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Trials ; 21(1): 882, 2020 Oct 26.
Artículo en Inglés | MEDLINE | ID: covidwho-892369


OBJECTIVES: We will evaluate the efficacy and safety of Melatonin, compared to the standard therapeutic regimen on clinical symptoms and serum inflammatory parameters in patients with confirmed COVID-19, who are moderately ill. TRIAL DESIGN: This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: All patients admitted to Severe Acute Respiratory Syndrome Departments of Shahid Mohammadi Hospital, Bandar Abbas, Iran will be screened for the following criteria. INCLUSION CRITERIA: 1. Age ≥20 years 2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction). 3. Moderate COVID-19 pneumonia (via computed tomography and or X-ray imaging), requiring hospitalization. 4. Hospitalized ≤48 hours. 5. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. EXCLUSION CRITERIA: 1. Underlying diseases, including chronic hypertension, diabetes mellitus, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, corticosteroids, hormonal drugs, alcohol, other antiviral and investigational medicines, and illegal drugs (during the last 30 days). 4. History of known allergy to Melatonin. 5. Pregnancy and breastfeeding. INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education's protocol, along with Melatonin capsules at a dose of 50 mg daily for a period of seven days. CONTROL GROUP: The standard therapeutic regimen for COVID-19 along with Melatonin-like placebo capsules at a dose of one capsule daily for a period of seven days. Both Melatonin and placebo capsules were prepared at the Faculty of Pharmacy and Pharmaceutical Sciences, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. MAIN OUTCOMES: The primary outcomes are the recovery rate of clinical symptoms and oxygen saturation as well as improvement of serum inflammatory parameters, including C-reactive protein, tumor necrosis factor-alpha (TNF-ɑ), interleukin-1ß (IL-1ß), and IL-6 within seven days of randomization. The secondary outcomes are the time to improve clinical and paraclinical features along with the incidence of serious adverse drug reactions within seven days of randomization. RANDOMIZATION: Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. BLINDING (MASKING): All study participants, clinicians, nurses, research coordinators, and those analyzing the data are blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 patients randomized into two groups (30 in each group). TRIAL STATUS: The trial protocol is Version 1.0, August 14, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by November 30, 2020. TRIAL REGISTRATION: The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N5 ". The registration date was 14 August 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Betacoronavirus/efectos de los fármacos , Depresores del Sistema Nervioso Central/uso terapéutico , Infecciones por Coronavirus/tratamiento farmacológico , Melatonina/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Adulto , Betacoronavirus/genética , Biomarcadores/sangre , Estudios de Casos y Controles , Depresores del Sistema Nervioso Central/administración & dosificación , Depresores del Sistema Nervioso Central/efectos adversos , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/virología , Método Doble Ciego , Hospitalización , Humanos , Irán/epidemiología , Melatonina/administración & dosificación , Melatonina/efectos adversos , Oxígeno/sangre , Pandemias , Placebos/administración & dosificación , Neumonía Viral/diagnóstico , Neumonía Viral/virología , Seguridad , Factores de Tiempo , Resultado del Tratamiento
Psychosomatics ; 61(6): 585-596, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-726823


BACKGROUND: The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as one of the biggest health threats of our generation. A significant portion of patients are presenting with delirium and neuropsychiatric sequelae of the disease. Unique examination findings and responses to treatment have been identified. OBJECTIVE: In this article, we seek to provide pharmacologic and treatment recommendations specific to delirium in patients with COVID-19. METHODS: We performed a literature search reviewing the neuropsychiatric complications and treatments in prior coronavirus epidemics including Middle Eastern respiratory syndrome and severe acute respiratory syndrome coronaviruses, as well as the emerging literature regarding COVID-19. We also convened a work group of consultation-liaison psychiatrists actively managing patients with COVID-19 in our hospital. Finally, we synthesized these findings to provide preliminary pharmacologic recommendations for treating delirium in these patients. RESULTS: Delirium is frequently found in patients who test positive for COVID-19, even in the absence of respiratory symptoms. There appears to be a higher rate of agitation, myoclonus, abulia, and alogia. No data are currently available on the treatment of delirium in patients with COVID-19. Extrapolating from general delirium treatment, Middle Eastern respiratory syndrome/severe acute respiratory syndrome case reports, and our experience, preliminary recommendations for pharmacologic management have been assembled. CONCLUSIONS: COVID-19 is associated with neuropsychiatric symptoms. Low-potency neuroleptics and alpha-2 adrenergic agents may be especially useful in this setting. Further research into the pathophysiology of COVID-19 will be key in developing more targeted treatment guidelines.

Agonistas de Receptores Adrenérgicos alfa 2/uso terapéutico , Antipsicóticos/uso terapéutico , Encefalopatías/fisiopatología , Infecciones por Coronavirus/fisiopatología , Delirio/tratamiento farmacológico , Agonistas de Dopamina/uso terapéutico , Neumonía Viral/fisiopatología , Betacoronavirus , Encefalopatías/psicología , Depresores del Sistema Nervioso Central/uso terapéutico , Infecciones por Coronavirus/psicología , Delirio/fisiopatología , Delirio/psicología , Moduladores del GABA/uso terapéutico , Humanos , Lorazepam/uso terapéutico , Melatonina/uso terapéutico , Pandemias , Neumonía Viral/psicología , Guías de Práctica Clínica como Asunto
Psychosomatics ; 61(5): 544-550, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-616923

Agonistas de Receptores Adrenérgicos alfa 2/uso terapéutico , Antipsicóticos/uso terapéutico , Infecciones por Coronavirus/terapia , Delirio/tratamiento farmacológico , Hipnóticos y Sedantes/efectos adversos , Neumonía Viral/terapia , Agitación Psicomotora/tratamiento farmacológico , Fármacos Inductores del Sueño/uso terapéutico , Anciano , Analgésicos Opioides/efectos adversos , Azepinas/uso terapéutico , Betacoronavirus , Depresores del Sistema Nervioso Central/uso terapéutico , Clordiazepóxido/efectos adversos , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/psicología , Delirio/etiología , Delirio/fisiopatología , Delirio/psicología , Dexmedetomidina/efectos adversos , Femenino , Guanfacina/uso terapéutico , Haloperidol/uso terapéutico , Humanos , Hidromorfona/efectos adversos , Unidades de Cuidados Intensivos , Ketamina/efectos adversos , Melatonina/uso terapéutico , Midazolam/efectos adversos , Oxicodona/efectos adversos , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/fisiopatología , Neumonía Viral/psicología , Propofol/efectos adversos , Agitación Psicomotora/etiología , Agitación Psicomotora/fisiopatología , Agitación Psicomotora/psicología , Respiración Artificial , Trastornos del Sueño del Ritmo Circadiano/tratamiento farmacológico , Trastornos del Sueño del Ritmo Circadiano/etiología , Trastornos del Sueño del Ritmo Circadiano/fisiopatología , Traqueostomía , Triazoles/uso terapéutico , Ácido Valproico/uso terapéutico