NCT04437719

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oncology
• COVID-19

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-29
• Primary completion: 2021-06-28
• Completion: 2022-06-03
• First posted: 2020-06-18
• Last updated: 2022-06-30

Locations

1 site across 1 country: France