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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 (OBVIONCO)

Primary Purpose

Oncology, COVID-19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Obvio-19 app
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients unable or unwilling to perform all requested study tasks
  • Patient under tutorship or curatorship
  • Patient deprived of liberty
  • Pregnant or lactating patient

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obvio-19 App

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 17, 2020
Last Updated
June 29, 2022
Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
ObvioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT04437719
Brief Title
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
Acronym
OBVIONCO
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
Collaborators
ObvioHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obvio-19 App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Obvio-19 app
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19 infection's symptoms
Description
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.
Time Frame
Observational period of 6 months
Secondary Outcome Measure Information:
Title
Incidence and course of symptoms of COVID-19 infection
Description
To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
Time Frame
During a period of 6 months
Title
Correlation of the COVID-19 infection with the biological and clinical data of patients
Description
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.
Time Frame
After a period of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients unable or unwilling to perform all requested study tasks Patient under tutorship or curatorship Patient deprived of liberty Pregnant or lactating patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Raymond, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32007143
Citation
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.
Results Reference
result
PubMed Identifier
29708678
Citation
Gliklich 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/
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/books/NBK554776/
Description
Features, Evaluation and Treatment Coronavirus (COVID-19) Marco Cascella; Michael Rajnik; Arturo Cuomo; Scott C. Dulebohn; Raffaela Di Napoli.

Learn more about this trial

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

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