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 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 Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background: The COVID-19 pandemic, caused by the human coronavirus SARS CoV-2, has led to millions of deaths across the globe. Not only is the SARS CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective: The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results: A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C , Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication.Conclusion: NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

scholarly journals Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background The COVID-19 pandemic, caused by the human coronavirus SARS CoV-2, has led to millions of deaths across the globe. Not only is the SARS CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication. Conclusion NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

scholarly journals Rate of Recovery and Symptomatic Efficacy of a Polyherbal AYUSH Formulation in the Treatment of SARS CoV-2 disease: A Single-arm trial

2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh
Keyword(s):  
Standard Of Care ◽  
Rt Pcr ◽  
Open Label ◽  
Subjective Analysis ◽  
Polyherbal Formulation ◽  
Care Treatment ◽  
Symptomatic Management ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Time Required

Abstract Background The COVID-19 pandemic, caused by the human coronavirus SARS- CoV-2, has led to millions of deaths across the globe. Not only is the SARS-CoV-2 virus highly infectious, it also mutates very easily. This creates additional challenges for development of robust therapeutic solutions. Along with modern system of healthcare, there is a definite need for exploring natural plant based antiviral compounds directed against the SARS CoV-2 virus. Objective The present observational study investigates the efficacy of an Ayurvedic polyherbal formulation of 19 ingredients, NOQ19, in the management of COVID-19. Methodology: A single arm, single centric, open label study design was adopted for this feasibility study. 161 RT-PCR positive COVID-19 patients were enrolled. The enrolled participants were provided the Ayurvedic intervention, 2 tablets of NOQ19, thrice daily along with the standard of care treatment. Follow up COVID-19 RT- PCR tests were conducted on Day 5, Day 10 and Day 14, or until the patient turned negative. The time required for testing negative on the RT-PCR test or becoming asymptomatic was noted. Results A subjective analysis demonstrated that 74% of patients turned RT-PCR negative within 5 days of taking NOQ19. Additionally, 98% of the subjects turned RT-PCR Negative on Day 10 after taking NOQ19 in addition to the standard of care treatment of Vitamin C, Zinc and antipyretic (as necessary). None of the participants reported any adverse or side effects to the medication. Conclusion NOQ19 Ayurvedic polyherbal formulation can be an effective and safe option for the symptomatic management of COVID-19.

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 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 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 Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Iwein Gyselinck ◽  
◽  
Laurens Liesenborghs ◽  
Ewout Landeloos ◽  
Ann Belmans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Cytokine Signaling ◽  
Nasopharyngeal Swab ◽  
The Novel ◽  
Proof Of Concept ◽  
Open Label ◽  
Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

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