A Multi-center, Randomized, Open-label, Controlled Trial to Evaluate the Efficacy and Tolerability of Hydroxychloroquine (HCQ) in Adult Patients with Mild to Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment v1 (protocols.io.bmfak3ie)

protocols.io ◽  
2020 ◽  
Author(s):  
shuhsingcheng not provided
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Adult Patients ◽  
Open Label ◽  
Care Treatment ◽  
Standard Of Care Treatment

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 117. Adjunctive Daptomycin in the Treatment of staphylococcus Aureus Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S187-S187
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De L’Etoile-Morel ◽  
Katryn Paquette ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Median Duration ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Absolute Difference ◽  
Double Blind ◽  
Intention To Treat ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Treat Analysis

Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures

scholarly journals Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Elena Diago-Sempere ◽  
José Luis Bueno ◽  
Aránzazu Sancho-López ◽  
Elena Múñez Rubio ◽  
Ferrán Torres ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Infections ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Viral Disease ◽  
Multicenter Trial ◽  
Adult Patients ◽  
Ordinal Scale ◽  
Efficacy And Safety ◽  
Open Label

Abstract Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/design The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020.

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 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.

Adjunctive Daptomycin in the Treatment of Methicillin-Susceptible Staphylococcus aureus Bacteremia: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De l’Etoile-Morel ◽  
Katryn Paquette ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Median Duration ◽  
Controlled Trial ◽  
Bloodstream Infections ◽  
Standard Of Care ◽  
Absolute Difference ◽  
Intention To Treat ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Treat Analysis

Abstract Background Bloodstream infections (BSI) with methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine the efficacy of synergistic treatment of daptomycin when given with either cefazolin or cloxacillin for the treatment of MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). Conclusion Among patients with MSSA bloodstream infections, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia and should not be routinely considered.

Sign in / Sign up

Export Citation Format

Share Document