Clinical trial NCT04885452: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid19
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2021-05-13
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected with SARS-CoV-2 referred by their doctor (general practitioner, specialist, SOS doctor, etc.) to a prescribing center authorized to prescribe and deliver treatments benefiting from an ATU/AAP.

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).


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

Primary outcomes:
measure: 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.
timeFrame: Month 1
Secondary outcomes:
measure: Percentage of patients hospitalized whatever the reason
timeFrame: Month 1 and 3
measure: Percentage of patients with an WHO score >= 5
timeFrame: Month 1
measure: Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset
timeFrame: Month 1
measure: Percentage of patients who died from COVID-19 complications and any other reason
timeFrame: Month 1
measure: Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events
timeFrame: Month 1
measure: Time between first symptoms and treatment and the reasons for this delay
timeFrame: Day 0
measure: Virological response
timeFrame: Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients
measure: Virological criteria linked to the emergence of resistance
timeFrame: from inclusion until a negative PCR test or Ct ≥31 is obtained
measure: Percentage of patients with positive anti-N and anti-S serology
timeFrame: Day 0 and Month 3
measure: anti-S antibody level
timeFrame: Day 0 and Month 3
measure: Flow cytometry cartography of myeloid response
timeFrame: Day 0, 7 and Month 1
measure: Flow cytometry cartography of T-lymphocyte response
timeFrame: Day 0, 7 and Month 1
measure: Flow cytometry cartography of B-lymphocyte response
timeFrame: Day 0, 7 and Month 1
measure: 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
timeFrame: Day 0, 7 and Month 1
measure: Clinical and biological predictors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants) of the onset of complications from COVID19, hospitalization, death
timeFrame: from inclusion until the end of the follow-up (Month 1 or Month 3)
measure: 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
timeFrame: from inclusion until the end of the follow-up (Month 1 or Month 3)
measure: Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains)
timeFrame: from inclusion until the end of the follow-up (Month 1 or Month 3)
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen-Nerac
city: Angers
country: France
facility: CHU d'Angers
city: Ars-Laquenexy
country: France
facility: CHR Metz-Thionville
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien - Hématologie
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien - Néphrologie
city: Dijon
country: France
facility: CHU de Dijon
city: Fort-de-France
country: France
facility: CHU de Martinique
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - Médecine interne
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - SMIT
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon (HCL)
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: Hôpital Lariboisière - SMIT
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Hôpital Bichat Claude-Bernard
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Bichat Claude-Bernard - SAU
city: Paris
country: France
facility: Hôpital Lariboisière - SAU SMUR
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Saint Antoine - SAU
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Paris
country: France
facility: Hôpitaux Cochin - Port Royal
city: Poissy
country: France
facility: CHI Poissy St Germain en Laye
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: Tarbes
country: France
facility: CH de Tarbes
city: Toulouse
country: France
facility: CHU de Toulouse - IUCT - Oncopole
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
Study officials:
affiliation: Saint Antoine Hospital
name: Youri Yordanov, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruel T, Vrignaud LL, Porrot F, Staropoli I, Planas D, Guivel-Benhassine F, Puech J, Prot M, Munier S, Henry-Bolland W, Soulie C, Zafilaza K, Lusivika-Nzinga C, Meledge ML, Dorival C, Molino D, Pere H, Yordanov Y, Simon-Loriere E, Veyer D, Carrat F, Schwartz O, Marcelin AG, Martin-Blondel G; ANRS 0003S CoCoPrev Study Group. Antiviral activities of sotrovimab against BQ.1.1 and XBB.1.5 in sera of treated patients. medRxiv [Preprint]. 2023 May 30:2023.05.25.23290512. doi: 10.1101/2023.05.25.23290512.
citation: Bruel T, Vrignaud LL, Porrot F, Staropoli I, Planas D, Guivel-Benhassine F, Puech J, Prot M, Munier S, Bolland WH, Soulie C, Zafilaza K, Lusivika-Nzinga C, Meledge ML, Dorival C, Molino D, Pere H, Yordanov Y, Simon-Loriere E, Veyer D, Carrat F, Schwartz O, Marcelin AG, Martin-Blondel G; ANRS 0003S CoCoPrev Study Group. Sotrovimab therapy elicits antiviral activities against Omicron BQ.1.1 and XBB.1.5 in sera of immunocompromised patients. Med. 2023 Oct 13;4(10):664-667. doi: 10.1016/j.medj.2023.07.007.
citation: Martin-Blondel G, Marcelin AG, Soulie C, Kaisaridi S, Lusivika-Nzinga C, Zafilaza K, Dorival C, Nailler L, Boston A, Ronchetti AM, Melenotte C, Cabie A, Choquet C, Trinh-Duc A, Lacombe K, Gaube G, Coustilleres F, Pourcher V, Martellosio JP, Peiffer-Smadja N, Chauveau M, Housset P, Piroth L, Devaux M, Pialoux G, Martin A, Dubee V, Frey J, Le Bot A, Cazanave C, Petua P, Liblau R, Carrat F, Yordanov Y. Time to negative PCR conversion amongst high-risk patients with mild-to-moderate Omicron BA.1 and BA.2 COVID-19 treated with sotrovimab or nirmatrelvir. Clin Microbiol Infect. 2023 Apr;29(4):543.e5-543.e9. doi: 10.1016/j.cmi.2022.12.016. Epub 2022 Dec 28.
citation: Martin-Blondel G, Marcelin AG, Soulie C, Kaisaridi S, Lusivika-Nzinga C, Dorival C, Nailler L, Boston A, Melenotte C, Gaube G, Choquet C, Liblau R, Carrat F, Yordanov Y; COCOPREV Study Group. Outcome of very high-risk patients treated by Sotrovimab for mild-to-moderate COVID-19 Omicron, a prospective cohort study (the ANRS 0003S COCOPREV study). J Infect. 2022 Jun;84(6):e101-e104. doi: 10.1016/j.jinf.2022.04.010. Epub 2022 Apr 7. No abstract available.