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SARS-CoV InfectionNCT04885452

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.

An observational study of SARS-CoV Infection and Covid19, run by ANRS, Emerging Infectious Diseases at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV Infection, Covid19
What is being tested?
biobank
How many people
756 participants
Where
37 sitesFrance
Study dates
21 Sep 2021to 18 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CH Agen-Nerac

    Agen

  • CHU d'Angers

    Angers

  • CHR Metz-Thionville

    Ars-Laquenexy

  • Hôpital Avicenne

    Bobigny

  • CHU de Bordeaux

    Bordeaux, 33076

  • CHU Gabriel Montpied

    Clermont-Ferrand

  • Centre Hospitalier Sud Francilien - Hématologie

    Corbeil-Essonnes, 91106

  • Centre Hospitalier Sud Francilien - Néphrologie

    Corbeil-Essonnes, 91106

  • CHU de Dijon

    Dijon

  • CHU de Martinique

    Fort-de-France, 97261

  • Hôpital Bicêtre - Médecine interne

    Le Kremlin-Bicêtre, 94275

  • Hôpital Bicêtre - SMIT

    Le Kremlin-Bicêtre, 94275

  • CHU de Limoges

    Limoges

  • Hospices Civils de Lyon (HCL)

    Lyon

  • CHU de Montpellier

    Montpellier

  • CHRU de Nancy

    Nancy, 54511

  • CHU de Nantes

    Nantes

  • CHU de Nîmes

    Nîmes

  • Hôpital Lariboisière - SMIT

    Paris, 75010

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital Bichat Claude-Bernard

    Paris, 75018

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Bichat Claude-Bernard - SAU

    Paris

  • Hôpital Lariboisière - SAU SMUR

    Paris

  • Hôpital Pitié-Salpêtrière

    Paris

  • Hôpital Saint Antoine - SAU

    Paris

  • Hôpital Saint-Louis

    Paris

  • Hôpital Universitaire Necker Enfants Malades

    Paris

  • Hôpitaux Cochin - Port Royal

    Paris

  • CHI Poissy St Germain en Laye

    Poissy

  • CHU de Poitiers

    Poitiers

  • CHU de Rennes

    Rennes

  • CH de Tarbes

    Tarbes

  • CHU de Toulouse - IUCT - Oncopole

    Toulouse

  • CHU de Toulouse

    Toulouse

  • CH de Tourcoing

    Tourcoing

  • CHRU de Tours - Hôpital Bretonneau

    Tours

Other trials in France

About this study

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.

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).

Being tested
biobank
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biobankOther

    • Blood samples (biobank) at Day 0, Day 7, Month 1 and possibly Month 3 (only for the first 100 participants) (serum, plasma and whole blood)
    • For participants in the immunological ancillary study: additional blood sampling at Day 0, Day 7 and Month 1 (PBMC)
    • Nasopharyngeal swabs: Day 0, Day 7 (Day 14 and Day 21 if RT-PCR positive respectively at Day 7 and Day 14)
    • Specific nasopharyngeal swabs in hospitalized patients: Day 3, Day 5
Study groups in NCT04885452
Study groupRoleWhat they receive
Patients treated with casirivimab/imdevimab according to the ATU protocolNot described
Receives: Other: biobank
Patients treated with bamlanivimab/etesevimab according to the ATU protocolNot described
Receives: Other: biobank
Patients treated with Xevudy according to the authorisation for early access (AAP) protocolNot described
Receives: Other: biobank
Patients treated with Paxlovid according to the authorisation for early access (AAP) protocolNot described
Receives: Other: biobank

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 1

Secondary outcomes (17)

  1. Percentage of patients hospitalized whatever the reason

    Measured: Month 1 and 3

  2. Percentage of patients with an WHO score >= 5

    Measured: Month 1

  3. Percentage of patients staying in an Intensive Care Unit in the month following symptoms' onset

    Measured: Month 1

  4. Percentage of patients who died from COVID-19 complications and any other reason

    Measured: Month 1

  5. Percentage of patients presenting a adverse event and percentage of treatment discontinuation caused by those adverse events

    Measured: Month 1

  6. Time between first symptoms and treatment and the reasons for this delay

    Measured: Day 0

  7. Virological response

    Percentage of virological response defined by CT>=31 or negative PCR test +

    Measured: Day 7 for ambulatory patients, Day 3, 5 and 7 for hospitalized patients

  8. Virological criteria linked to the emergence of resistance

    Percentage of patients included developing resistance variants, genotypic and phenotypic characterization of resistance variants

    Measured: from inclusion until a negative PCR test or Ct ≥31 is obtained

  9. Percentage of patients with positive anti-N and anti-S serology

    Measured: Day 0 and Month 3

  10. anti-S antibody level

    Measured: Day 0 and Month 3

  11. Flow cytometry cartography of myeloid response

    Flow cytometry cartography of myeloid (functional subtypes of monocytes and dendritic cells) response

    Measured: Day 0, 7 and Month 1

  12. Flow cytometry cartography of T-lymphocyte response

    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

    Measured: Day 0, 7 and Month 1

  13. Flow cytometry cartography of B-lymphocyte response

    Flow cytometry cartography of B-lymphocyte (transitional, naïve, memory T-lymphocyte with or without isotypic switching, plasmablasts) response

    Measured: Day 0, 7 and Month 1

  14. 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

    Measured: Day 0, 7 and Month 1

  15. Clinical and biological predictors (clinical parameters, treatment received, virological criteria (cycle threshold (CT), variants) of the onset of complications from COVID19, hospitalization, death

    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

    Measured: from inclusion until the end of the follow-up (Month 1 or Month 3)

  16. 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

    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

    Measured: from inclusion until the end of the follow-up (Month 1 or Month 3)

  17. Clinical and biological predictors (clinical parameters, treatment received, virological criteria) of viral response (viral genotypes, emergence of resistant strains)

    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

    Measured: from inclusion until the end of the follow-up (Month 1 or Month 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start21 Sep 2021
  3. Primary completion18 Jun 2023
  4. Study completion18 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885452
Sponsor's protocol ID
ANRS0003S COCOPREV
Status last verified
May 2025
First submitted
5 May 2021
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37398037

  • 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.

    PubMed 37837962

  • 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.

    PubMed 36586513

  • 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.

    PubMed 35398409

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV Infection and Covid19, run by ANRS, Emerging Infectious Diseases at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Month 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885452, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.

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