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Covid-19 : 74 fiches

Tri des résultats :

ACICOVID-19 - ARRET CARDIO-RESPIRATOIRE COMPLIQUANT UNE INFECTION A CORONAVIRUS COVID-19 : étude observationnelle multicentrique d’incidence

Responsable(s) : CHELLY Jonathan

7

Mise à jour : 30/11/2020

ACICOVID-19 - ARRET CARDIO-RESPIRATOIRE COMPLIQUANT UNE INFECTION A CORONAVIRUS COVID-19 : étude observationnelle multicentrique d’incidence

Responsable(s) : CHELLY Jonathan

Objectif principal

- Evaluer l’incidence de survenue d’un arrêt cardio-respiratoire (AC) inattendu en réanimation chez les patients admis en réanimation pour une infection avérée à SARS-CoV-2

- Décrire les causes d’AC chez les patients admis en réanimation pour AC en contexte extra-hospitalier et AC en contexte intra-hospitalier ayant une infection avérée à SARS-CoV-2

Critères d'inclusion

- Hospitalisation en réanimation
- Prélèvement positif à SARS-CoV-2 quel que soit le site prélevé
- Admis en réanimation pour un arrêt cardio-respiratoire extra-hospitalier ou intra-hospitalier ou les patients déjà admis en réanimation ayant présenté un AC inattendu en réanimation
- Age > 18ans

Ré-Conf-ISS - Réunion, Confinement, Inégalités Sociales de Santé

Responsable(s) : FIANU Adrian, CIC1410

8

Mise à jour : 17/12/2020

Ré-Conf-ISS - Réunion, Confinement, Inégalités Sociales de Santé

Responsable(s) : FIANU Adrian, CIC1410

Objectif principal

Objectif principal :

Décrire, au décours du confinement mis en place pour lutter contre l’épidémie de SARS-CoV-2, l’état de santé déclaré de la population réunionnaise selon le niveau de précarité du quartier de résidence.

Objectifs secondaires :

- Décrire, au décours du confinement, l’état de santé déclaré de la population réunionnaise selon les conditions de logement pendant le confinement.

- Décrire, au décours du confinement, l’état de santé déclaré de la population réunionnaise selon les caractéristiques socio-économiques individuelles : classes d’âge et genre, statut par rapport à l’emploi et catégorie socio-professionnelle, niveau d’étude.

- Comparer le niveau de stress général déclaré dans les études régionales menées à la Réunion, pendant le confinement (étude Confin-Aou) versus au décours du confinement (étude Ré-Conf-ISS).

- Comparer l’impact psychologique du confinement entre la métropole et la Réunion à partir des résultats de l’enquête nationale Epidemic et ceux de l’enquête régionale Ré-Conf-ISS.

Critères d'inclusion

- Majeur (âge≥ 18 ans)
- Résidant sur l’île avant le 17 mars 2020
- Ayant vécu la totalité de l’épisode du confinement (entre le 17 mars et le 11 mai 2020) sur le territoire réunionnais
- Sans curatelle

BBCovid - Détection clinique du virus du SRAS-CoV-2 par voie nasale et salivaire suite à la prise de bains de bouche antiviraux.

Responsable(s) : CARROUEL Florence, Laboratoire "Parcours Santé Systémique", EA4129

9

Mise à jour : 04/01/2021

BBCovid - Détection clinique du virus du SRAS-CoV-2 par voie nasale et salivaire suite à la prise de bains de bouche antiviraux.

Responsable(s) : CARROUEL Florence, Laboratoire "Parcours Santé Systémique", EA4129

Objectif principal

Décrire l’évolution de la charge virale nasale et salivaire chez des patients probablement
infectés par le Covid-19, effectuant pendant 7 jours des bains de bouche avec et sans
antiviraux.

Critères d'inclusion

Age : 18 ans – 70 ans.
Diagnostic clinique d’infection Covid-19 par le médecin généraliste et hospitalier du patient
Début des signes cliniques depuis moins de 48 heures.
Confirmation virologique : pas nécessaire mais possible.
Compréhension et acceptation de l’essai.
Accord écrit de participation à l’essai

SOPRAC - SOins PRimaires en Auvergne-rhône-alpes pour la Covid-19

Responsable(s) : Letrilliart Laurent, HESPER

10

Mise à jour : 29/12/2020

SOPRAC - SOins PRimaires en Auvergne-rhône-alpes pour la Covid-19

Responsable(s) : Letrilliart Laurent, HESPER

Objectif principal

Estimer et de décrire l’évolution temporelle au cours de l’épidémie des indicateurs suivants dans la patientèle des structures de soins primaires en région AuRA : incidence des cas cliniquement suspects de COVID-19, incidence des cas biologiquement confirmés de COVID-19, caractéristiques cliniques de ces cas.

Critères d'inclusion

- Patient H/F
- Cas suspect ou confirmé de COVID-19 consultant dans un cabinet de médecine générale ou une maison de santé pluriprofessionnelle (MSP) de la région Auvergne-Rhône-Alpes

ONCOVID-19 - Prospective analysis of morbi-mortality of patients with cancers in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection

Responsable(s) : ASSAAD Souad

11

Mise à jour : 09/12/2020

ONCOVID-19 - Prospective analysis of morbi-mortality of patients with cancers in active phase of treatment suspected or diagnosed of a SARS-CoV-2 infection

Responsable(s) : ASSAAD Souad

Objectif principal

The primary objective is to describe the mortality of cancer patients under active anticancer treatment who underwent diagnostic procedures (positive or negative) for a suspicion of COVID-19.

The primary endpoint will be the mortality rate, defined as the proportion of patients who are dead 28 days after the date of the diagnostic procedure for the 2 cohorts of patients (positive and negative).

Critères d'inclusion

- Confirmed diagnosis of any type of solid or hematologic tumor;
- Ongoing anticancer treatment (cytotoxic, targeted therapy, immunotherapy or loco regional procedure, including radiotherapy, surgery or interventional radiology procedure) at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure) ;
- Patient with suspicion of COVID-19 (clinical symptoms of COVID-19 including fever (>38°C) and/or respiratory tract symptoms), either confirmed or not.
Note 1: Patients must have underwent diagnostic procedures: diagnostic test (positive or negative) and/or chest imaging.
Note 2: Patients will be eligible regardless of the presence of a neutropenia (either febrile or not)
- Patient and/or family did not decline data collection after complete information (information sheet)

ImmunONCOVID-20 - A prospective, controlled, randomized, multicenter study of the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) compared to the standard of care in patients with advanced or metastatic cancer and SARS-CoV-2 (COVID-19) infection.

Responsable(s) : AVRILLON Virginie

12

Mise à jour : 15/12/2020

ImmunONCOVID-20 - A prospective, controlled, randomized, multicenter study of the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) compared to the standard of care in patients with advanced or metastatic cancer and SARS-CoV-2 (COVID-19) infection.

Responsable(s) : AVRILLON Virginie

Objectif principal

The main objective is to compare versus standard of care short-term mortality rates in advanced or metastatic cancer patients who are positive for COVID-19 treated with an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) or an anti-C5aR (avdoralimab).
The primary endpoint will be the 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization.
The 28-day survival rate will be described in each arm of each cohort.

Critères d'inclusion

Inclusion criteria
I1. Age 18 or older at the time of enrolment for women and age 60 or older at the time of enrolment for men.
I2. Histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization).
I3. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) without indication of transfer in a rescucitation unit. .
Nota Bene : A maximum time of 7 days may have elapsed between the date of first symptoms and the date of consent for patient cohort 1 (mild). In cohort 2 (severe), up to 10 days may have elapsed since the first symptoms.
I4. Cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg.
I5. Multidisciplinary approach that patient is not eligible for a transfer to Resuscitation Unit (either due to underlying medical condition – including cancer – or due to lack of available bed).
Note: Item cancelled (addendum 2 – October 2020)
I6. Life-expectancy longer than 3 months.
I7. Adequate bone marrow and end-organ function defined by the following laboratory results:
• Bone marrow:
- Hemoglobin ≥ 9.0 g/dL,
- Absolute Neutrophils Count (ANC) ≥ 1.0 Gi/L,
- Platelets ≥ 100 Gi/L;
• Hepatic function:
- Total serum bilirubin ≤ 1.5 x ULN (except patients with Gilbert’s syndrome who must have total serum bilirubin ≤ 3.0 x ULN),
- AST and ALT ≤ 5 ULN
• Renal function:
- Serum creatinine ≤ 2.0 x ULN or Cr. Cl. ≥ 30ml/min/1.73m² (MDRD or CKD-EPI formula);
I8. Willingness and ability to comply with the study requirements;
I9. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrollment (in case of emergency situation, please refer to protocol section 12.1 PATIENT INFORMATION AND INFORMED CONSENT);
I10. Women of childbearing potential (Appendix 1) are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test;
I11. Women of childbearing potential and male patients must agree to use adequate highly effective contraception (Appendix 1) for the duration of study participation and up to 6 months following completion of therapy;
I12. Patient must be covered by a medical insurance.

Non-inclusion criteria
E1. For cohort 1 only : Patient currently receiving therapy with an anti-NKG2A.
E2. For cohort 2 only: Patient currently receiving therapy with an anti-C5aR.
E3. Contraindication to treatment with monalizumab (cohort 1 only) or avdoralimab (cohort 2 only) as per respective IB, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody.
E4. For cohort 1 only : Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). Patients previously exposed to CQ, HCQ or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization.
E5. Patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents.
a. Note 1: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjögren’s syndrome will not be excluded from the study.
b. Note 2: Patients may receive corticosteroids as required for the management of SARS-CoV-2-related symptoms.
E6. Patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to :
 Major surgery.
 Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.
E7. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, Known Left Ventricular Ejection Fraction (LVEF) < 50%.
a. Note: Patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate.
E8. Patient has known active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening), known active hepatitis C (Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening) or known Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
E9. Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
E10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
E11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
E12. Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

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