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Article ; Online: An open-label randomized, controlled trial of the effect of lopinavir and ritonavir, lopinavir and ritonavir plus interferon-β-1a, and hydroxychloroquine in hospitalized patients with COVID-19: final results.

Ader, Florence

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

2022 Volume 28, Issue 9, Page(s) 1293–1296

MeSH term(s)	Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Drug Combinations ; Drug Therapy, Combination ; Humans ; Hydroxychloroquine/therapeutic use ; Interferon beta-1a ; Lopinavir/therapeutic use ; Ritonavir/therapeutic use
Chemical Substances	Antiviral Agents ; Drug Combinations ; lopinavir-ritonavir drug combination ; Lopinavir (2494G1JF75) ; Hydroxychloroquine (4QWG6N8QKH) ; Ritonavir (O3J8G9O825) ; Interferon beta-1a (XRO4566Q4R)
Language	English
Publishing date	2022-05-07
Publishing country	England
Document type	Letter ; Randomized Controlled Trial
ZDB-ID	1328418-6
ISSN	1469-0691 ; 1470-9465 ; 1198-743X
ISSN (online)	1469-0691
ISSN	1470-9465 ; 1198-743X
DOI	10.1016/j.cmi.2022.04.016
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Article ; Online: Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.

Ader, Florence

BMJ open

2020 Volume 10, Issue 9, Page(s) e041437

Abstract: Introduction: To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for ... ...

Abstract	Introduction: To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19. Methods and analysis: DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included. Ethics and dissemination: Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals. Trial registration number: NCT04315948 Eudra-CT 2020-000936-23.
MeSH term(s)	Adult ; Humans ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/therapeutic use ; Betacoronavirus ; Coronavirus Infections/drug therapy ; Coronavirus Infections/therapy ; COVID-19 ; COVID-19 Drug Treatment ; Drug Combinations ; Drug Therapy, Combination ; Early Warning Score ; Extracorporeal Membrane Oxygenation ; Hospital Mortality ; Hospitalization ; Hydroxychloroquine/therapeutic use ; Interferon beta-1a/therapeutic use ; Length of Stay ; Lopinavir/therapeutic use ; Oxygen Inhalation Therapy ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/therapy ; Respiration, Artificial ; Ritonavir/therapeutic use ; SARS-CoV-2 ; Standard of Care ; Treatment Outcome ; Adaptive Clinical Trials as Topic ; Multicenter Studies as Topic ; Clinical Trials, Phase III as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX) ; Antiviral Agents ; Drug Combinations ; Hydroxychloroquine (4QWG6N8QKH) ; Interferon beta-1a (XRO4566Q4R) ; Lopinavir (2494G1JF75) ; lopinavir-ritonavir drug combination ; remdesivir (3QKI37EEHE) ; Ritonavir (O3J8G9O825)
Keywords	covid19
Language	English
Publishing date	2020-09-21
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-041437
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Article ; Online: Real-world effectiveness of oral antivirals for COVID-19.

Burdet, Charles / Ader, Florence

Lancet (London, England)

2022 Volume 400, Issue 10359, Page(s) 1175–1176

MeSH term(s)	Antiviral Agents/therapeutic use ; Dermatologic Agents ; Humans ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; Dermatologic Agents
Language	English
Publishing date	2022-10-10
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(22)01929-8
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Article ; Online: Medical management of covid-19, excluding intensive care.

Javaux, Clément / Ader, Florence

La Revue du praticien

2022 Volume 72, Issue 5, Page(s) 505–510

Abstract: MEDICAL MANAGEMENT OF COVID-19, EXCLUDING INTENSIVE CARE Management of Covid-19 is primarily guided by the severity of the respiratory involvement. Covid-19 is mostly asymptomatic or pauci-symptomatic allowing the ambulatory setting associated with ... ...

Title translation	Prise en charge médicale du Covid-19, hors réanimation.
Abstract	MEDICAL MANAGEMENT OF COVID-19, EXCLUDING INTENSIVE CARE Management of Covid-19 is primarily guided by the severity of the respiratory involvement. Covid-19 is mostly asymptomatic or pauci-symptomatic allowing the ambulatory setting associated with isolation measures going from 5 to 10 days depending on the circumstances. Nirmatrelvir/ritonavir (Paxlovid) is currently the oral treatment for Covid-19 in adult patients not requiring oxygen therapy and at risk of severe disease in the absence of contraindications. For hospitalized patients requiring oxygen support, corticosteroid therapy and anticoagulation are the main supportive treatments in association with measures preventing secondary cases. The antiviral approach is limited in this context, consisting in passive immunotherapy (mostly neutralizing monoclonal antibodies) or direct-acting antivirals active on the dominant variant and that have demonstrated clinical efficacy.
MeSH term(s)	Adult ; Antiviral Agents/therapeutic use ; COVID-19/therapy ; Hepatitis C, Chronic/drug therapy ; Humans ; Oxygen/therapeutic use ; SARS-CoV-2
Chemical Substances	Antiviral Agents ; Oxygen (S88TT14065)
Language	French
Publishing date	2022-07-28
Publishing country	France
Document type	Journal Article
ZDB-ID	205365-2
ISSN	2101-017X ; 0035-2640
ISSN (online)	2101-017X
ISSN	0035-2640
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Article: Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

Ader, Florence

BMJ Open

Abstract: INTRODUCTION: To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for ... ...

Abstract	INTRODUCTION: To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19. METHODS AND ANALYSIS: DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-ß-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included. ETHICS AND DISSEMINATION: Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04315948 Eudra-CT 2020-000936-23.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #788160
Database	COVID19

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Article ; Online: Protocol for the DisCoVeRy trial

Ader, Florence

BMJ Open

multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults

2020 Volume 10, Issue 9, Page(s) e041437

Abstract: Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for ... ...

Abstract	Introduction To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19. Methods and analysis DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β−1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included. Ethics and dissemination Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals. Trial registration number NCT04315948 Eudra-CT 2020-000936-23.
Keywords	General Medicine ; covid19
Language	English
Publisher	BMJ
Publishing country	uk
Document type	Article ; Online
ZDB-ID	2599832-8
ISSN	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-041437
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Article ; Online: Encephalitis in HIV-negative immunodeficient patients: a prospective multicentre study, France, 2016 to 2019.

Landré, Sophie / Ader, Florence / Epaulard, Olivier / Tattevin, Pierre / Stahl, Jean Paul / Mailles, Alexandra

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

2024 Volume 29, Issue 6

Abstract: BackgroundData on infectious encephalitis in immunodeficient (ID) individuals are scarce. This population may present with atypical clinical symptoms, be infected by uncommon pathogens and develop poor outcomes.AimWe aimed to describe the epidemiology of ...

Abstract	BackgroundData on infectious encephalitis in immunodeficient (ID) individuals are scarce. This population may present with atypical clinical symptoms, be infected by uncommon pathogens and develop poor outcomes.AimWe aimed to describe the epidemiology of infectious encephalitis among HIV-negative ID patients.MethodsPatients from the ENCEIF (Etude Nationale de Cohorte des Encéphalites Infectieuses en France) prospective cohort meeting criteria for infectious encephalitis between January 2016 and December 2019 were included. We compared clinical presentation, magnetic resonance imaging (MRI) results, biological results, infection causes and outcome of ID patients with immunocompetent (IC) patients using Pearson's chi-squared test and Student's t-test. We carried out logistic regression to assess the role of immunodeficiency as risk factor for poor outcome.ResultsID patients (n = 58) were older (mean 72 vs 59 years), had higher prevalence of diabetes (26% vs 12%), pre-existing neurological disorders (12% vs 5%) and higher case-fatality rate (23.6% vs 5.6%) compared to IC patients (n = 436). Varicella zoster virus was the primary cause of encephalitis in ID patients (this aetiology was more frequent in ID (25.9%) than in IC patients (11.5%)), with herpes simplex virus second (22.4% in ID patients vs 27.3% in IC patients). Immunodeficiency was an independent risk factor for death or major sequelae (odds ratio: 3.41, 95%CI: 1.70-6.85).ConclusionsVaricella zoster virus is the most frequent cause of infectious encephalitis in ID patients. Immunodeficiency is a major risk factor for poor outcome. ID encephalitis patients should benefit from stringent investigation of cause and early empiric treatment.
MeSH term(s)	Humans ; Encephalitis/diagnosis ; Encephalitis/epidemiology ; Encephalitis/etiology ; Herpesvirus 3, Human ; HIV Infections/complications ; HIV Infections/epidemiology ; Infectious Encephalitis/complications ; Prospective Studies ; Middle Aged ; Aged
Language	English
Publishing date	2024-02-21
Publishing country	Sweden
Document type	Multicenter Study ; Journal Article
ZDB-ID	1338803-4
ISSN	1560-7917 ; 1025-496X
ISSN (online)	1560-7917
ISSN	1025-496X
DOI	10.2807/1560-7917.ES.2024.29.6.2300046
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Article: Opti-4TB: A protocol for a prospective cohort study evaluating the performance of new biomarkers for active tuberculosis outcome prediction.

Bahuaud, Olivier / Genestet, Charlotte / Hoffmann, Jonathan / Dumitrescu, Oana / Ader, Florence

Frontiers in medicine

2022 Volume 9, Page(s) 998972

Abstract: Introduction: Tuberculosis (TB) treatment requires the combination of multiple anti-TB drugs during 6 months or more depending on strain drug susceptibility profile. Optimizing the monitoring of anti-TB therapy efficacy is required to provide adequate ... ...

Abstract	Introduction: Tuberculosis (TB) treatment requires the combination of multiple anti-TB drugs during 6 months or more depending on strain drug susceptibility profile. Optimizing the monitoring of anti-TB therapy efficacy is required to provide adequate care and prevent drug resistance emergence. Moreover, accurate monitoring tools are needed for the development of strategies aiming at reducing treatment duration. Opti-4TB is a "proof of concept" study aiming at developing a blood-based monitoring of TB outcome by deciphering host immune signatures associated with latency or disease activity through the combination of "omic" methods. The primary objective is to assess the performances of new biomarkers for TB outcome prediction and to determine specific profiles associated with the outcome of treated TB patients. Methods and analysis: Opti-4TB is a prospective, single center study including adult patients hospitalized for pulmonary TB. A workflow will be set up to study the immune status of 40 TB patients and 20 controls with latent TB infection. Blood samples will be collected at four timepoints: before treatment initiation (V1), at day 15 (V2), at 2 months (V3) and at 6 months (V4). Ethics and dissemination: Ethical approval has been obtained from the institutional review board (n°69HCL18_0757). Results will be communicated at scientific meetings and submitted for publication in peer-reviewed journals. Trial registration number: NCT04271397.
Language	English
Publishing date	2022-09-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.998972
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Article: Fatal Community-Acquired Peritonitis Due to Invasive Necrotizing Intestinal Mucormycosis: Case Report and Review of the Literature.

Vassal, Olivia / Dupont, Damien / Ader, Florence / Wallet, Florent / Davigo, Axel / Passot, Guillaume / Persat, Florence / Allaouchiche, Bernard

Turkish journal of anaesthesiology and reanimation

2022 Volume 50, Issue 1, Page(s) 65–67

Abstract: We report here a rare case of fatal rapidly progressive necrotizing gastrointestinal mucormycosis due to Mucor circinelloides f. circinelloides in the setting of community-acquired peritonitis, in an immunocompromised adult patient. Diagnosis was ... ...

Abstract	We report here a rare case of fatal rapidly progressive necrotizing gastrointestinal mucormycosis due to Mucor circinelloides f. circinelloides in the setting of community-acquired peritonitis, in an immunocompromised adult patient. Diagnosis was established by direct examination of peritoneal fluid showing hyphae consistent with mucormycosis confirmed by the culture.
Language	English
Publishing date	2022-03-04
Publishing country	Turkey
Document type	Journal Article
ISSN	2667-677X
ISSN	2667-677X
DOI	10.5152/TJAR.2021.379
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Article ; Online: Final results of the DisCoVeRy trial of remdesivir for patients admitted to hospital with COVID-19.

Ader, Florence / Bouscambert-Duchamp, Maude / Hites, Maya / Peiffer-Smadja, Nathan / Mentré, France / Burdet, Charles

The Lancet. Infectious diseases

2022 Volume 22, Issue 6, Page(s) 764–765

MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; COVID-19/drug therapy ; Clinical Trials as Topic ; Hospitalization ; Humans
Chemical Substances	remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2022-05-25
Publishing country	United States
Document type	Letter
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(22)00295-X
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