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 Prospective Cohort.

ANRS, Emerging Infectious Diseases37 sites in 1 country756 target enrollmentSeptember 21, 2021

ConditionsSARS-CoV Infection Covid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: SARS-CoV Infection
Sponsor: ANRS, Emerging Infectious Diseases
Enrollment: 756
Locations: 37
Primary Endpoint: 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.
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 21, 2021

End Date

December 18, 2023

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

ANRS, Emerging Infectious Diseases

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: Month 1

Secondary Outcomes

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)
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 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)
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))
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 B-lymphocyte response(Day 0, 7 and Month 1)
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))
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))