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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437719
• Other study ID #: OBVIONCO
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: June 3, 2022

Study information

• Verified date: June 2022
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 3, 2022
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Neoplasms
• Oncology

Intervention

Other:
• Obvio-19 app
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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	ObvioHealth

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Observational period of 6 months
Secondary	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.	During a period of 6 months
Secondary	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.	After a period of 6 months

External Links

•   Features, Evaluation and Treatment Coronavirus (COVID-19) Marco Cascella; Michael Rajnik; Arturo Cuomo; Scott C. Dulebohn; Raffaela Di Napoli.