Covid19 Clinical Trial
— COVIDADOMEVAOfficial title:
RRisk Factors Worsening COVID19 (Coronavirus Infectious Disease 2019) for Outpatient With Home Monitoring (COVID-A-DOMEVA Study)
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).
Status | Not yet recruiting |
Enrollment | 800 |
Est. completion date | December 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Grenoble University Hospital | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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. Erratum in: Lancet Respir Med. 2020 Jun;8(6):e54. — View Citation
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. — View Citation
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
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 Mar 13. doi: 10.1001/jamainternmed.2020.0994. [Epub ahead of print] — View Citation
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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Describe the health status at Day 30 | Health status patient (stay at home, hospitalization or death) | 30 days | |
Secondary | Describe the quality of life during the disease | EQ5D-5L score | 30 days |
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