Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 250
Filtrar
Añadir filtros

Base de datos
Intervalo de año
2.
Trials ; 21(1): 499, 2020 06 08.
Artículo en Inglés | MEDLINE | ID: covidwho-768581

RESUMEN

OBJECTIVES: The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN: This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS: Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR: The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES: The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION: Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING): The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS: Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Betacoronavirus/inmunología , Infecciones por Coronavirus/terapia , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Adulto , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , Ensayos Clínicos Fase II como Asunto , Humanos , Inmunización Pasiva/efectos adversos , Inmunización Pasiva/métodos , Pandemias , Estudios Prospectivos
3.
Br J Nurs ; 29(16): 948-953, 2020 Sep 10.
Artículo en Inglés | MEDLINE | ID: covidwho-750358

RESUMEN

This article discusses the background to the current COVID-19 pandemic. The specific features of the causative pathogen (SARS-CoV-2) are outlined, together with a 'whistlestop' revision of immunological principles. The article goes on to discuss the principles and mechanisms of immunisation and the stages of vaccine development. The current situation in relation to the race to develop a vaccine against COVID-19 is incorporated and the immunological principles being adapted by the top contenders are outlined. These include new approaches based on genetic sequencing. Finally, the importance of understanding theoretical principles and the potential practical implications for nurses who will be at the coalface, reassuring patients and delivering vaccines, is addressed.


Asunto(s)
Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Ensayos Clínicos Fase III como Asunto , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/enfermería , Humanos , Neumonía Viral/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Vacunas Virales
4.
Trials ; 21(1): 765, 2020 Sep 05.
Artículo en Inglés | MEDLINE | ID: covidwho-745677

RESUMEN

Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.


Asunto(s)
Betacoronavirus/patogenicidad , Infecciones por Coronavirus/virología , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Proyectos de Investigación , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Terminación Anticipada de los Ensayos Clínicos , Humanos , Pandemias , Seguridad del Paciente , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Opinión Pública , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo
5.
Trials ; 21(1): 766, 2020 Sep 05.
Artículo en Inglés | MEDLINE | ID: covidwho-745676

RESUMEN

OBJECTIVES: To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. To study the effect of GA on the level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load. Secondary outcomes will be the effect of GA oral intake on mortality rate and days of hospital admission. TRIAL DESIGN: Quadruple blind, randomized placebo-controlled clinical trial Phase II & III. Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio) superiority trial of oral GA among seropositive COVID-19 patients. PARTICIPANTS: Inclusion criteria: COVID-19 infected (newly diagnosed) as proved by real-time PCR within 72 hours of PCR. Age 8-90 years Both genders Exclusion criteria: Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan. INTERVENTION AND COMPARATOR: Experimental: Intervention Group This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose once daily for four weeks Placebo Comparator: Control group: This group will be provided with pectin powder provided as one-gram-dose once daily for four weeks Both GA and placebo will be in addition to standard care treatment based on local clinical guidelines. MAIN OUTCOMES: Mean change from baseline score of Immune Response to end of the trial. Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization). Mortality rate: The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]). RANDOMISATION: Randomization (1:1 allocation ratio) and will be conducted using a sequence of computer-generated random numbers by an independent individual. Each participating centre will be assigned a special code generated by the computer. The randomization will be kept by the PI and a research assistant. BLINDING (MASKING): Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups. TRIAL STATUS: Protocol Version no 2, 30th June 2020. Recruitment will start on 15th September 2020. The intended completion date is 15th January 2021. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04381871 . Date of trial registration: 11 May 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 dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Goma Arábiga/uso terapéutico , Factores Inmunológicos/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Betacoronavirus/inmunología , Betacoronavirus/patogenicidad , Niño , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Femenino , Goma Arábiga/efectos adversos , Interacciones Microbiota-Huesped , Humanos , Factores Inmunológicos/efectos adversos , Masculino , Persona de Mediana Edad , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/inmunología , Neumonía Viral/virología , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
6.
Trials ; 21(1): 758, 2020 Sep 03.
Artículo en Inglés | MEDLINE | ID: covidwho-745011

RESUMEN

OBJECTIVES: Tocilizumab is a humanized monoclonal antibody which targets and inhibits interleukin-6 (IL-6) and has demonstrated efficacy in treating diseases associated with hyper-inflammation. Data are suggestive of tocilizumab as a potential treatment for patients with COVID-19 infection. The aim of this study is to determine the safety and efficacy of standard dose versus low dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation on time to intubation, non-invasive ventilation and/or all-cause mortality. TRIAL DESIGN: This trial is a phase 2, open label, two-stage, multicentre, randomised trial. PARTICIPANTS: Adult subjects with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation requiring admission to hospital at St. Vincent's University Hospital and Mater Misericordiae University Hospital, Dublin, Ireland. Inclusion criteria Aged 18 years or older. Confirmed SARS-CoV2 infection (as defined by positive PCR). Evidence of hyper inflammatory state as evidenced by at least three of the following: Documented temperature >38°C in the past 48 hours, IL6 >40 pg/ml, or in its absence D-dimer >1.5 µgFEU /ml, Elevated CRP (>100mg/L) and/or a three-fold increase since presentation, Elevated ferritin X5 ULN, Elevated LDH (above the ULN), Elevated fibrinogen (above the ULN). Pulmonary infiltrates on chest imaging. Moderate to severe respiratory failure as defined by PaO2/FiO2≤300mmHg. INTERVENTION AND COMPARATOR: Intervention for participants in this trial is SOC plus Tocilizumab compared to SOC alone (comparator). For Stage 1, following randomisation, subjects will receive either (Arm 1) SOC alone or (Arm 2) SOC plus Tocilizumab (standard single dose - 8mg/kg, infused over 60 minutes. Once stage 1 has fully recruited, subsequent participants will be enrolled directly into Stage 2 and receive either (Arm 1) SOC plus Tocilizumab (standard single dose - 8mg/kg, infused over 60 minutes or (Arm 2) SOC plus Tocilizumab (standard single dose - 4mg/kg, infused over 60 minutes). MAIN OUTCOMES: The primary endpoint for this study is the time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death within 28 days post randomisation. RANDOMISATION: Eligible patients will be randomised (1:1) using a central register. Randomisation will be performed through an interactive, web-based electronic data capturing database. In stage 1, eligible participants will be randomised (1:1) to (Arm 1) SOC alone or to (Arm 2) SOC with single dose (8mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes. In stage 2, eligible participants will be randomised (1:1) to receive either (Arm 1) single, standard dose (8mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes or (Arm 2) reduced dose (4mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes. BLINDING: This study is open label. The study will not be blinded to investigators, subjects, or medical or nursing staff. The trial statistician will be blinded for data analysis and will be kept unaware of treatment group assignments. To facilitate this, the randomisation schedule will be drawn up by an independent statistician and objective criteria were defined for the primary outcome to minimize potential bias. NUMBERS TO BE RANDOMISED: In stage 1, 90 subjects will be randomised 1:1, 45 to SOC and 45 subjects to SOC plus Tocilizumab (8mg/kg, infused over 60 minutes). In stage 2, sample size calculation for the dose evaluation stage will use data generated from stage 1 using the same primary endpoint as in stage 1. TRIAL STATUS: The COVIRL002 trial (Protocol version 1.4, 13th May 2020) commenced in May 2020 at St. Vincent's University Hospital and Mater Misericordiae University Hospital, Dublin, Ireland. Recruitment is proceeding with the aim to achieve the target sample size on or before April 2021. TRIAL REGISTRATION: COVIRL002 was registered 25 June 2020 under EudraCT number: 2020-001767-86 and Protocol identification: UCDCRC/20/02. FULL PROTOCOL: The full protocol for COVIRL002 is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Asunto(s)
Antiinflamatorios/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Antiinflamatorios/efectos adversos , Anticuerpos Monoclonales Humanizados/efectos adversos , Betacoronavirus/patogenicidad , Ensayos Clínicos Fase II como Asunto , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Progresión de la Enfermedad , Interacciones Microbiota-Huesped , Humanos , Intubación Intratraqueal , Irlanda , Estudios Multicéntricos como Asunto , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/mortalidad , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento
7.
Cien Saude Colet ; 25(9): 3517-3554, 2020 Sep.
Artículo en Inglés, Portugués | MEDLINE | ID: covidwho-740424

RESUMEN

This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.


Asunto(s)
Infecciones por Coronavirus/tratamiento farmacológico , Neumonía Viral/tratamiento farmacológico , Síndrome Respiratorio Agudo Grave/tratamiento farmacológico , Antimaláricos/administración & dosificación , Antivirales/administración & dosificación , Betacoronavirus/efectos de los fármacos , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/virología , Humanos , Coronavirus del Síndrome Respiratorio de Oriente Medio/efectos de los fármacos , Coronavirus del Síndrome Respiratorio de Oriente Medio/aislamiento & purificación , Pandemias , Neumonía Viral/virología , Ensayos Clínicos Controlados Aleatorios como Asunto , Virus del SRAS/efectos de los fármacos , Virus del SRAS/aislamiento & purificación , Síndrome Respiratorio Agudo Grave/virología
8.
Cien Saude Colet ; 25(9): 3365-3376, 2020 Sep.
Artículo en Inglés, Portugués | MEDLINE | ID: covidwho-740421

RESUMEN

OBJECTIVES: to evaluate the effectiveness of non-woven face masks for the prevention of respiratory infections (MERS CoV, SARS-CoV, and SARS-CoV-2) in the population. METHODS: search in Medline, Embase, Cinahl, The Cochrane Library, Trip databases. Google Scholar, Rayyan and medRxiv were also consulted for complementary results. No filters related to date, language or publication status were applied. Titles and abstracts were screened, and later, full texts were evaluated. RESULTS: three studies were included: a randomized cluster clinical trial and two systematic reviews. The clinical trial indicates a potential benefit of medical masks to control the source of clinical respiratory disease infection. In one of the systematic reviews, it was not possible to establish a conclusive relationship between the use of the mask and protection against respiratory infection. Finally, another systematic review indicated that masks are effective in preventing the spread of respiratory viruses. CONCLUSION: Evidence points to the potential benefit of standard non-woven face masks. For the current pandemic scenario of COVID-19, education on the appropriate use of masks associated with individual protection measures is recommended.


Asunto(s)
Infecciones por Coronavirus/prevención & control , Máscaras , Pandemias/prevención & control , Neumonía Viral/prevención & control , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Humanos , Coronavirus del Síndrome Respiratorio de Oriente Medio/aislamiento & purificación , Neumonía Viral/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Infecciones del Sistema Respiratorio/epidemiología , Infecciones del Sistema Respiratorio/prevención & control , Infecciones del Sistema Respiratorio/virología , Virus del SRAS/aislamiento & purificación , Síndrome Respiratorio Agudo Grave/epidemiología , Síndrome Respiratorio Agudo Grave/prevención & control , Síndrome Respiratorio Agudo Grave/virología
9.
Medicine (Baltimore) ; 99(35): e21723, 2020 Aug 28.
Artículo en Inglés | MEDLINE | ID: covidwho-740202

RESUMEN

BACKGROUND: Novel coronavirus pneumonia (COVID-19) has become a worldwide epidemic, causing huge loss of life and property. Because of its unique pathological mechanism, diabetes affects the prognosis of patients with COVID-19 in many aspects. At present, there are many controversies about whether angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB) should be used in the treatment of patients with diabetes mellitus and COVID-19 comorbidities. There is an urgent need to provide evidence for the use of ACEI/ARB through high-quality systematic evaluation and meta-analysis. METHODS: We will search electronic databases including PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, and Wanfang database using keywords related to COVID-19, diabetes mellitus, ACEI/ARB drugs, and randomized controlled trials . We will manually search gray literature, such as conference proceedings and academic degree dissertations, and trial registries. Two independent reviewers will screen studies, extract data, and evaluate risk of bias. Data analysis will be conducted using the Review Manager software version 5.3.5 and stata 14.0 software for Mac. Statistical heterogeneity will be assessed using a standard chi-square test with a significance level of P < .10. Biases associated with study will be investigated using funnel plots. RESULTS: This study will provide a high-quality synthesis of efficacy and safety of ACEI/ARB drugs in patients with COVID-19 combined with diabetes mellitus, providing evidence for clinical treatment of diabetes mellitus combined with COVID-19. And the results will be published at a peer-reviewed journal. CONCLUSION: Our study will draw conclusions on the efficacy and safety of ACEI / ARB drugs in patients with diabetes mellitus complicated with covid-19, so as to provide theoretical guidance for clinical practice of diabetes mellitus with covid-19. INPLASY REGISTRATION NUMBER: INPLASY 202060111.


Asunto(s)
Antagonistas de Receptores de Angiotensina/farmacología , Inhibidores de la Enzima Convertidora de Angiotensina/farmacología , Infecciones por Coronavirus , Diabetes Mellitus , Administración del Tratamiento Farmacológico/normas , Pandemias , Neumonía Viral , Betacoronavirus , Comorbilidad , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/epidemiología , Humanos , Neumonía Viral/epidemiología , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
10.
Medicine (Baltimore) ; 99(33): e21618, 2020 Aug 14.
Artículo en Inglés | MEDLINE | ID: covidwho-740197

RESUMEN

BACKGROUND: Coronavirus disease 2019, (COVID-19) is a major problem in public health in the world. Up to June, 2020, the number of infections arising to 8,690,000 and cause 410,000 deaths all over the world. Identification the clinical symptoms from non-severe to severe is important for clinician. This meta-analysis aimed to compare the clinical symptoms between severe and non-severe COVID-19 pneumonia. METHODS: Electronic databases including PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure database, Wanfang Database and Chinese Biomedical Literature Database were searched from its inception to June 21, 2020. We only included severe versus non-severe COVID-19 pneumonia patients and pooled results were summarized by STATA 12.0 software.Two researchers independently selected the study and assessed the quality of the included studies. The heterogeneity was measured by I tests (I < 50 indicates little heterogeneity, I≥50 indicates high heterogeneity). Publication bias was ruled out by funnel plot and statistically assessed by Begg test (P > .05 as no publication bias). RESULTS: Results will be published in relevant peer-reviewed journals. CONCLUSION: Our study aims to systematically present the clinical symptoms between non-severe and severe of COVID-19 patients, which will be provide clinical guidance for COVID-19 patients.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/diagnóstico , Índice de Severidad de la Enfermedad , Evaluación de Síntomas/métodos , Estudios de Cohortes , Femenino , Humanos , Masculino , Metaanálisis como Asunto , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto
11.
Medicine (Baltimore) ; 99(33): e21484, 2020 Aug 14.
Artículo en Inglés | MEDLINE | ID: covidwho-740193

RESUMEN

BACKGROUND: The objective of this study is to investigate the effects of humanistic care and psychological counseling (HCPC) on psychological disorders (PD) in medical students after coronavirus disease 2019 (COVID-19) outbreak. METHODS: We will search randomized controlled trials or case-controlled studies of HCPC on PD in medical students after COVID-19 outbreak in the following electronic databases: PUBMED/MEDLINE, EMBASE, Cochrane Library, CINAHL, AMED, WANGFANG, and CNKI. The time is restricted from the construction of each database to the present. All process of study selection, data collection, and study quality evaluation will be carried out by two independent authors. Any different opinions will be solved by a third author through discussion. We will employ RevMan 5.3 software to conduct statistical analysis. RESULTS: This study will provide a better understanding of HCPC on PD in medical students after COVID-19 outbreak. CONCLUSIONS: This study may offer strong evidence for clinical practice to treat PD in medical students after COVID-19 outbreak. STUDY REGISTRATION: CRD42020193199.


Asunto(s)
Infecciones por Coronavirus/psicología , Consejo/métodos , Trastornos Mentales/terapia , Neumonía Viral/psicología , Psicoterapia/métodos , Estudiantes de Medicina/psicología , Adulto , Betacoronavirus , Estudios de Casos y Controles , Femenino , Humanismo , Humanos , Masculino , Trastornos Mentales/psicología , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Adulto Joven
12.
Medicine (Baltimore) ; 99(33): e21034, 2020 Aug 14.
Artículo en Inglés | MEDLINE | ID: covidwho-740189

RESUMEN

BACKGROUND: The aim of this systematic review and meta-analysis is to assess effectiveness and safety of Chinese medicine (CM) as complementary therapy in treating coronavirus disease 2019 (COVID-19). METHODS: The following databases will be searched: PubMed, Cochrane, Embase, China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, and Wanfang database from October 1, 2019 to March 1, 2020. Randomized trials and quasi-randomized or prospective controlled clinical trials of CM that reported data on COVID-19 patients will be included. Study selection, data extraction, quality assessment, and assessment of risk bias will be performed by 2 reviewers independently. Odds ratios and correlative 95% confidence intervals will be calculated to present the association between the CM and CWM using Review Manager version 5.3 when there is sufficient available data. RESULTS: The results will be disseminated through a peer-reviewed journal publication. CONCLUSION: This systematic review findings will summarize up-to-date evidence for that CM is more effective and safe as adjunctive treatment for patients with COVID-19. ETHICS AND DISSEMINATION: Ethics approval and patient consent are not required as this study is a systematic review based on published articles. PROSPERO REGISTRATION NUMBER: CRD42020185382.


Asunto(s)
Betacoronavirus , Terapias Complementarias/métodos , Infecciones por Coronavirus/terapia , Medicamentos Herbarios Chinos/uso terapéutico , Neumonía Viral/terapia , Adulto , Anciano , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/virología , Femenino , Humanos , Masculino , Medicina China Tradicional/métodos , Metaanálisis como Asunto , Persona de Mediana Edad , Oportunidad Relativa , Pandemias , Neumonía Viral/virología , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
14.
Medicine (Baltimore) ; 99(34): e21873, 2020 Aug 21.
Artículo en Inglés | MEDLINE | ID: covidwho-733316

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19), a new type of coronavirus, first reported in Wuhan, China at the end of December 2019. As a result of the worldwide outbreak, the number of patients continues to increase. With multiple therapeutic interventions, more and more patients are recovering. Fire needle is used as an alternative therapy. At present, there are no relevant articles for systematic review and meta-analysis, so this study will evaluate the efficacy and safety of fire needle in the treatment of COVID-19 pneumonia. METHODS: The following electronic bibliographic databases will be searched to identify relevant studies from December 2019 to December 2020: MEDLINE, PubMed, Embase, Cochrane library, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Technical Periodicals (VIP), Wan-fang data, Chinese Biological Medicine Database (CBM), and other databases. All included articles were randomized controlled trial without any language restrictions. Two reviewers will independently conduct cations retrieval, de-duplication, filtering, quality assessment, and data analysis by the Review Manager (V.5.3). Meta-analysis, subgroup analysis and/or descriptive analysis were performed on the included data. DISCUSSION: This study will investigate the application of fire needle in the treatment or prevention of COVID-19, and provide a high-quality synthesis to evaluate whether fire needle is an effective and safe intervention for COVID-19. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD 42020193703.


Asunto(s)
Infecciones por Coronavirus/terapia , Medicina China Tradicional/métodos , Neumonía Viral/terapia , Betacoronavirus , China , Humanos , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
16.
Crit Care Nurs Q ; 43(4): 390-399, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-729219

RESUMEN

Coronavirus disease-2019 (COVID-19) creates severe respiratory distress and often a cascade of other systemic complications impacting several organ systems. The immune response includes a cytokine storm that creates many life-threatening problems including coagulopathies, arrhythmias, and secondary infections. This article discusses the multisystem responses to the physical insults created by this corona virus.


Asunto(s)
Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Sistema Cardiovascular/virología , Tracto Gastrointestinal/virología , Humanos , Sistema Inmunológico/virología , Integumento Común/virología , Riñón/virología , Sistema Musculoesquelético/virología , Sistema Nervioso/virología , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Sistema Respiratorio/virología
17.
Crit Care Nurs Q ; 43(4): 369-380, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-729217

RESUMEN

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infection can vary from asymptomatic to severe symptoms. It can lead to respiratory failure and acute respiratory distress syndrome requiring intubation and mechanical ventilation. Triaging patients is key to prevent spread, conserving medical resources, and providing appropriate care. The treatment of these patients remains supportive. Respiratory failure due to the virus should be managed by providing supplemental oxygen and early intubation. Some patients develop acute respiratory distress syndrome and refractory hypoxemia. In this article, we review the 2 phenotypes of respiratory failure, mechanical ventilation and the management of refractory hypoxemia.


Asunto(s)
Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Insuficiencia Respiratoria/terapia , Insuficiencia Respiratoria/virología , Infecciones por Coronavirus/prevención & control , Humanos , Intubación , Pandemias/prevención & control , Fenotipo , Neumonía Viral/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial , Triaje
18.
Crit Care Nurs Q ; 43(4): 349-368, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-729216

RESUMEN

Coronavirus disease 2019 (COVID-19) has resulted in an unprecedented pandemic, challenging practitioners to identify safe and effective therapeutic options in a limited amount of time. The rapid genomic sequencing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provided a significant number of therapeutic targets. Repurposed and investigational agents are being studied for use in COVID-19. Although knowledge is rapidly expanding in regard to COVID-19 and there is promise with a few agents, there are no definitely proven effective therapies at this time. Supportive care remains the mainstay of therapy while ongoing clinical trials are being conducted.


Asunto(s)
Ácido Ascórbico/uso terapéutico , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/terapia , Humanos , Inmunización Pasiva , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
19.
MMWR Recomm Rep ; 69(8): 1-24, 2020 08 21.
Artículo en Inglés | MEDLINE | ID: covidwho-727540

RESUMEN

This report updates the 2019-20 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2019;68[No. RR-3]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For each recipient, a licensed and age-appropriate vaccine should be used. Inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV4), and live attenuated influenza vaccine (LAIV4) are expected to be available. Most influenza vaccines available for the 2020-21 season will be quadrivalent, with the exception of MF59-adjuvanted IIV, which is expected to be available in both quadrivalent and trivalent formulations.Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 23, 2019; February 26, 2020; and June 24, 2020. Primary updates to this report include the following two items. First, the composition of 2020-21 U.S. influenza vaccines includes updates to the influenza A(H1N1)pdm09, influenza A(H3N2), and influenza B/Victoria lineage components. Second, recent licensures of two new influenza vaccines, Fluzone High-Dose Quadrivalent and Fluad Quadrivalent, are discussed. Both new vaccines are licensed for persons aged ≥65 years. Additional changes include updated discussion of contraindications and precautions to influenza vaccination and the accompanying Table, updated discussion concerning use of LAIV4 in the setting of influenza antiviral medication use, and updated recommendations concerning vaccination of persons with egg allergy who receive either cell culture-based IIV4 (ccIIV4) or RIV4.The 2020-21 influenza season will coincide with the continued or recurrent circulation of SARS-CoV-2 (the novel coronavirus associated with coronavirus disease 2019 [COVID-19]). Influenza vaccination of persons aged ≥6 months to reduce prevalence of illness caused by influenza will reduce symptoms that might be confused with those of COVID-19. Prevention of and reduction in the severity of influenza illness and reduction of outpatient illnesses, hospitalizations, and intensive care unit admissions through influenza vaccination also could alleviate stress on the U.S. health care system. Guidance for vaccine planning during the pandemic is available at https://www.cdc.gov/vaccines/pandemic-guidance/index.html.This report focuses on recommendations for the use of vaccines for the prevention and control of seasonal influenza during the 2020-21 season in the United States. A brief summary of the recommendations and a link to the most recent Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used within Food and Drug Administration (FDA)-licensed indications. Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information.


Asunto(s)
Vacunas contra la Influenza/uso terapéutico , Gripe Humana/prevención & control , Adolescente , Adulto , Comités Consultivos , Anciano , Centers for Disease Control and Prevention, U.S. , Niño , Preescolar , Femenino , Humanos , Esquemas de Inmunización , Lactante , Subtipo H1N1 del Virus de la Influenza A , Subtipo H3N2 del Virus de la Influenza A , Virus de la Influenza B , Vacunas contra la Influenza/efectos adversos , Gripe Humana/epidemiología , Masculino , Persona de Mediana Edad , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Estaciones del Año , Estados Unidos/epidemiología , Vacunas Atenuadas/uso terapéutico , Adulto Joven
20.
Trials ; 21(1): 734, 2020 Aug 24.
Artículo en Inglés | MEDLINE | ID: covidwho-727295

RESUMEN

OBJECTIVES: Primary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events. STUDY DESIGN: Prospective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible. PARTICIPANTS: Hospitalised, critically ill patients with suspected or confirmed COVID-19. INTERVENTION AND COMPARATOR: Intervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo. MAIN OUTCOME: All-cause mortality up to 28 days after randomization. SEARCH METHODS: Systematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials. RISK OF BIAS ASSESSMENTS: These will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence. STATISTICAL ANALYSES: Trial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms). PROSPERO REGISTRATION NUMBER: CRD42020197242 FULL PROTOCOL: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.


Asunto(s)
Infecciones por Coronavirus/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Corticoesteroides/uso terapéutico , Betacoronavirus , Enfermedad Crítica , Dexametasona/uso terapéutico , Humanos , Hidrocortisona/uso terapéutico , Metilprednisolona/uso terapéutico , Pandemias , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA