Risk Factors Worsening COVID19 for Out-patient With Home Monitoring

NCT ID: NCT04380662

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2020-12-30

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).

Detailed 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…)

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID+ patients WITH worsening of the disease

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

Risk factors

Intervention Type: 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 WITHOUT worsening of the disease

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

No interventions assigned to this group

Interventions

Risk factors

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…)

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier EPAULARD, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Grenoble University Hospital

Grenoble, , France

Countries

France

Central Contacts

Sandra DAVID-TCHOUDA, MD

Role: CONTACT

sdavidtchouda@chu-grenoble.fr

+33(0)476767186

Sandrine MASSICOT, Master

Role: CONTACT

smassicot@chu-grenoble.fr

+33(0)476768860

Facility Contacts

Olivier EPAULARD, MD-PhD

Role: primary

OEpaulard@chu-grenoble.fr

+33(0)476765291

References

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.

Reference Type: BACKGROUND

PMID: 32167524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32171062 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32171076 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32217618 (View on PubMed)

Other Identifiers

2020-A01040-39

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.135

Identifier Type: -

Identifier Source: org_study_id