13 research outputs found

    High mean arterial pressure target to improve sepsis-associated acute kidney injury in patients with prior hypertension: a feasibility study

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    Background : The optimal mean arterial pressure (MAP) in cases of septic shock is still a matter of debate in patients with prior hypertension. An MAP between 75 and 85 mmHg can improve glomerular filtration rate (GFR) but its effect on tubular function is unknown. We assessed the effects of high MAP level on glomerular and tubular renal function in two intensive care units of a teaching hospital. Inclusion criteria were patients with a history of chronic hypertension and developing AKI in the first 24 h of septic shock. Data were collected during two 6 h periods of MAP regimen administered consecutively after haemodynamic stabilisation in an order depending on the patient's admission unit: a high-target period (80–85 mmHg) and a low-target period (65–70 mmHg). The primary endpoint was the creatinine clearance (CrCl) calculated from urine and serum samples at the end of each MAP period by the UV/P formula. Results : 26 patients were included. Higher urine output (+0.2 (95%:0, 0.4) mL/kg/h; P = 0.04), urine sodium (+6 (95% CI 0.2, 13) mmol/L; P = 0.04) and lower serum creatinine (− 10 (95% CI − 17, − 3) ”mol/L; P = 0.03) were observed during the high-MAP period as compared to the low-MAP period, resulting in a higher CrCl (+25 (95% CI 11, 39) mL/mn; P = 0.002). The urine creatinine, urine–plasma creatinine ratio, urine osmolality, fractional excretion of sodium and urea showed no significant variation. The KDIGO stage at inclusion only interacted with serum creatinine variation and low level of sodium excretion at inclusion did not interact with these results. Conclusions : In the early stage of sepsis-associated AKI, a high-MAP target in patients with a history of hypertension was associated with a higher CrCl, but did not affect the kidneys' ability to concentrate urine, which may reflect no effect on tubular function

    AprĂšs le 10 mai, les Ă©lections font-elles l’autogestion ? Éditorial

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    Savoye Antoine, Weill Claudie, Guillot Marie-France, Davreux Pierre, Mintz Frank, Duvignaud Jean, Laville Jean-Louis, Hess RĂ©mi, Schu Patrice, Guillerm Alain, DecouflĂ© AndrĂ©-ClĂ©ment, Marty Marie-Odile, Lourau RenĂ©, Guigou Jacques, Varro Gabrielle, Corpet Olivier, Condominas Bernard, MothĂ© Daniel, Chapuis Robert, Bourdet Yvon, Pluet Jacqueline, Person Yves. AprĂšs le 10 mai, les Ă©lections font-elles l’autogestion ? Éditorial . In: Autogestions, NS N°6, 1981. Les habits neufs du prĂ©sident Tito. Critique sociale, rĂ©pression politique et luttes ouvriĂšres en Yougoslavie. pp. 141-153

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    ESSAI RANDOMISÉ POUR ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ DE TRAITEMENTS CHEZ DES PATIENTS AMBULATOIRES ATTEINTS DE COVID-19 AYANT DES FACTEURS DE RISQUE ESSAI COVERAGE FRANCE : PRÉSENTATION DU PROTOCOLE

    No full text
    International audienceContext. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level.Contexte. La pandĂ©mie de Covid-19 a eu d’importantes rĂ©percussions sanitaires et sociales. Les acteurs de soins primaires, en particulier les spĂ©cialistes de mĂ©decine gĂ©nĂ©rale, prennent en charge la majoritĂ© des patients atteints de Covid-19. Un traitement prĂ©coce initiĂ© en premiĂšre ligne, notamment chez les patients Ă  risque d’aggravation, pourrait rĂ©duire les taux d’hospitalisation et de dĂ©cĂšs. Aucun traitement n’est actuellement validĂ© dans cette indication.Objectif. Évaluer l’efficacitĂ© et la tolĂ©rance de traitements expĂ©rimentaux administrĂ©s Ă  un stade prĂ©coce, en ambulatoire, dans le but de diminuer le risque de dĂ©velopper une forme sĂ©vĂšre de la maladie chez des patients atteints de Covid-19 ayant des facteurs de risque d’aggravation et qui n’ont pas de critĂšres d’hospitalisation.MĂ©thodes. Essai thĂ©rapeutique contrĂŽlĂ© randomisĂ© multicentrique, en ouvert, multi-bras, multi-Ă©tapes (MAMS) comprenant une phase pilote d’évaluation de la tolĂ©rance et une phase d’évaluation de l’efficacitĂ©. L’efficacitĂ© sera Ă©valuĂ©e par la proportion de participants ayant eu une indication d’hospitalisation, une indication d’oxygĂ©nothĂ©rapie aiguĂ« (en raison de la Covid-19), ou dĂ©cĂ©dĂ©s entre J0 et J14 dans le groupe traitement expĂ©rimental par rapport au groupe tĂ©moin. RĂ©sultats attendus. Cet essai permettra d’évaluer la tolĂ©rance et l’efficacitĂ© de l’administration prĂ©coce de divers traitements dans le cadre de la Covid-19 chez des patients Ă  risque de dĂ©velopper des formes graves. Il fournira Ă©galement des informations susceptibles d’amĂ©liorer la recherche clinique interventionnelle impliquant la personne humaine en soins primaires et sa structuration

    Randomized trial to evaluate the safety and efficacy of outpatient treatments in individuals with Covid-19 with risk factors. COVERAGE France Trial: a structured summary

    No full text
    Context. The Covid-19 pandemic is of unprecedented magnitude and has had major social and health consequences. Primary care professionals, mainly general practitioners, ensure the care of most patients with Covid-19. An early-stage treatment administered to patients with risk factors for developing a severe disease could reduce hospitalization and death rates. No treatment is currently validated in this indication. Objectives. To evaluate the safety and efficacy of experimental candidate agents delivered in outpatient settings to reduce the risk of hospitalization or death in at-risk patients with early-stage proven Covid-19 and no indication for hospital admission. Methods. Multicentric, open-label, multi-arm, multi-stage (MAMS) randomized controlled trial with a pilot tolerability and safety phase, and a clinical efficacy phase. Efficacy will be determined by the proportion of participants who have an indication for hospital admission, administration of acute oxygen therapy (because of Covid-19) or who decease between D0 and D14 in the experimental treatment group compared to the control group. Expected results. This trial will assess the tolerance and efficacy of diverse treatments administered at an early stage of Covid-19, in patients with risk factors of developing a severe disease. It will also provide information that can contribute to increase primary care actors' ability to conduct clinical trials at the national level
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