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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01040-39 | Other Identifier | ID RCB |
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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:
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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID+ patients WITH worsening of the disease | COVID+ patients WITH worsening of the disease (case group) |
| |
| COVID+ patients WITHOUT worsening of the disease | COVID+ patients WITHOUT worsening of the disease (control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk factors | Other | The studied potential risk factors will be the following:
|
| 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:
| 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The patients included in the study are from the Grenoble area, had contacted the accident and emergency ward (A&E department) or their general practitioner (GP). The patients recruited are patients suspected of being infected with SARS-CoV-2, with home monitoring including the containment measures set up according to the French Health recommendations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra DAVID-TCHOUDA, MD | Contact | +33(0)476767186 | sdavidtchouda@chu-grenoble.fr | |
| Sandrine MASSICOT, Master | Contact | +33(0)476768860 | smassicot@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier EPAULARD, MD-PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble University Hospital | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32167524 | Background | Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. | |
| 32171062 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012307 | Risk Factors |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
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|
Health status patient (stay at home, hospitalization or death)
| 30 days |
| Describe the quality of life during the disease | EQ5D-5L score | 30 days |
| Background |
| Fang L, Karakiulakis G, Roth M. Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? Lancet Respir Med. 2020 Apr;8(4):e21. doi: 10.1016/S2213-2600(20)30116-8. Epub 2020 Mar 11. No abstract available. |
| 32171076 | Background | Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. |
| Background | OMS. Soins à domicile pour les patients COVID-19 qui présentent des symptômes bénins, et prise en charge de leurs contacts. Lignes directrices provisoires, 17 mars 2020 (5pages). WHO reference number : WHO/2019-nCoV/IPC/HomeCare/2020.3 |
| 32217618 | Background | Jordan RE, Adab P, Cheng KK. Covid-19: risk factors for severe disease and death. BMJ. 2020 Mar 26;368:m1198. doi: 10.1136/bmj.m1198. No abstract available. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 |
| Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |