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Covid-19 : 32 fiches

Tri des résultats :

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

Responsable(s) : Letrilliart Laurent, HESPER

7

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

8

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

9

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.

RDCOVID19 - Incidence and Characteristics of Retinal Detachment during Coronavirus-19 Pandemic

Responsable(s) : Paques Michel, Ophthalmology

10

Mise à jour : 13/12/2020

RDCOVID19 - Incidence and Characteristics of Retinal Detachment during Coronavirus-19 Pandemic

Responsable(s) : Paques Michel, Ophthalmology

Objectif principal

To assess the impact of the Covid-19 pandemic and subsequent lockdown on the number and clinical characteristics of patients with retinal detachment (RD) in a French public university eye hospital.

Critères d'inclusion

Single-center, retrospective non-interventional study. Patients consulting at the emergency room (ER) of Quinze-Vingts Hospital (France) for rhegmatogenous RD before and after instauration of the lockdown. Number of cases, delay between diagnosis and surgery, visual acuity were measured.

ONCOVID-21 - Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)

Responsable(s) : MASTROIANNI BENEDICTE, Medical Oncology Department

11

Mise à jour : 15/12/2020

ONCOVID-21 - Evaluation of a ddPCR technology for the SARS-CoV-2 detection based on different types of samples in cancer patients with suspicion of COVID-19 (symptomatic)

Responsable(s) : MASTROIANNI BENEDICTE, Medical Oncology Department

Objectif principal

To determine the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA IgG) as gold/reference standard (FDA validated commercial serologic test).
The primary endpoint will be the sensibility of the ddPCR assay for SARS-CoV-2 detection based on nasopharyngeal samples.

Critères d'inclusion

1. Age ≥ 18 years on the day of signing informed consent.
2. Confirmed diagnosis of any type of solid or hematologic tumor.
3. Ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure)
4. Suspicion of COVID-19 infection. Patients must not have underwent diagnostic test and/or chest imaging before inclusion.
* At least one of the following clinical symptoms: fever (>38°C), dry cough, fatigue, pulmonary involvement (febrile respiratory infection or respiratory difficulties), pharyngalgia, headaches, myalgia, gastrointestinal symptoms including abdominal pain and diarrhea, anosmia and agueusia, radiological signs of pneumonia as described by Shi et al.
5. Covered by a medical/health insurance.
6. Signed and dated informed consent form.

Psy-GIPO2C - Psychiatry Professionals and Covid 19 in Europe: Psychological Impact Management and Crisis and Post-Crisis Organisation

Responsable(s) : Frédéric DENIS

12

Mise à jour : 09/01/2021

Psy-GIPO2C - Psychiatry Professionals and Covid 19 in Europe: Psychological Impact Management and Crisis and Post-Crisis Organisation

Responsable(s) : Frédéric DENIS

Objectif principal

The project will provide an intelligent, European-wide perspective, to enable the sharing of innovative practices in a very operational manner.

Critères d'inclusion

Approximately 2,000 psychiatric care professionals,

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