Covid19COVIDADOMEVANCT04380662
Risk Factors Worsening COVID19 for Out-patient With Home Monitoring
An observational study of Covid19, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Risk factors
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble University Hospital
Grenoble, 38000
Olivier EPAULARD, MD-PhD, +33(0)476765291, OEpaulard@chu-grenoble.fr
Guillaume DEBATY, MD-PhD
About this study
Official 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.
Read more
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).
Read the 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
- Being tested
- Risk factors
- Keywords
- RISK FACTOR, HEALTH STATUS, CLINICAL CARE PATHWAY, COVID19, COHORT, OUT PATIENT
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factorsOther
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…)
| Study group | Role | What they receive |
|---|---|---|
| COVID+ patients WITH worsening of the disease | COVID+ patients WITH worsening of the disease (case group) Receives: Other: Risk factors | |
| COVID+ patients WITHOUT worsening of the disease | COVID+ patients WITHOUT worsening of the disease (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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…)
Measured: 30 days
Secondary outcomes (3)
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)
Measured: 30 days
Describe the health status at Day 30
Health status patient (stay at home, hospitalization or death)
Measured: 30 days
Describe the quality of life during the disease
EQ5D-5L score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier EPAULARD, MD-PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380662
- Sponsor's protocol ID
- 38RC20.135
- Other IDs
- 2020-A01040-39
- Acronym
- COVIDADOMEVA
- Status last verified
- Jun 2020
- First submitted
- 7 May 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32167524Fang 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.
PubMed 32171062Zhou 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.
PubMed 32171076OMS. 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
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.
PubMed 32217618
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RRisk Factors Worsening COVID19 (Coronavirus Infectious Disease 2019) for Outpatient With Home Monitoring (COVID-A-DOMEVA Study)
- ClinicalTrials.gov ID
- NCT04380662
- Acronym / sponsor ID
- COVIDADOMEVA / 38RC20.135
- Conditions
- Covid19
- Keywords
- RISK FACTOR, HEALTH STATUS, CLINICAL CARE PATHWAY, COVID19, COHORT, OUT PATIENT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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…)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID+ patients WITH worsening of the disease | – | Other: Risk factorsCOVID+ patients WITH worsening of the disease (case group) |
| COVID+ patients WITHOUT worsening of the disease | – | –COVID+ patients WITHOUT worsening of the disease (control group) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factorsThe 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…) | Other | COVID+ patients WITH worsening of the disease |
Primary outcome
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…)
3 secondary outcomes
Describe the clinical care pathway of patients from Day 0 to Day 14
Time frame: 30 days
Describe the health status at Day 30
Time frame: 30 days
Describe the quality of life during the disease
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Background: PubMed 32167524Wu 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.
- Background: PubMed 32171062Fang 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.
- Background: PubMed 32171076Zhou 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.
- BackgroundOMS. 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: PubMed 32217618Jordan 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.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier EPAULARD, MD-PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra DAVID-TCHOUDA, MD (+33(0)476767186, sdavidtchouda@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the factors associated with the worsening of the COVID19 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380662, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.