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

NCT04437719 | Completed

• 1 other identifier: OBVIONCO
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence and course of symptoms of COVID-19 infection

  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

Study Arms (1)

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.

Other: Obvio-19 app

Interventions

Obvio-19 app OTHER

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.

Obvio-19 App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• ObvioHealth: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related 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;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 RESULT

• 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/

  PMID: 29708678 RESULT

Related Links

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

MeSH Terms

Conditions

Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric Raymond, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 18, 2020
• Study Start: June 29, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 3, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

FR (1)