Impact of COVID-19 SARS-CoV-2 Variability in ICU Hospitalized Patients With Severe Disease
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 10, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how different versions of the COVID-19 virus, known as variants, affect patients who are seriously ill and hospitalized in intensive care units (ICUs). Researchers want to find out if specific changes in the virus's genetic makeup relate to how severe a patient’s illness becomes and their overall recovery. By studying these relationships, the trial aims to gather important information that could help improve treatment and control measures for COVID-19 in the future.
To be eligible for the trial, participants must be at least 18 years old and have tested positive for COVID-19 with a specific test result. They should also be admitted to the ICU due to severe breathing difficulties. The study will take place over a total of 28 days for each participant, with a longer overall duration for the trial itself. If you or a family member are considering participating, you can expect to provide a sample from your nose and have regular observations during your hospital stay. This research could play a vital role in understanding how new variants of the virus impact health outcomes for serious COVID-19 cases.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years.
- • Availability of nasopharyngeal swab from SOC
- • SARS-CoV-2 infection as assessed by a positive RT-PCR test (CT \< 32), including in SARS CoV-2 vaccinated or previously infected patients
- • Patient admitted in the ICU for acute respiratory failure (SpO2 ≤ 90% and need for supplemental oxygen or any kind of ventilator support; i.e., OMS 10-category ordinal scale ≥5)
- • Patient or trusted person or close or relative, And, accepting study participation
- Exclusion Criteria:
- • Patient with SARS-CoV-2 infection but no acute respiratory failure
- • Patient deprived of liberty or under legal protection (guardianship, curators, legal protection, forced hospitalization)
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Créteil, Val De Marne, France
Patients applied
Trial Officials
Slim FOURATI, MD-PHD
Principal Investigator
Assistance Publique - Hôpitaux de Paris (AP-HP) Henri Mondor
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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