scholarly journals Effect of mulmina mango as an adjunct to standard of care treatment on COVID-19 positive subjects undergoing treatment for COVID-19 in hospital quarantine (Dedicated Covid Health Centre)

2022 ◽  
Vol 8 (4) ◽  
pp. 291-297
Author(s):  
M.S. Madhu ◽  
S.M. Ahmed ◽  
Raghavendra. K.V.
Keyword(s):  
Health Centre ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Family Welfare ◽  
Significant Finding ◽  
Symptom Scale ◽  
Care Treatment ◽  
Informed Consent Form ◽  
Number Of Patients ◽  
Standard Of Care Treatment

There are no approved drugs to treat COVID-19, and the vaccine is likely to be ready by early 2021. Many clinical studies are ongoing around the globe to find a cure or prevention of the disease. The objective of the proposed study is to determine the efficacy and safety profile of Mulmina Mango as an adjunct to standard of care treatment on COVID-19 positive subjects undergoing treatment for COVID-19 in Hospital Quarantine. Settings and Design: The enrolled subjects were randomized into either of the two treatment arms in the ratio of 1:1. The freshly diagnosed (24-48 hrs.) COVID-19 positive Male or Female is aged 20 to 65 years (both inclusive) hospitalized patients were approached and checked for their eligibility. They were recruited after signing the written informed consent form. The number of patients included in the study is 48. In efficacy, both the treatment arms and the reduction in clinical symptom scale value and ordinal scale value are seen on day 7. On the ordinal scale, 41.7% of subjects in Treatment arm A showed a reduction of 2 points on the day, and 16.7% of subjects show 2 points reduction in Treatment arm B. In Safety results, there was no clinically significant finding in safety parameters in Treatment arm B. Mulmina Mango showed encouraging results concerning RTPCR, CRP, Dopamine, IgG, CD4, and CD8 parameters. The properties of Mulmina Mango are highlighted below, along with the parameters for each property. Mulmina Mango, COVID-19, Treatment Arm A, Treatment Arm B, MoHFW (Ministry of Health and Family Welfare)

scholarly journals Remdesivir versus Standard-of-Care for Severe Coronavirus Disease 2019 Infection: An Analysis of 28-Day Mortality

2021 ◽  
Author(s):  
Susan A Olender ◽  
Theresa L Walunas ◽  
Esteban Martinez ◽  
Katherine K Perez ◽  
Antonella Castagna ◽  
...  
Keyword(s):  
Standard Of Care ◽  
Supplemental Oxygen ◽  
Hospitalized Patients ◽  
Ordinal Scale ◽  
Open Label ◽  
Open Label Study ◽  
Clinical Recovery ◽  
Care Treatment ◽  
All Cause Mortality ◽  
Standard Of Care Treatment

Abstract Background Remdesivir is FDA approved for the treatment of hospitalized patients with COVID-19 and has been shown to shorten time to recovery and improve clinical outcomes in randomized trials. Methods This was the final day 28 comparative analysis of data from a phase 3, randomized, open-label study comparing 2 remdesivir regimens (5 vs 10 days, combined for this analysis [remdesivir cohort]) and a real-world retrospective longitudinal cohort study of patients receiving standard-of-care treatment (non-remdesivir cohort). Eligible patients, aged ≥18 years, had confirmed SARSCoV-2, oxygen saturation ≤94% on room air or required supplemental oxygen, with pulmonary infiltrates. Propensity score matching (up to 1:10 ratio) was used to ensure comparable populations. We assessed day 14 clinical recovery (determined using a 7-point ordinal scale) and day 28 all-cause mortality (coprimary endpoints). Results Altogether, 368 (remdesivir) and 1399 (non-remdesivir) patients were included in the matched analysis. The day 14 clinical recovery rate was significantly higher among the remdesivir versus the non-remdesivir cohort (65.2% vs 57.1%; OR 1.49, 95% CI 1.16–1.90; P = .002). The day 28 mortality rate was significantly lower in the remdesivir cohort versus the non-remdesivir cohort (12.0% vs 16.2%; OR 0.67, 95% CI 0.47–0.95; P = .03). Conclusions Remdesivir was associated with significantly higher rates of day 14 clinical recovery, and lower day 28 mortality, compared with standard-of-care treatment in hospitalized patients with COVID-19. Collectively, these data support the use of remdesivir to improve clinical recovery and decrease mortality from SARS-CoV-2 infection.

scholarly journals Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care

2020 ◽  
Author(s):  
Susan A Olender ◽  
Katherine K Perez ◽  
Alan S Go ◽  
Bindu Balani ◽  
Eboni G Price-Haywood ◽  
...  
Keyword(s):  
Retrospective Cohort ◽  
Clinical Status ◽  
Antiviral Agent ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Open Label ◽  
Phase 3 ◽  
Inverse Probability ◽  
Care Treatment ◽  
Standard Of Care Treatment

Abstract Background We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard of care. Methods GS-US-540–5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivir-cohort). GS-US-540–5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality. Results After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivir- and non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34–3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22–.68, P = .001). Conclusions In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19. Clinical Trials Registration NCT04292899 and EUPAS34303.

scholarly journals Sitagliptin treatment at the time of hospitalization was associated with reduced mortality in patients with Type 2 Diabetes and COVID-19: a multicenter case-control retrospective observational study

2020 ◽  
Author(s):  
Sebastiano Bruno Solerte ◽  
Francesca D’Addio ◽  
Roberto Trevisan ◽  
Elisabetta Lovati ◽  
Antonio Rossi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Standard Of Care ◽  
Case Control ◽  
Retrospective Observational Study ◽  
Ordinal Scale ◽  
Care Treatment ◽  
Standard Of Care Treatment

<b>Background</b>. Poor outcomes have been reported in patients with type 2 diabetes and coronavirus disease 2019 (COVID-19), thus it is mandatory to explore novel therapeutic approaches for this population. <h2>Methods. In a multicenter case-control retrospective observational study, sitagliptin, an oral and highly selective DPP-4 inhibitor, was added to standard-of-care (e.g.; insulin administration) at the time of hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19. Every center also recruited at 1:1 ratio untreated controls matched for age and gender. All patients had pneumonia and exhibited oxygen saturation lower than 95% when breathing ambient air, or were receiving oxygen support. The primary endpoints were discharge from the hospital/death and improvement of clinical outcomes, defined as an increase in at least two points on a seven-category modified ordinal scale. Data were collected retrospectively from patients receiving sitagliptin from March 1 through April 30, 2020. </h2> <h2>Results. Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted in Northern Italy hospitals included in this study, 169 were on sitagliptin, while 169 were on standard-of-care. Treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs. 37% of deceased patients; HR=0.44, 95% CI: 0.29-0.66, p=0.0001), with an improvement in clinical outcomes (60% vs. 38% of improved patients, p=0.0001) and with a greater number of hospital discharges (120 vs. 89 of discharged patients, p=0.0008), compared to patients receiving standard-of-care respectively. </h2> <h2>Conclusions. In this multicenter case-control retrospective observational study of patients with type 2 diabetes admitted to the hospital for COVID-19, sitagliptin treatment at the time of hospitalization was associated with reduced mortality and improved clinical outcomes as compared to standard-of-care treatment. The effects of sitagliptin in patients with type 2 diabetes and COVID-19 should be confirmed in an ongoing randomized, placebo-controlled trial. </h2>

scholarly journals Sitagliptin treatment at the time of hospitalization was associated with reduced mortality in patients with Type 2 Diabetes and COVID-19: a multicenter case-control retrospective observational study

2020 ◽  
Author(s):  
Sebastiano Bruno Solerte ◽  
Francesca D’Addio ◽  
Roberto Trevisan ◽  
Elisabetta Lovati ◽  
Antonio Rossi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Clinical Outcomes ◽  
Standard Of Care ◽  
Case Control ◽  
Retrospective Observational Study ◽  
Ordinal Scale ◽  
Care Treatment ◽  
Standard Of Care Treatment

<b>Background</b>. Poor outcomes have been reported in patients with type 2 diabetes and coronavirus disease 2019 (COVID-19), thus it is mandatory to explore novel therapeutic approaches for this population. <h2>Methods. In a multicenter case-control retrospective observational study, sitagliptin, an oral and highly selective DPP-4 inhibitor, was added to standard-of-care (e.g.; insulin administration) at the time of hospitalization in patients with type 2 diabetes who were hospitalized with COVID-19. Every center also recruited at 1:1 ratio untreated controls matched for age and gender. All patients had pneumonia and exhibited oxygen saturation lower than 95% when breathing ambient air, or were receiving oxygen support. The primary endpoints were discharge from the hospital/death and improvement of clinical outcomes, defined as an increase in at least two points on a seven-category modified ordinal scale. Data were collected retrospectively from patients receiving sitagliptin from March 1 through April 30, 2020. </h2> <h2>Results. Of the 338 consecutive patients with type 2 diabetes and COVID-19 admitted in Northern Italy hospitals included in this study, 169 were on sitagliptin, while 169 were on standard-of-care. Treatment with sitagliptin at the time of hospitalization was associated with reduced mortality (18% vs. 37% of deceased patients; HR=0.44, 95% CI: 0.29-0.66, p=0.0001), with an improvement in clinical outcomes (60% vs. 38% of improved patients, p=0.0001) and with a greater number of hospital discharges (120 vs. 89 of discharged patients, p=0.0008), compared to patients receiving standard-of-care respectively. </h2> <h2>Conclusions. In this multicenter case-control retrospective observational study of patients with type 2 diabetes admitted to the hospital for COVID-19, sitagliptin treatment at the time of hospitalization was associated with reduced mortality and improved clinical outcomes as compared to standard-of-care treatment. The effects of sitagliptin in patients with type 2 diabetes and COVID-19 should be confirmed in an ongoing randomized, placebo-controlled trial. </h2>

scholarly journals Under-Treatment of Older Patients with Newly Diagnosed Epithelial Ovarian Cancer Remains an Issue

Cancers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 952
Author(s):  
Lucy Dumas ◽  
Rebecca Bowen ◽  
John Butler ◽  
Susana Banerjee
Keyword(s):  
Ovarian Cancer ◽  
Older Women ◽  
Older Patients ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Standard Of Care ◽  
First Line ◽  
Care Treatment ◽  
Platinum Based Chemotherapy ◽  
Standard Of Care Treatment

Older women with ovarian cancer have disproportionately poorer survival outcomes than their younger counterparts and receive less treatment. In order to understand where the gaps lie in the treatment of older patients, studies incorporating more detailed assessment of baseline characteristics and treatment delivery beyond the scope of most cancer registries are required. We aimed to assess the proportion of women over the age of 65 who are offered and receive standard of care for first-line ovarian cancer at two UK NHS Cancer Centres over a 5-year period (December 2009 to August 2015). Standard of care treatment was defined as a combination of cytoreductive surgery and if indicated platinum-based chemotherapy (combination or single-agent). Sixty-five percent of patients aged 65 and above received standard of care treatment. Increasing age was associated with lower rates of receiving standard of care (35% > 80 years old versus 78% of 65–69-year-olds, p = 0.000). Older women were less likely to complete the planned chemotherapy course (p = 0.034). The oldest women continue to receive lower rates of standard care compared to younger women. Once adjusted for Federation of Gynaecology and Obstetrics (FIGO) stage, Eastern Cooperative Oncology Group (ECOG) performance status and first-line treatment received, age was no longer an independent risk factor for poorer overall survival. Optimisation of vulnerable patients utilising a comprehensive geriatric assessment and directed interventions to facilitate the delivery of standard of care treatment could help narrow the survival discrepancy between the oldest patients and their younger counterparts.

Do elderly women with endometrial cancer receive standard of care treatment?

2021 ◽  
Vol 162 ◽  
pp. S139
Author(s):  
Michelle Soloff ◽  
Aaron Nizam ◽  
Ariel Kredentser ◽  
Bethany Bustamante ◽  
Weiwei Shan ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Elderly Women ◽  
Standard Of Care ◽  
Care Treatment ◽  
Standard Of Care Treatment

scholarly journals STEM-24. RADIATION-INDUCED EXTRACELLULAR VESICLE (EV) RELEASE OF miR-603 PROMOTES IGF1-MEDIATED STEM CALL STATE IN GLIOBLASTOMAS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii201-ii201
Author(s):  
Valya Ramakrishnan ◽  
Beibei Xu ◽  
Johnny Akers ◽  
Thien Nguyen ◽  
Jun Ma ◽  
...  
Keyword(s):  
Recipient Cell ◽  
Alkylating Agents ◽  
Acquired Resistance ◽  
Standard Of Care ◽  
Extracellular Vesicle ◽  
Cross Resistance ◽  
Dna Damages ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
The Impact

Abstract INTRODUCTION Release of exosomes and extracellular vesicles (EV) by glioblastomas plays key roles in modulating the tumor microenvironment and therapeutic response. Studies to date have largely focused on the impact of EV and exosomes on the recipient cell. Here, we demonstrate that EV-mediated export of a master-regulatory miRNA has fate-determining impacts on the cell releasing the EVs. METHODS microRNA (miRNA) profiling was performed using clinical glioblastoma specimens from the same patients derived pre- and post-standard of care treatment. Mechanism mediating altered miRNA homeostasis were assessed. RESULTS While the levels of nearly all miRNAs remained unchanged after standard-of-care treatment, decreased levels of few, select miRNAs were observed, including miR-603. In response to ionizing radiation (IR), but not temozolomide (TMZ), glioblastoma cell lines exhibited a time-dependent decrease in miR-603 levels. While miR-603 biogenesis and degradation remained unchanged after IR, IR induced an increase in EV-mediated export of miR-603. Profiling of miR-603 targets revealed that miR-603 repressed the insulin-like growth factor 1 (IGF1) and IGF1 receptor (IGF1R), genes required to maintain the cancer stem cell (CSC) state, as well as MGMT, the gene encoding a DNA repair protein that detoxifies temozolomide (TMZ) induced DNA damages. IR induced export of miR-603 de-repress IGF1/IGF1R to promote radiation resistance and de-repress MGMT to promote cross-resistance to TMZ and CCNU. Ectopic miR-603 expression overwhelmed cellular capacity for miR-603 export and synergized with the tumoricidal effects of IR and temozolomide (TMZ). CONCLUSIONS Radiation stimulated EV-mediated export of miR-603 to facilitate acquired resistance to IR and cross-resistance to DNA alkylating agents.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Sign in / Sign up

Export Citation Format

Share Document