Risk Factors Worsening COVID19 for Out-patient With Home Monitoring

NCT04380662 | Unknown

• 2 other identifiers: 38RC20.1352020-A01040-39
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Covid19

Keywords

RISK FACTOR; HEALTH STATUS; CLINICAL CARE PATHWAY; COVID19; COHORT; OUT PATIENT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Describe the clinical care pathway of patients from Day 0 to Day 14

  30 days

• Describe the health status at Day 30

  30 days

• Describe the quality of life during the disease

  30 days

Study Arms (2)

COVID+ patients WITH worsening of the disease

COVID+ patients WITH worsening of the disease (case group)

Other: Risk factors

COVID+ patients WITHOUT worsening of the disease

COVID+ patients WITHOUT worsening of the disease (control group)

Interventions

Risk factors OTHER

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…)

COVID+ patients WITH worsening of the disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, 38000, France

Location

Related Publications (5)

• 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.

  PMID: 32167524 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.

  PMID: 32171062 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.

  PMID: 32171076 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

  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.

  PMID: 32217618 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Olivier EPAULARD, MD-PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra DAVID-TCHOUDA, MD

CONTACT

+33(0)476767186; sdavidtchouda@chu-grenoble.fr

Sandrine MASSICOT, Master

CONTACT

+33(0)476768860; smassicot@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: June 30, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)