OncologyOBVIONCONCT04437719
Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group for a Period of 6 Months During the COVID-19 Pandemic
A study testing Obvio-19 app in people with Oncology and COVID-19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Obvio-19 app
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 3 Jun 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age
- Patient followed in the medical oncology department of Paris Saint-Joseph Hospital Paris in France
- Patient Having regular access to smartphone and internet sufficient to support study demands
- French-speaking patient
- Affiliation to the social security network
- Willing and able to provide given oral, free, informed and express consent
Who cannot join
- Patients unable or unwilling to perform all requested study tasks
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Pregnant or lactating patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020
This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.
Read the detailed description
Prior to conducting any of the screening tests, the Investigator or his designee will explain the trial fully to the prospective patient and provide him with a copy of the Patient Information Leaflet/Informed Consent Form.
If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file.
The screening questionnaire will be completed. The patient's suitability for the trial will be confirmed by the inclusion/exclusion criteria .
Following completion of the Baseline Questionnaire, patients will receive the Daily Questionnaire. This is designed to assess if they have developed symptoms associated with COVID-19 infection.
If a participant responds that they are not feeling well, a series of follow-up questions will be asked regarding what symptoms they are currently experiencing.
The Daily Questionnaire will be asked of patients every day throughout the Observation Period of 6 months.
At the end of the Observation Period, all patients will complete a series of questionnaires relating to the conduct of the study and tools employed.
- Being tested
- Obvio-19 app
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obvio-19 appOther
As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Obvio-19 App | Experimental | If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file. After enrollment, patients will be sent an invitation via email to download the Obvio-19 mobile app. After downloading the Obvio-19 app, patients will receive instructions as to how they may communicate with the study investigator. Communication may occur through the chat function of the app or live telephone conversations.
Patients must log into the Obvio-19 app daily to complete the questionnaires. The Obvio-19 system is designed to identify responses that indicate the participant is at an increased risk for serious illness or exhibiting serious symptoms, such as coughing up blood. Such patients will be notified by the app of this status and prompted to seek medical attention. Receives: Other: Obvio-19 app |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 infection's symptoms
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
Measured: Observational period of 6 months
Secondary outcomes (2)
Incidence and course of symptoms of COVID-19 infection
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
Measured: During a period of 6 months
Correlation of the COVID-19 infection with the biological and clinical data of patients
To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months.
Measured: After a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start29 Jun 2020
- Primary completion28 Jun 2021
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Eric Raymond, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437719
- Sponsor's protocol ID
- OBVIONCO
- Acronym
- OBVIONCO
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Report No.: 17(18)-EHC013-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/
PubMed 29708678
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020
- ClinicalTrials.gov ID
- NCT04437719
- Acronym / sponsor ID
- OBVIONCO / OBVIONCO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- ObvioHealth
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 18 Jun 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.
This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.
Detailed description
Prior to conducting any of the screening tests, the Investigator or his designee will explain the trial fully to the prospective patient and provide him with a copy of the Patient Information Leaflet/Informed Consent Form.
If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file.
The screening questionnaire will be completed. The patient's suitability for the trial will be confirmed by the inclusion/exclusion criteria .
Following completion of the Baseline Questionnaire, patients will receive the Daily Questionnaire. This is designed to assess if they have developed symptoms associated with COVID-19 infection.
If a participant responds that they are not feeling well, a series of follow-up questions will be asked regarding what symptoms they are currently experiencing.
The Daily Questionnaire will be asked of patients every day throughout the Observation Period of 6 months.
At the end of the Observation Period, all patients will complete a series of questionnaires relating to the conduct of the study and tools employed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
| Arm | Type | Receives |
|---|---|---|
| Obvio-19 App | Experimental | Other: Obvio-19 appIf the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file. After enrollment, patients will be sent an invitation via email to download the Obvio-19 mobile app. After downloading the Obvio-19 app, patients will receive instructions as to how they may communicate with the study investigator. Communication may occur through the chat function of the app or live telephone conversations. Patients must log into the Obvio-19 app daily to complete the questionnaires. The Obvio-19 system is designed to identify responses that indicate the participant is at an increased risk for serious illness or exhibiting serious symptoms, such as coughing up blood. Such patients will be notified by the app of this status and prompted to seek medical attention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient over 18 years of age
- Patient followed in the medical oncology department of Paris Saint-Joseph Hospital Paris in France
- Patient Having regular access to smartphone and internet sufficient to support study demands
- French-speaking patient
- Affiliation to the social security network
Key exclusion criteria (4 listed)
- Patients unable or unwilling to perform all requested study tasks
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Pregnant or lactating patient
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 |
|---|---|---|
| Obvio-19 appAs part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes. Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months. To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months. To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months. | Other | Obvio-19 App |
Primary outcome
COVID-19 infection's symptoms
Time frame: Observational period of 6 months
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
2 secondary outcomes
Incidence and course of symptoms of COVID-19 infection
Time frame: During a period of 6 months
Correlation of the COVID-19 infection with the biological and clinical data of patients
Time frame: After a period of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Results publication: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Results publication: PubMed 29708678Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Report No.: 17(18)-EHC013-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/
- Features, Evaluation and Treatment Coronavirus (COVID-19) Marco Cascella; Michael Rajnik; Arturo Cuomo; Scott C. Dulebohn; Raffaela Di Napoli.Link provided by the sponsor.
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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.
Eric Raymond, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obvio-19 app in people with Oncology and COVID-19, run by Fondation Hôpital Saint-Joseph 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 infection's symptoms (time frame: Observational period of 6 months). 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 NCT04437719, which also lists 2 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 30 Jun 2022.