Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Factors Worsening COVID19 for Out-patient With Home Monitoring (COVIDADOMEVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380662
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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).


Condition or disease Intervention/treatment
Covid19 Other: Risk factors

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…)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RRisk Factors Worsening COVID19 (Coronavirus Infectious Disease 2019) for Outpatient With Home Monitoring (COVID-A-DOMEVA Study)
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 30, 2020

Group/Cohort Intervention/treatment
COVID+ patients WITH worsening of the disease
COVID+ patients WITH worsening of the disease (case group)
Other: 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…)

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



Primary Outcome Measures :
  1. Identify the factors associated with the worsening of the COVID19 [ Time Frame: 30 days ]

    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…)


Secondary Outcome Measures :
  1. Describe the clinical care pathway of patients from Day 0 to Day 14 [ Time Frame: 30 days ]
    Clinical and monitoring data of the the COVIDADOM cohort and of the COVIDADOMEVA case report form (CRF)

  2. Describe the health status at Day 30 [ Time Frame: 30 days ]
    Health status patient (stay at home, hospitalization or death)

  3. Describe the quality of life during the disease [ Time Frame: 30 days ]
    EQ5D-5L score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380662


Contacts
Layout table for location contacts
Contact: Sandra DAVID-TCHOUDA, MD +33(0)476767186 sdavidtchouda@chu-grenoble.fr
Contact: Sandrine MASSICOT, Master +33(0)476768860 smassicot@chu-grenoble.fr

Locations
Layout table for location information
France
Grenoble University Hospital
Grenoble, France, 38000
Contact: Olivier EPAULARD, MD-PhD    +33(0)476765291    OEpaulard@chu-grenoble.fr   
Sub-Investigator: Guillaume DEBATY, MD-PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Olivier EPAULARD, MD-PhD University Hospital, Grenoble
Publications:
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

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04380662    
Other Study ID Numbers: 38RC20.135
2020-A01040-39 ( Other Identifier: ID RCB )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
RISK FACTOR
HEALTH STATUS
CLINICAL CARE PATHWAY
COVID19
COHORT
OUT PATIENT