Prevention of COVID-19 Complications in High-risk Subjects Infected by SARS-CoV-2 and Eligible for Treatment Under a Cohort ATU ('Autorisation Temporaire d'Utilisation') OR or Authorisation for Early Access (AAP). A Prospectvie Cohort.

Completed

• Conditions: SARS-CoV Infection; Covid19

• Registration Number: NCT04885452
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

This is a prospective, multicentric, non comparative study aiming to evaluate the clinical and virological evolution of high-risk patients infected with SARS-CoV-2 treated withtin the framework of a cohort ATU ('Autorisation temporaire d'utilisation') or authorisation for early access (AAP) delivered by the French drug agency (ANSM).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-13
• Study Start: 2021-09-21
• Primary Completion: 2023-06-18
• Study Completion: 2023-12-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

• Adults with the criteria for COVID-19 treatment within the French compassionate program (ATU/AAP)
• Adults covered by the French social health coverage
• Adults who signed the informed consent form

Exclusion Criteria

• Exclusion criteria described in the French compassionate program (ATU/AAP)
• Patient participating in another biomedical research with an exclusion period ongoing at inclusion
• Vulnerable patient (adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty)
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients hospitalized (if the patient was outpatient) or whose hospitalization was extended for complications from COVID-19 within 1 month of symtoms' onset.	Month 1

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who died from COVID-19 complications and any other reason	Month 1
Virological response	Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients	Percentage of virological response defined by CT\>=31 or negative PCR test +
anti-S antibody level	Day 0 and Month 3
Percentage of patients hospitalized whatever the reason	Month 1 and 3
Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset	Month 1
Virological criteria linked to the emergence of resistance	from inclusion until a negative PCR test or Ct ≥31 is obtained	Percentage of patients included developing resistance variants, genotypic and phenotypic characterization of resistance variants
Percentage of patients with an WHO score >= 5	Month 1
Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events	Month 1
Flow cytometry cartography of myeloid response	Day 0, 7 and Month 1	Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response
Clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response	from inclusion until the end of the follow-up (Month 1 or Month 3)	Identification of clinical and biological predictive factors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants)) linked to the neutralizing serological response: non-response, duration of the response by a logistic model or mixed model for repeated measures
Time between first symptoms and treatment and the reasons for this delay	Day 0
Percentage of patients with positive anti-N and anti-S serology	Day 0 and Month 3
Dosing of a wide range of cytokines and chemokines (IFNalpha, IFNgamma, IL-6, IL-1, IL-8, IL-15, IL-18, IL1-RA, IL-7, IL-10, CXCL10, CXCL13, CCL2 and CCL3) using the Meso Scale Discovery approach	Day 0, 7 and Month 1
Flow cytometry cartography of T-lymphocyte response	Day 0, 7 and Month 1	Flow cytometry cartography of T-lymphocyte (conventional T-lymphocytes by identifying naïve, memory and effector Th1, Th2, Tfh and Th17 T-lymphocytes, NK and gamma-delta T-lymphocytes, regulatory T-lymphocytes; surface and intracellular markers) response
Flow cytometry cartography of B-lymphocyte response	Day 0, 7 and Month 1	Flow cytometry cartography of B-lymphocyte (transitional, naïve, memory T-lymphocyte with or without isotypic switching, plasmablasts) response
Clinical and biological predictors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants) of the onset of complications from COVID19, hospitalization, death	from inclusion until the end of the follow-up (Month 1 or Month 3)	Identication of clinical and biological predictors of the onset of complications from COVID19, hospitalization, death by a logistic model or survival model (RMST): the response variable is the occurrence of a complication, hospitalization, death or the average survival at 1 month on these different criteria; the covariates are the parameters at inclusion, the treatment received, the virological criteria (CT, variants) which can be considered as a time-dependent covariate
Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains)	from inclusion until the end of the follow-up (Month 1 or Month 3)	Identification of clinical and biological predictive factors related to the virological response (viral genotypes, emergence of resistant strains) by a logistic model: the response variable is RT-PCR negativation at D7 (or CT≥31), the covariates are the parameters at inclusion, the treatment received, the virological criteria at baseline

Trial Locations

Locations (37)

CH Agen-Nerac; 🇫🇷 Agen, France

CHU d'Angers; 🇫🇷 Angers, France

CHR Metz-Thionville; 🇫🇷 Ars-Laquenexy, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Sud Francilien - Hématologie; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Sud Francilien - Néphrologie; 🇫🇷 Corbeil-Essonnes, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Martinique; 🇫🇷 Fort-de-France, France

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