SARS-CoV2 Infection Clinical Trial
— SEVARVIROfficial title:
Characterization of the Impact of SARS-CoV-2 Variability on the Course of COVID-19 in Patients With Severe Disease Hospitalized in Intensive Care Units: Prospective Observational Multicentric Study
Background:The impact of the emergence of SARS-CoV-2 variants on the severity and clinical outcomes of COVID-19 is controversial. Whether virological characteristics including the mutational patterns of the different viral proteins (e.g., Spike, NSP proteins, ORF6) could be associated with a different immune response and subsequent severity of the disease is unknown. ln the next coming months, new variants carrying the same or new mutational patterns will continue to emerge. Monitoring their dynamics over time and their impact on disease severity is required for refining national and international disease control policies. Main objective: To unravel the relationships between specific viral mutations/mutational patterns and the clinical outcomes of COVID-19 in patients hospitalized in intensive care units (ICUs) for acute respiratory failure following severe SARS-CoV-2 infection. Design of the study Prospective multicentre observational cohort study Schedule for the study: Inclusion period: 24 months; Participation period: 28 days ; Total duration : 24 months + 28 days;
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | January 16, 2026 |
Est. primary completion date | January 16, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR | Créteil | Val De Marne |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Day-28 vital status | vital status (living / deceased) | at Day-28 after admission in intensive care units (ICUs) for acute respiratory failure following severe SARS-CoV-2 infection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Recruiting |
NCT05311410 -
Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures
|
N/A | |
Active, not recruiting |
NCT05073718 -
SARS-CoV-2 and Acetylsalicylic Acid (SARA)
|
Phase 3 | |
Completed |
NCT05055505 -
The School SPIT Study - Elementary Schools in Low COVID-19 Incidence Regions
|
N/A | |
Completed |
NCT05055492 -
The School SPIT Study - Elementary Schools in High COVID-19 Incidence Regions
|
N/A | |
Completed |
NCT05060510 -
The School SPIT Study - COVID-19 Testing in Secondary Schools
|
N/A | |
Completed |
NCT05054218 -
COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients
|
||
Completed |
NCT05449392 -
Topical Antibacterial Agents for Prevention of COVID-19
|
Phase 1 | |
Completed |
NCT05076253 -
Efficacy of Ivermectin in COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT05172024 -
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
|
||
Terminated |
NCT05593770 -
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
|
Phase 2/Phase 3 | |
Completed |
NCT05030974 -
RECOVAC Repeated Vaccination Study
|
Phase 4 | |
Withdrawn |
NCT05067946 -
Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05013034 -
Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients
|
Phase 2 | |
Withdrawn |
NCT05393999 -
SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations
|
Phase 2 | |
Recruiting |
NCT05047783 -
Masitinib in Patients With Symptomatic Mild to Moderate COVID-19
|
Phase 2 | |
Not yet recruiting |
NCT05116657 -
Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
|
||
Recruiting |
NCT04590222 -
Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19
|
||
Completed |
NCT04551911 -
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
|
Phase 2 | |
Completed |
NCT04953039 -
Use of Saliva for COVID-19 Diagnosis
|