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NCT Number: 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.

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).

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Key information

Conditions

SARS-CoV Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Agen-Nerac, Agen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biobank

Other
  • 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

Primary outcomes

  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.

    Time frame: Month 1

Secondary outcomes

  1. Percentage of patients hospitalized whatever the reason

    Time frame: Month 1 and 3

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

    Time frame: Month 1

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

    Time frame: Month 1

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

    Time frame: Month 1

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

    Time frame: Month 1

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

    Time frame: Day 0

  7. Virological response

    Time frame: 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 +

  8. Virological criteria linked to the emergence of resistance

    Time frame: 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

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

    Time frame: Day 0 and Month 3

  10. anti-S antibody level

    Time frame: Day 0 and Month 3

  11. Flow cytometry cartography of myeloid response

    Time frame: Day 0, 7 and Month 1

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

  12. Flow cytometry cartography of T-lymphocyte response

    Time frame: 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

  13. Flow cytometry cartography of B-lymphocyte response

    Time frame: Day 0, 7 and Month 1

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

  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

    Time frame: 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

    Time frame: 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

  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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 13, 2021
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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