Evaluación de la eficacia de la N-acetilcisteína y la bromhexina en comparación con la atención estándar en la prevención de la hospitalización de pacientes ambulatorios con COVID-19: un ensayo clínico aleatorizado doble ciego / Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial

Introducción y objetivo Desde su aparición en diciembre de 2019, la enfermedad por coronavirus causada por el síndrome respiratorio agudo severo coronavirus2 se ha convertido en una emergencia mundial, propagándose rápidamente por todo el mundo. En respuesta a la derivación temprana de estos pacientes a centros de salud ambulatorios, decidimos buscar tratamientos más eficaces en las primeras etapas de su derivación. Este estudio tiene como objetivo prevenir tanto la progresión como el deterioro de las condiciones físicas de los pacientes con COVID-19, reducir la tasa de derivaciones y mitigar los riesgos de hospitalización y de muerte. Material y métodos Realizado en el Centro Terapéutico Dibaj, ciudad de Hamadan, Irán, un ensayo controlado aleatorizado doble ciego abarcó 225 pacientes con COVID-19 de abril a septiembre de 2022. Se obtuvo la aprobación ética de la Universidad de Ciencias Médicas de Hamadan (Aprobación n.° IR.UMSHA .REC.1400.957), con el protocolo registrado en el Registro Iraní de Ensayos Clínicos (Registro n.° IRCT20220302054167N1). Los pacientes cumplieron con el diagnóstico de COVID-19 a través de la presentación de síntomas y la confirmación por PCR, excluyendo aquellos con antecedentes de vacunas y afectación de órganos. Los pacientes con una saturación de oxígeno superior al 92% se asignaron a tres grupos: el grupoA recibió N-acetilcisteína, el grupoB recibió bromhexina y el grupoC recibió atención estándar. Los seguimientos de los niveles de oxígeno, los síntomas y las necesidades de hospitalización se realizaron los días7 y 14, con pacientes hospitalizados monitorizados durante un mes después de la hospitalización. Resultados El estudio encontró que tanto la N-acetilcisteína como la bromhexina pueden reducir efectivamente las tasas de hospitalización y la mortalidad y acortar la duración de la hospitalización... (AU)

Introduction and aim Since its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death. Material and methods Conducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No.: IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19 PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: GroupA received N-acetylcysteine, GroupB received Bromhexine, and GroupC received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization. Results The study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication... (AU)

Evaluación de la eficacia de la N-acetilcisteína y la bromhexina en comparación con la atención estándar en la prevención de la hospitalización de pacientes ambulatorios con COVID-19: un ensayo clínico aleatorizado doble ciego / Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial

Introducción y objetivo Desde su aparición en diciembre de 2019, la enfermedad por coronavirus causada por el síndrome respiratorio agudo severo coronavirus2 se ha convertido en una emergencia mundial, propagándose rápidamente por todo el mundo. En respuesta a la derivación temprana de estos pacientes a centros de salud ambulatorios, decidimos buscar tratamientos más eficaces en las primeras etapas de su derivación. Este estudio tiene como objetivo prevenir tanto la progresión como el deterioro de las condiciones físicas de los pacientes con COVID-19, reducir la tasa de derivaciones y mitigar los riesgos de hospitalización y de muerte. Material y métodos Realizado en el Centro Terapéutico Dibaj, ciudad de Hamadan, Irán, un ensayo controlado aleatorizado doble ciego abarcó 225 pacientes con COVID-19 de abril a septiembre de 2022. Se obtuvo la aprobación ética de la Universidad de Ciencias Médicas de Hamadan (Aprobación n.° IR.UMSHA .REC.1400.957), con el protocolo registrado en el Registro Iraní de Ensayos Clínicos (Registro n.° IRCT20220302054167N1). Los pacientes cumplieron con el diagnóstico de COVID-19 a través de la presentación de síntomas y la confirmación por PCR, excluyendo aquellos con antecedentes de vacunas y afectación de órganos. Los pacientes con una saturación de oxígeno superior al 92% se asignaron a tres grupos: el grupoA recibió N-acetilcisteína, el grupoB recibió bromhexina y el grupoC recibió atención estándar. Los seguimientos de los niveles de oxígeno, los síntomas y las necesidades de hospitalización se realizaron los días7 y 14, con pacientes hospitalizados monitorizados durante un mes después de la hospitalización. Resultados El estudio encontró que tanto la N-acetilcisteína como la bromhexina pueden reducir efectivamente las tasas de hospitalización y la mortalidad y acortar la duración de la hospitalización... (AU)

Introduction and aim Since its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death. Material and methods Conducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No.: IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19 PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: GroupA received N-acetylcysteine, GroupB received Bromhexine, and GroupC received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization. Results The study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication... (AU)

Evaluation of the efficacy of N-acetylcysteine and bromhexine compared with standard care in preventing hospitalization of outpatients with COVID-19: a double blind randomized clinical trial.

INTRODUCTION AND AIM: Since its emergence in December 2019, the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 has become a global emergency, spreading rapidly worldwide. In response to the early referral of these patients to outpatient health centers, we decided to seek more effective treatments in the early stages of their referral. This study aims to prevent both the progression and deterioration of the physical conditions of COVID-19 patients, reduce the rate of referrals, and mitigate the risks of hospitalization and death. MATERIAL AND METHODS: Conducted at Dibaj Therapeutic Center, Hamadan City, Iran, a double-blind randomized controlled trial encompassed 225 COVID-19 patients from April to September 2022. Ethical approval was obtained from Hamadan University of Medical Sciences (Approval No.: IR.UMSHA.REC.1400.957), with the protocol registered in the Iranian Registry of Clinical Trials (Registration No. : IRCT20220302054167N1). In this study, we included patients who tested positive for COVID-19- PCR and were symptomatic, excluding those who were pregnant or had received a COVID-19 vaccine. Patients with oxygen saturation above 92% were allocated to three groups: Group A received N-acetylcysteine, Group B received Bromhexine, and Group C received standard care. Follow-ups on oxygen levels, symptoms, and hospitalization needs were conducted on days 7 and 14, with hospitalized patients monitored for one month post-hospitalization. RESULTS: The study found that both N-acetylcysteine and Bromhexine can effectively reduce hospitalization rates and mortality and shorten the duration of hospitalization. The third visit of patients who received N-acetylcysteine showed an increase of 1.33% in oxygen saturation compared to their first visit, and in patients who received Bromhexine, this increase was 1.19%. The mortality rate was 9.33% in the control group and zero in both groups of patients who received medication. CONCLUSION: In conclusion, the results of this study indicate that NAC and bromhexine may be effective in the treatment of patients with positive COVID-19, with a lower hospitalization rate, shorter hospitalization, faster recovery time, and reduced mortality compared to the control group.