Risk Factors Worsening COVID19 for Out-patient With Home Monitoring

NCT04380662 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2020-06-22

No results posted yet for this study

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

Interventions

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…)

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Olivier EPAULARD, MD-PhD · University Hospital, Grenoble

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-09-30
Completion
2020-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380662 on ClinicalTrials.gov