpatient With Home Monitoring (COVID-A-DOMEVA Study)

Conditions
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Covid19

Intervention / Treatment
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* Other: Risk factors


Participation Criteria
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Eligibility Criteria
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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: Person deprived of liberty by judicial or administrative decision Person being subject to a legal protection measure Person who expressed opposition to participating in the COVIDADOMEVA study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID+ patients WITH worsening of the disease<br>COVID+ patients WITH worsening of the disease (case group) | Other: Risk factors<br>* 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…)<br>|
| COVID+ patients WITHOUT worsening of the disease<br>COVID+ patients WITHOUT worsening of the disease (control group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the factors associated with the worsening of the COVID19 | The event defining the aggravation will be: hospitalization (medicine, resuscitation) or death The main 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…) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the clinical care pathway of patients from Day 0 to Day 14 | Clinical and monitoring data of the the COVIDADOM cohort and of the COVIDADOMEVA case report form (CRF) | 30 days | 
| Describe the health status at Day 30 | Health status patient (stay at home, hospitalization or death) | 30 days | 
| Describe the quality of life during the disease | EQ5D-5L score | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RISK FACTOR, HEALTH STATUS, CLINICAL CARE PATHWAY, COVID19, COHORT, OUT PATIENT