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

Not Applicable

Completed

• Conditions: COVID-19; Oncology
• Interventions: Other: Obvio-19 app

• Registration Number: NCT04437719
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-06-29
• Primary Completion: 2021-06-28
• Status Verified: 2022-06
• Study Completion: 2022-06-03
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obvio-19 App	Obvio-19 app	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.

Primary Outcome Measures

Name	Time	Method
COVID-19 infection's symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Incidence and course of symptoms of COVID-19 infection	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.
Correlation of the COVID-19 infection with the biological and clinical data of patients	After 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.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France