title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Participant characteristics at baseline. | ADVERSE EVENTS, DISEASE | Mean ± standard deviation or frequency (%) provided when applicable.All enrolled participants completed all study timepoints, however not all outcome measures could be performed due to disease severity, progression or adverse events (for example, falls with injury interfered with the 2MWT). On completion of the 26-week... | PMC10089314 | |
Primary outcome | Differences between the groups are presented as mean differences along with 95% confidence intervals. There were no treatment-associated differences in quadriceps extension at 30 degrees in Newton meters (Nm) (mean difference [95% CI]: 4.69 Nm [-5.68,11.46]) and 60 degrees (2.31 Nm [-4.38, 6.84]) during the testosteron... | PMC10089314 | ||
Changes in outcome measures across placebo and testosterone arms and the open label extension arm. | Results are presented as raw number, p value and 95% confidence intervals (lower, upper). Bolded results have significant 95% CI. Placebo = placebo phase, when the participants were provided with the placebo (either 0–12 weeks or 14–26 weeks depending on the participant). Testosterone = testosterone phase, when the par... | PMC10089314 | ||
Secondary outcomes | SECONDARY | There were no treatment-associated differences in lean body mass assessed by DXA (mean difference [95% CI]: 0.30 kg [-0.77,1.38]). The remainder of the secondary outcomes showed no treatment-associated differences ( | PMC10089314 | |
Safety blood results across baseline, placebo, testosterone arms and the OLE. | ADVERSE EVENTS | NA = not available and is also utilised when an individual withdrew from the trial. The highlighted numbers are listed as adverse events. The trial has been split into baseline, placebo and testosterone arms. Placebo = placebo phase, when the participants were provided with the placebo (either 0–12 weeks or 14–26 weeks... | PMC10089314 | |
Patient reported outcome questionnaires | Within the RAND-SF-36, there was a difference between testosterone and placebo groups in the domain of emotional wellbeing (mean difference [95% CI]: 6 [1.71:10.29]), with participants scoring higher in this domain (indicating better health status) during the testosterone arm compared to the placebo arm ( | PMC10089314 | ||
Change in IBM-FRS total score across the study period. | The IBM-FRS consists of 10 questions, each of which can be scored 0–4. A score of 40 out of 40 indicates no impairment in function. This graph maps the change in total IBM-FRS score across the study arms. | PMC10089314 | ||
Comparison of the RAND-SF-36 and IBM-FRS testosterone and placebo results. | RAND-SF-36 | PMC10089314 | ||
Adverse events | cramping, pain | ADVERSE EVENTS | A high rate of participant adherence to the study protocol was verified through participant-reported medication and exercise diaries, combined with drug reconciliation processes. The most common adverse events (AEs) during the crossover period were falls and calf swelling, pain or cramping ( | PMC10089314 |
Adverse events dependent on trial arm. | ADVERSE EVENTS | The adverse events for this study are separated into placebo, testosterone and OLE arms. Placebo = placebo phase, when the participants were provided with the placebo (either 0–12 weeks or 14–26 weeks depending on the participant). Testosterone = testosterone phase, when the participans were provided with testosterone ... | PMC10089314 | |
Open label extension study | Two men declined to enter the OLE, leaving 12 participants. The results for the 2MWT, peak torque extension 60 degrees, right grip strength and left grip strength have been provided as graphs ( | PMC10089314 | ||
Results of the OLE study across 6 and 12 months. | SECONDARY | A summary of four of the secondary outcome measures separated into three timepoints—the end of the trial, 6 months and 12 months. The black line in the graphs refers to the average. Ids = participant IDs. | PMC10089314 | |
Post- trial survey | This optional survey was answered by 71% of participants (n = 10) and their partners (n = 10). Of these, 70% of participants and 60% of their partners correctly determined when the participant was on the testosterone arm of the study. From the participant perspective, this was because of perceived changes in libido (n ... | PMC10089314 | ||
Discussion | heterogenous, worsening disability, loss of muscle mass, pain, muscle disease | DISEASE PROGRESSION, ADVERSE EVENTS, EVENT, DISEASE, MUSCLE DISEASE | In this 26-week pilot study comparing the combination of testosterone supplementation and exercise training versus exercise alone, we were unable to detect a significant additional effect of testosterone on muscle strength or physical function in men with IBM over the 12-week intervention period. However, individuals o... | PMC10089314 |
Supporting information | PMC10089314 | |||
CONSORT 2010 checklist: Testosterone treatment combined with exercise to improve muscle strength, physical function and quality of life in men affected by inclusion body myositis: A randomised, double-blind, placebo-controlled, crossover trial. | (PDF)Click here for additional data file.We would like to acknowledge Benjamin Adams & Behnaz Shatahmassebi; as well as the IBM patients who participated in this study, their partners and support networks. | PMC10089314 | ||
References | PMC10089314 | |||
Background | TYPE 2 DIABETES | We assessed the impact of 24 months of treatment with ipragliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on endothelial function in patients with type 2 diabetes as a sub-analysis of the PROTECT study. | PMC10199575 | |
Methods | VASODILATION | In the PROTECT study, patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241 ) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) in a 1:1 ratio. Among the 482 patients in the PROTECT study, flow-mediated vasodilation (FMD) was assessed in 32 patients in th... | PMC10199575 | |
Results | HbA1c levels significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group, but not in the control group. However, there was no significant difference between the changes in HbA1c levels in the two groups (7.4 ± 0.8% vs. 7.0 ± 0.9% in the ipragliflozin group and 7.4 ± 0.... | PMC10199575 | ||
Conclusions | TYPE 2 DIABETES | Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change endothelial function assessed by FMD in the brachial artery. | PMC10199575 | |
Keywords | Registration Number for Clinical Trial: jRCT1071220089 ( | PMC10199575 | ||
Introduction | heart failure, atherosclerosis | ENDOTHELIAL DYSFUNCTION, ATHEROSCLEROSIS, EVENTS, HEART FAILURE, TYPE 2 DIABETES | Sodium glucose cotransporter 2 (SGLT2) inhibitors are oral glucose medicines that lower glucose levels by reducing the renal reabsorption of glucose. Some meta-analyses and large clinical trials have shown that SGLT2 inhibitors reduce cardiovascular events in patients with type 2 diabetes and reduced the rate of hospit... | PMC10199575 |
Methods | PMC10199575 | |||
Study design and patients | TYPE 2 DIABETES | The rationale and design of the PROTECT study (University Hospital Medical Information Network Center: ID000018440) have already been explained [Between September 2015 and June 2018, 488 patients with type 2 diabetes were enrolled, and 482 patients were randomized to receive either standard antihyperglycemic treatment ... | PMC10199575 | |
FMD measurement protocol | artery transducer | REACTIVE HYPEREMIA | After overnight fasting, all experiments were conducted in the morning. All of the patients were kept in the supine position in a calm, dark, air-conditioned room with a constant temperature of 22 ℃–25 ℃ throughout the study. A 23-gauge polyethylene catheter was placed in the left deep antecubital vein to collect blood... | PMC10199575 |
Statistical analysis | REGRESSION | Results are presented as means ± SD. Statistical significance was defined as a probability value < 0.05, and all stated probability values were two-sided. The chi-square test was used to compare categorical variables and an unpaired Student’s t-test was used to compare the mean values of continuous variables between th... | PMC10199575 | |
Results | PMC10199575 | |||
Changes in clinical characteristics after 24 months | In the ipragliflozin group, body mass index was significantly decreased after 24 months (28.4 ± 3.8 vs. 26.7 ± 3.8 kg/m | PMC10199575 | ||
Glycemic control | The baseline HbA1c and fasting plasma glucose levels were comparable between the two groups. The HbA1c level significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group (7.4 ± 0.8% vs. 7.0 ± 0.9%; P < 0.01), but not in the control group (7.4 ± 0.7% vs. 7.3 ± 0.7%; P = ... | PMC10199575 | ||
Endothelial function | VASODILATION | Figure
Changes in estimated percentage change in flow-mediated vasodilation (FMD) in the ipragliflozin group and the control group. The mixed-effects model included treatment, age, sex, and FMD at baseline | PMC10199575 | |
Discussion | TYPE 2 DIABETES | The present study demonstrated that adding ipragliflozin to standard therapy for 24 months in patients with type 2 diabetes did not change endothelial function as measured by FMD in the conduit brachial artery. | PMC10199575 | |
Impact of SGLT2 inhibitors on FMD | TYPE 2 DIABETES | The short-term impacts of SGLT2 inhibitors on the vascular function in patients with type 2 diabetes are controversially reported [ | PMC10199575 | |
Impact of SGLT2 inhibitors on endothelial function | heart failure | EVENTS, HEART FAILURE, TYPE 2 DIABETES | Several clinical trials have shown that SGLT2 inhibitors can prevent cardiovascular events in patients with type 2 diabetes and heart failure [ | PMC10199575 |
Study limitations | TYPE 2 DIABETES | This study has some limitations. First, the number of subjects in the present study, as a sub-analysis of the PROTECT trial, was relatively small. Because FMD was an optional measurement in the PROTECT trial, there was an insufficient sample size for power calculation, and the analysis may have been underpowered. Howev... | PMC10199575 | |
Conclusion | TYPE 2 DIABETES | Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change the endothelial function assessed by FMD in the brachial artery. | PMC10199575 | |
Acknowledgements | Shinichi, Kondo, Tadaaki, Hirotsugu | TAKAHARA, HEART, CROSS, SHIGA | The authors thank all the participants, investigators, board members, and medical staff involved in the RPOTECT study. The authors are also grateful to the members of the Data and Safety Monitoring Board: Munehide Matsuhisa, MD, PhD (Tokushima University Graduate School, Tokushima, Japan), Junya Ako, MD, PhD, (Kitasato... | PMC10199575 |
Authors contributions | HT | YH and SK drafted the manuscript and conceived the study. TI performed statistical analyses. SK, YH, KE, KF, HT, and KM measured the FMD. AT and KN critically revised the manuscript for important intellectual content. All the authors contributed to the manuscript and approved the submitted version. All authors read and... | PMC10199575 | |
Funding | This study was funded by Astellas Pharma Inc. Japan, and Prof. Koichi Node received the funding. The funding agency of the trial had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript. | PMC10199575 | ||
Availability of data and materials | The data are available upon reasonable request from researchers who submit a detailed proposal outlining their intended use of the data and after approval by the principal investigators and steering committee of the PROTECT study. Inquiries must be addressed to the corresponding author (or the study secretariat: substu... | PMC10199575 | ||
Declarations | PMC10199575 | |||
Ethics approval and consent to participate | The study protocol for this sub-analysis was approved by the Ethics Committee of Saga University Hospital (2022-09-02) and registered (jRCT1071220089). All the individuals provided written informed consent to participate in the study. All methods were performed in accordance with the Declaration of Helsinki and relevan... | PMC10199575 | ||
Consent for publication | All authors have read and approved the submission of the manuscript. | PMC10199575 | ||
Competing interests | Competing interestsYH received honoraria
from Astellas, AstraZeneca, MSD, Boehringer Ingelheim, Takeda, Bayer, Novo
Nordisk, Fuji, Mochida, Eli Lilly, Teijin Pharma, Daiichi Sankyo, Otsuka, Kowa,
Novartis, and Mitsubishi Tanabe and a research grant from Kao. TI received
lecture fees from JCR Pharmaceuticals and Kyowa K... | PMC10199575 | ||
References | PMC10199575 | |||
Background | menopausal syndrome, senile dementia, osteoporosis, senile diseases | MENOPAUSAL SYNDROME, SENILE DEMENTIA, OSTEOPOROSIS | Edited by: Andrew Scott LaJoie, University of Louisville, United StatesReviewed by: Seyedmohammad Mirhosseini, Shahroud University of Medical Sciences, Iran; Kristi King, University of Louisville, United StatesThis article was submitted to Public Health Education and Promotion, a section of the journal Frontiers in Pub... | PMC10060660 |
Objectives | menopausal syndrome | MENOPAUSAL SYNDROME | This study aimed to evaluate the effect of multidisciplinary health education based on lifestyle medicine on menopausal syndrome and lifestyle behaviors of menopausal women. | PMC10060660 |
Methods | The study was conducted in several hospitals in Chongqing, China. The two groups were from different hospitals with similar medical levels in order to reduce information contamination. It was designed as a clinical controlled trial in which the intervention group ( | PMC10060660 | ||
Results | menopausal syndrome | MENOPAUSAL SYNDROME | Post intervention testing indicated that menopausal syndrome of participants was significantly improved in the intervention group compared to the control group ( | PMC10060660 |
Conclusions | menopausal syndrome | MENOPAUSAL SYNDROME | The multidisciplinary health education based on lifestyle medicine was effective in improving the menopausal syndrome and healthy lifestyle behaviors of menopausal women. Studies with extended observation period and larger sample size are in need to evaluate the long-term scale-up effects of the multidisciplinary healt... | PMC10060660 |
1. Introduction | insomnia, chronic disease, depression, menopausal syndrome, osteoporosis, arthralgia | DISEASE, SENILE DEMENTIA, MENOPAUSAL SYNDROME, OSTEOPOROSIS, CHRONIC DISEASE | Women typically enter menopause gradually at the age of 40 and continue until the age of 60. Due to declining ovarian function and falling estrogen levels, women in this period may experience menopausal syndrome which may manifest as hot flashes, arthralgia, insomnia, depression and so on (Despite many complaints that ... | PMC10060660 |
2. Methods | PMC10060660 | |||
2.1. Study setting and participants | menopausal syndrome | MENOPAUSAL SYNDROME, DISEASES, OSTEOPOROSIS | The study was conducted in six hospitals in Chongqing, China from August 2021 to August 2022. Participants were from different hospitals with Grade-A Tertiary Hospital in order to reduce information contamination. Located in southwestern China, Chongqing is known as a “miniature of China” because its urban-rural distri... | PMC10060660 |
2.2. Sample size calculation | Sample size for the study was decided by comparing the KMI before and after the MHELM among participants in polit, using the formula | PMC10060660 | ||
2.3. Intervention | This study was designed as a clinical controlled trial in which intervention group and control group were matched for age, age at menarche, menopausal symptoms and drug use status at enrollment. The criterion of matching referred that no statistical significance was detected in the difference analyses of baseline indic... | PMC10060660 | ||
2.3.1. Multidisciplinary health education based on lifestyle medicine | MHELM comprised of three parts: 1-day Multidisciplinary Health Education Sessions offline, 7-week Group Healthy Lifestyle Management online, and half-day Patient Symposium offline. | PMC10060660 | ||
2.3.1.1. One-day multidisciplinary health education sessions | hypoestrogenism, pelvic muscle, osteoporosis | OSTEOPOROSIS | The sessions were provided by a multidisciplinary team (MDT) consisting of six experts under the professional background of gynecologic endocrinology, sports medicine, nutrition, music therapy, psychology, pharmacy, and osteoporosis. The sessions focused on menopausal symptom management, encouragement of physical activ... | PMC10060660 |
2.3.1.2. Seven-week group healthy lifestyle management | Seven-week Group Healthy Lifestyle Management following the 1-day multidisciplinary health education sessions were provided by professionals through WeChat. The content of the online group intervention included: reading, audio and video products of science popularization on the knowledge of menopausal health, reasonabl... | PMC10060660 | ||
2.3.1.3. Half-day patient symposium | After completing the 7-week Group Healthy Lifestyle Management, patients revisited the hospital for the Half-day Patient Symposium. In the symposium, experts reemphasized the importance of MHELM, and participants were encouraged to share their feelings and experience on MHELM. Participants who completed the whole proce... | PMC10060660 | ||
2.3.2. Control group | Participants in the control group filled out the pre- and post- questionnaires with a 2-month interval of follow-up, and in between they only received routine outpatient health guidance from perimenopausal physicians on the knowledge of perimenopausal symptoms and healthy lifestyle at enrollment. | PMC10060660 | ||
2.3.3. Ethical considerations | All the participants voluntarily signed the informed consent before the study. This study was approved by Institutional Review Board of the Third Affiliated Hospital of Chongqing Medical University (Number: 202112) and has been registered in Chinese Clinical Trial Registry (Registration number: ChiCTR2100049969). | PMC10060660 | ||
2.4. Outcomes measurement | menopausal syndrome | MENOPAUSAL SYNDROME | All participants filled out a pre-testing questionnaire at baseline and a post-testing questionnaire after 2 months. The primary outcomes included changes of women's menopausal syndrome and lifestyle behaviors such as physical activity and dietary status. Participants' feedback of MHELM group were interviewed as the se... | PMC10060660 |
2.4.1. mKMI for menopausal syndrome | menopausal syndrome, Menopausal syndrome | MENOPAUSAL SYNDROME, MENOPAUSAL SYNDROME | Menopausal syndrome was evaluated by the mKMI, which was a widely used scale to measure the presence and severity of menopausal syndrome. mKMI consisted of 13 items assessing the situation of women over the past week. The items included somatic, psychological and urogenital symptoms. The severity of each symptom was ra... | PMC10060660 |
2.4.2. IPAQ for physical activities | IPAQ long form was applied to assess physical activity (PA) of the participants. It consisted of 27 items which reflected on the consumed time on walking and engaging in moderate-intensity plus vigorous-intensity activities in terms of different domains in the past week: (1) occupational PA; (2) traffic PA; (3) housewo... | PMC10060660 | ||
2.4.3. Dietary habits questionnaire | Dietary status of the participants was assessed by the Dietary Habits Questionnaire, which was adapted from a questionnaire developed by the National High-tech Health Industry Working Committee of China and took account of dietary characteristics of menopausal women ( | PMC10060660 | ||
2.4.4. Participants' feedback in the intervention group | Feedback from the participants in MHELM, including feelings, experience and suggestions, were collected through focus group discussions (FGDs) during the Half-day Patient Symposium. The process of discussions were assessed by perimenopausal physicians and recorded by two other professionals. Thematic analysis method wa... | PMC10060660 | ||
2.5. Statistical analysis | Continuous variables that were normally distributed were presented with mean ± standard deviation, and compared using Paired | PMC10060660 | ||
3. Results | PMC10060660 | |||
3.2. Comparison of women's menopausal syndrome, lifestyle behavior | Comparisons of mKMI, IPAQ and dietary status within and between groups were listed in Comparison of mKMI, IPAQ and dietary status within and between groups.PA, physical activity. | PMC10060660 | ||
3.3. Changes in women's menopausal syndrome, lifestyle behavior according different drug use status | Comparisons of the changes on mKMI, IPAQ and dietary status were listed in Changes of KMI, IPAQ and dietary status within and between groups according different drug use status.The value of comparison within and between groups is the change value of the test (the post-test value minus the pre-test value); PA, physical ... | PMC10060660 | ||
3.4. The participants' feedback in the intervention group | The women's feedback after participating MHPEI were summarized into the following four themes including relief of menopausal symptoms, awareness and behavior of menopausal health management, relief of negative emotions and improvement of menopausal cognition. Highlighting statements were shown in Participants' feedback... | PMC10060660 | ||
4. Discussion | menopausal syndrome | CHRONIC DISEASES, ESTROGEN DEFICIENCY, MENOPAUSAL SYNDROME, DISEASES, OSTEOPOROSIS | The present study took the lead in exploring the effects of multidisciplinary health education intervention based on lifestyle medicine on menopausal women in China. The current study revealed that MHELM helped the women to feel relief from troublesome menopausal syndrome, improve healthy lifestyle behaviors and enhanc... | PMC10060660 |
5. Conclusion | menopausal syndrome | MENOPAUSAL SYNDROME | This study showed that multidisciplinary health education based on lifestyle medicine was effective in improving the menopausal syndrome and healthy lifestyle behaviors of menopausal women. The MHELM may lighten the design and implementation of similar interventions in future studies. Studies with extended Observation ... | PMC10060660 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10060660 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the Institutional Review Board of the Third Affiliated Hospital of Chongqing Medical University (202112). The patients/participants provided their written informed consent to participate in this study. | PMC10060660 | ||
Author contributions | YML participated in field investigation, data collection, and drafting of the manuscript. HYH participated in the design of the study and field investigation and data collection. JXW, YFC, CYW, XYL, and AQD participated in field investigation and data collection. YL participated data analysis. YF, XX, JH, MZ, MFZ, and ... | PMC10060660 | ||
Abbreviations | MHT, Menopausal hormone therapy; MHELM, multidisciplinary health education based on lifestyle medicine; mKMI, modified Kupperman Menopause Index; MDT, multidisciplinary team; IPAQ, International Physical Activity Questionnaire; PA, physical activity. | PMC10060660 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10060660 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10060660 | ||
References | PMC10060660 | |||
Subject terms | Adenotonsillectomy, pain | Adenotonsillectomy is the most common daytime surgery performed on children. Anesthesiologists must select the optimal combination of drugs to ensure effective anesthesia effect and prompt recovery in children. The optimal induction dose of ciprofol in children is unclear. In this study, we aim to investigate the effec... | PMC10721598 | |
Introduction | Adenotonsillectomy, respiratory depression, pain | RESPIRATORY DEPRESSION | Anesthesiologists face greater challenges when administering anesthesia to children during daytime surgeries. It requires careful selection of medications and their optimal combination to ensure effective anesthesia and prompt recovery of the child.Adenotonsillectomy is the most common daytime surgery for children. Ane... | PMC10721598 |
Materials and methods | comorbid inherited metabolic diseases, allergies, traumatic, trauma | ALLERGIES | This study was approved by the Medical Ethics Committee of Hunan Children’s Hospital (HCHLL-2022–079) and registered with the Chinese Clinical Trial Registry (Registration number: ChiCTR2200063144, Date of Registration: 31/08/2022). All experiments were conducted in compliance with the Declaration of Helsinki and relev... | PMC10721598 |
Anesthesia process | pain | SECONDARY | Children were admitted to the operating room with a peripheral intravenous catheter. Their heart rate (HR), mean arterial pressure (MAP), oxygen saturation, and bispectral index (BIS) were monitored. The selected dose of ciprofol was injected during anesthesia induction, and the injection took 30 s. Children were asked... | PMC10721598 |
Statistical analysis | The sample size was calculated by 90% power of the study. Fifty children per group were required to determine a minimal allowable difference of 15% in clinically unacceptable intubation conditions between groups by an alpha error of 0.05. Comparisons between groups for intubation conditions in children were performed u... | PMC10721598 | ||
Discussion | Adenotonsillectomy, fasciculation, pain, agitation, hyperexcitability, fasciculations | ADVERSE EFFECTS, CORTEX | Anesthesia for day surgery in pediatric patients is more challenging than in adults due to physiological peculiarities. Adenotonsillectomy is a frequently performed pediatric day surgery procedure that often necessitates endotracheal intubation to ensure the child’s airway secured. Neuromuscular blockers (NMBs) are typ... | PMC10721598 |
Acknowledgements | We would like to thank all staff from the Anesthesia Department of Hunan Children's Hospital for their help in collecting the data. | PMC10721598 | ||
Author contributions | D.P.: Conceptualization, Methodology, Formal analysis, Writing-Original Draft. L.Z.: Resources, Data Curation. T.X., L.W.: Investigation. L.W., S.W.: Formal analysis, Validation. Z.D., S.Q.: Supervision, Project administration. All authors read and approved the final submitted version. | PMC10721598 | ||
Funding | The research was supported by the Scientific Research Fund of Hunan Medical Association (HNA202101020) and the Scientific Research Project of Hunan Provincial Health Commission (D202304118023). | PMC10721598 | ||
Data availability | The data that support the findings of this study are available from the corresponding author Shuangquan Qu upon reasonable request. | PMC10721598 | ||
Competing interests | The authors declare no competing interests. | PMC10721598 | ||
References | PMC10721598 | |||
Abstract | P. | P. J. and W. H. K. S. contributed equally to this work.
All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. | PMC10640773 | |
Background | coronavirus disease 2019 | CORONAVIRUS DISEASE 2019 | Uncertainty over the therapeutic benefit of parenteral remdesivir in coronavirus disease 2019 (COVID-19) has resulted in varying treatment guidelines. | PMC10640773 |
Methods | ASYMPTOMATIC COVID-19, SEVERE ACUTE RESPIRATORY SYNDROME, CORONAVIRUS | In a multicenter open-label, controlled, adaptive, pharmacometric platform trial, low-risk adult patients with early symptomatic COVID-19 were randomized to 1 of 8 treatment arms including intravenous remdesivir (200 mg followed by 100 mg daily for 5 days) or no study drug. The primary outcome was the rate of severe ac... | PMC10640773 | |
Results | The 2 study arms enrolled 131 patients (remdesivir n = 67, no study drug n = 64) and estimated viral clearance rates from a median of 18 swab samples per patient (a total of 2356 quantitative polymerase chain reactions). Under the linear model, compared with the contemporaneous control arm (no study drug), remdesivir a... | PMC10640773 | ||
Conclusions | coronavirus disease 2019 | ASYMPTOMATIC COVID-19, CORONAVIRUS DISEASE 2019 | Parenteral remdesivir accelerates viral clearance in early symptomatic COVID-19. Pharmacometric assessment of therapeutics using the method described can determine in vivo clinical antiviral efficacy rapidly and efficiently.In early symptomatic COVID-19, intravenous remdesivir accelerated viral clearance compared with ... | PMC10640773 |
METHODS | ASYMPTOMATIC COVID-19 | PLATCOV is an ongoing phase 2 open-label, randomized, controlled, adaptive, pharmacometric platform trial (ClinicalTrials.gov identifier NCT05041907). It provides a standardized quantitative comparative method for in vivo assessment of potential antiviral treatments in low-risk adults with early symptomatic COVID-19. T... | PMC10640773 | |
Randomization and Interventions | Randomization was performed via a centralized web application designed by MORU software engineers using RShiny, hosted on a MORU webserver. The control arm comprised a minimum proportion of 20% of patients with uniform randomization ratios applied across the treatment arms. All patients received standard symptomatic tr... | PMC10640773 | ||
Participants and Procedures | chronic illness, hypersensitivity, comorbidity | ASYMPTOMATIC COVID-19, CHRONIC ILLNESS, HYPERSENSITIVITY | Previously healthy adults aged between 18 and 50 years were eligible for enrollment if they had early symptomatic COVID-19 (i.e., reported symptoms for ≤4 days), oxygen saturation ≥96%, were unimpeded in activities of daily living, and gave fully informed consent. SARS-CoV-2 positivity was defined either as a nasal lat... | PMC10640773 |
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