SUMMARYBackgroundWe evaluated the use of baricitinib, a Janus kinase (JAK) 1/2 inhibitor, for the... more SUMMARYBackgroundWe evaluated the use of baricitinib, a Janus kinase (JAK) 1/2 inhibitor, for the treatment of patients admitted to hospital because of COVID-19.MethodsThis randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner (baricitinib group). The primary outcome was 28-day mortality assessed in the intention-to-treat population. A meta-analysis was conducted that included the results from the RECOVERY trial and all previous randomised controlled trials of baricitinib or other JAK inhibitor in patients hospitalised with COVID-19. The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).FindingsBetwe...
Background: Specific mutations in epidermal growth factor receptor ( EGFR ) are predictive for re... more Background: Specific mutations in epidermal growth factor receptor ( EGFR ) are predictive for response to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients. However, most patients acquire resistance to the first generation-TKIs and in about half of these patients the resistance is driven by EGFR T790M mutation. Recently, third generation-TKIs are shown to be effective in patients harbouring this mutation. Although re-biopsy of tumour tissue is regarded as a gold standard in recurrent and NSCLC patients, the procedure can be challenging and hazardous, and tumour heterogeneity between primary and metastatic sites can be a limiting factor for accurate mutational analysis. In recent years, liquid biopsy for the detection of circulating tumour DNA (ctDNA) has been used for EGFR mutation analysis using qualitative PCR assays. Since the detection rate of qPCR for T790M is only 30-50%, droplet digital PCR (ddPCR) has emerged as a more reliable assay for...
Background Early symptoms of dementia may not be apparent and are sometimes even concealed during... more Background Early symptoms of dementia may not be apparent and are sometimes even concealed during short office visits initiated for other complaints. The aim of the study is to find out if the combined use of VF/CDT, VF/BNT, or CDT/BNT could improve the accuracy of detecting mild NCD in an outpatient setting, compared with either test used alone. Participants Community-dwelling older adults, attending the outpatient Geriatrics Clinic at Ain Shams University hospitals between June 1, 2017 and January 31, 2018. All participants received a comprehensive geriatric assessment (CGA) which included the mini-mental state examination test. Participants with a score of less than 24 and fulfil DSM5 criteria for mild neurocognitive disorder (NCD) are considered cognitively impaired otherwise are considered normal. Then participants were further examined by the Arabic versions of CDT, BNT, and VF animal category. Results We recruited 143 male and female participants mean age 67.17 ± 5.41, female...
SUMMARYBackgroundREGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab... more SUMMARYBackgroundREGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab) that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike protein. We aimed to evaluate the efficacy and safety of REGEN-COV in patients admitted to hospital with COVID-19.MethodsIn this randomised, controlled, open-label platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus a single dose of REGEN-COV 8g (casirivimab 4g and imdevimab 4g) by intravenous infusion (REGEN-COV group). The primary outcome was 28-day mortality assessed first among patients without detectable antibodies to SARS-CoV-2 at randomisation (seronegative) and then in the overall population. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).FindingsBetween 18...
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunom... more Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65•3 years (SD 15•7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0•97, 95% CI 0•87-1•07; p=0•50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1•04, 95% CI 0•98-1•10; p=0•19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0•95, 95% CI 0•87-1•03; p=0•24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication.
Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admit... more Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg-800 mg (depending on weight) given intravenously. A second dose could be given 12-24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).
Background Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 a... more Background Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
Background: Little is known regarding the standardized neuropsychological tests available in Arab... more Background: Little is known regarding the standardized neuropsychological tests available in Arabic. The aim is to determine the diagnostic performance and the best cutoff value for the clock drawing test (CDT), animal category test of semantic verbal fluency (VF), and the short form of the Boston Naming Test (BNT) in identifying patients with mild and major neurocognitive disorders among community-dwelling educated Egyptian older adults using Arabic versions of those tests. Community-dwelling educated male and female older adults aged 60 years or older. Successive patients were attending the outpatient geriatrics clinic at the Ain Shams University Hospital during a 12month study period from January to December 2016. The study was approved by the ethics committee of the
Cognitive and behavioral neurology : official journal of the Society for Behavioral and Cognitive Neurology, 2017
Normative data on cognitive performance for the Omani population are scarce. In this study, we te... more Normative data on cognitive performance for the Omani population are scarce. In this study, we tested a sample of older (≥50 years) community-dwelling Omanis on the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery-Arabic version (CERAD-ArNB). We analyzed the participants' cognitive performance and how it was affected by their sex, age, and level of education. We enrolled 150 older Arabic-speaking Omanis from March 2014 to June 2015. Most of the participants were visitors to patients admitted to a tertiary referral center in the Sultanate of Oman. All participants underwent screening to ensure normal cognitive function before taking the CERAD-ArNB. We used multiple regression analysis and stratification according to demographic variables to illustrate the normative data. A total of 125 participants, 65 men (52%) and 60 women (48%), met the inclusion criteria and completed the testing. Multiple regression and univariate analyses showed that...
International journal of nursing studies, Jan 28, 2017
Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited... more Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited by the need for a valid/reliable translation of a standardized delirium instrument such as the Confusion Assessment Method for the ICU (CAM-ICU). To determine the validity and reliability of the Arabic version of the CAM-ICU. A prospective cohort study design was used to conduct the current study. Data collection took place in Geriatric, Emergency and Surgical intensive care units. Fifty-eight adult patients met the inclusion criteria and participated in the study. Among the participants 22(38%) patients were on mechanical ventilation. After translating the CAM-ICU into Arabic language, the Arabic CAM-ICU was administered by two well-trained critical care nurses and compared with reference standard assessments by delirium experts using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM -IV-TR), along with assessment of severity of illness using Se...
SUMMARYBackgroundWe evaluated the use of baricitinib, a Janus kinase (JAK) 1/2 inhibitor, for the... more SUMMARYBackgroundWe evaluated the use of baricitinib, a Janus kinase (JAK) 1/2 inhibitor, for the treatment of patients admitted to hospital because of COVID-19.MethodsThis randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus baricitinib 4 mg once daily by mouth for 10 days or until discharge if sooner (baricitinib group). The primary outcome was 28-day mortality assessed in the intention-to-treat population. A meta-analysis was conducted that included the results from the RECOVERY trial and all previous randomised controlled trials of baricitinib or other JAK inhibitor in patients hospitalised with COVID-19. The RECOVERY trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).FindingsBetwe...
Background: Specific mutations in epidermal growth factor receptor ( EGFR ) are predictive for re... more Background: Specific mutations in epidermal growth factor receptor ( EGFR ) are predictive for response to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients. However, most patients acquire resistance to the first generation-TKIs and in about half of these patients the resistance is driven by EGFR T790M mutation. Recently, third generation-TKIs are shown to be effective in patients harbouring this mutation. Although re-biopsy of tumour tissue is regarded as a gold standard in recurrent and NSCLC patients, the procedure can be challenging and hazardous, and tumour heterogeneity between primary and metastatic sites can be a limiting factor for accurate mutational analysis. In recent years, liquid biopsy for the detection of circulating tumour DNA (ctDNA) has been used for EGFR mutation analysis using qualitative PCR assays. Since the detection rate of qPCR for T790M is only 30-50%, droplet digital PCR (ddPCR) has emerged as a more reliable assay for...
Background Early symptoms of dementia may not be apparent and are sometimes even concealed during... more Background Early symptoms of dementia may not be apparent and are sometimes even concealed during short office visits initiated for other complaints. The aim of the study is to find out if the combined use of VF/CDT, VF/BNT, or CDT/BNT could improve the accuracy of detecting mild NCD in an outpatient setting, compared with either test used alone. Participants Community-dwelling older adults, attending the outpatient Geriatrics Clinic at Ain Shams University hospitals between June 1, 2017 and January 31, 2018. All participants received a comprehensive geriatric assessment (CGA) which included the mini-mental state examination test. Participants with a score of less than 24 and fulfil DSM5 criteria for mild neurocognitive disorder (NCD) are considered cognitively impaired otherwise are considered normal. Then participants were further examined by the Arabic versions of CDT, BNT, and VF animal category. Results We recruited 143 male and female participants mean age 67.17 ± 5.41, female...
SUMMARYBackgroundREGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab... more SUMMARYBackgroundREGEN-COV is a combination of 2 monoclonal antibodies (casirivimab and imdevimab) that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike protein. We aimed to evaluate the efficacy and safety of REGEN-COV in patients admitted to hospital with COVID-19.MethodsIn this randomised, controlled, open-label platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting patients were randomly allocated (1:1) to either usual standard of care alone (usual care group) or usual care plus a single dose of REGEN-COV 8g (casirivimab 4g and imdevimab 4g) by intravenous infusion (REGEN-COV group). The primary outcome was 28-day mortality assessed first among patients without detectable antibodies to SARS-CoV-2 at randomisation (seronegative) and then in the overall population. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).FindingsBetween 18...
Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunom... more Background Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19. Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospital with COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatment groups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants and local study staff were not masked to the allocated treatment, but all others involved in the trial were masked to the outcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) were eligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was 65•3 years (SD 15•7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomly allocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall, 561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days (rate ratio 0•97, 95% CI 0•87-1•07; p=0•50). No significant difference was seen in duration of hospital stay (median 10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days (rate ratio 1•04, 95% CI 0•98-1•10; p=0•19). Among those not on invasive mechanical ventilation at baseline, no significant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (risk ratio 0•95, 95% CI 0•87-1•03; p=0•24). Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or other prespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restricted to patients in whom there is a clear antimicrobial indication.
Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admit... more Background In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg-800 mg (depending on weight) given intravenously. A second dose could be given 12-24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936).
Background Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 a... more Background Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
Background: Little is known regarding the standardized neuropsychological tests available in Arab... more Background: Little is known regarding the standardized neuropsychological tests available in Arabic. The aim is to determine the diagnostic performance and the best cutoff value for the clock drawing test (CDT), animal category test of semantic verbal fluency (VF), and the short form of the Boston Naming Test (BNT) in identifying patients with mild and major neurocognitive disorders among community-dwelling educated Egyptian older adults using Arabic versions of those tests. Community-dwelling educated male and female older adults aged 60 years or older. Successive patients were attending the outpatient geriatrics clinic at the Ain Shams University Hospital during a 12month study period from January to December 2016. The study was approved by the ethics committee of the
Cognitive and behavioral neurology : official journal of the Society for Behavioral and Cognitive Neurology, 2017
Normative data on cognitive performance for the Omani population are scarce. In this study, we te... more Normative data on cognitive performance for the Omani population are scarce. In this study, we tested a sample of older (≥50 years) community-dwelling Omanis on the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery-Arabic version (CERAD-ArNB). We analyzed the participants' cognitive performance and how it was affected by their sex, age, and level of education. We enrolled 150 older Arabic-speaking Omanis from March 2014 to June 2015. Most of the participants were visitors to patients admitted to a tertiary referral center in the Sultanate of Oman. All participants underwent screening to ensure normal cognitive function before taking the CERAD-ArNB. We used multiple regression analysis and stratification according to demographic variables to illustrate the normative data. A total of 125 participants, 65 men (52%) and 60 women (48%), met the inclusion criteria and completed the testing. Multiple regression and univariate analyses showed that...
International journal of nursing studies, Jan 28, 2017
Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited... more Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited by the need for a valid/reliable translation of a standardized delirium instrument such as the Confusion Assessment Method for the ICU (CAM-ICU). To determine the validity and reliability of the Arabic version of the CAM-ICU. A prospective cohort study design was used to conduct the current study. Data collection took place in Geriatric, Emergency and Surgical intensive care units. Fifty-eight adult patients met the inclusion criteria and participated in the study. Among the participants 22(38%) patients were on mechanical ventilation. After translating the CAM-ICU into Arabic language, the Arabic CAM-ICU was administered by two well-trained critical care nurses and compared with reference standard assessments by delirium experts using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM -IV-TR), along with assessment of severity of illness using Se...
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Papers by mohamed elokl