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 Efficacy of a polyherbal formulation in the treatment of SARS CoV-2 disease: An open labelled feasibility study

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

Abstract Background: The ongoing pandemic caused by human coronavirus SARS CoV-2 has led to millions of death across the globe. Not only the virus is highly infectious, it is also mutates very easily. Currently there are no approved drugs for the therapeutic cure of COVID-19. The world is in search for an alternative that has antiviral properties directed against virus. Objective: The present study investigates an Ayurvedic polyherbal formulation of 13 herbs, named NOQ19, targeted against various viral proteins of COVID-19. Methodology: The study is a single arm, single centric, open label study of 161 RT-PCR positive COVID-19 patients. The enrolled participants were given the ayurvedic intervention, 2 tablets, thrice daily, to be consumed along with the standard care. Follow up COVID-19 RT- PCR was done on Day 5, Day 10 and Day 14 or until the patient turned negative. The time required for turning RT-PCR negative or become asymptomatic was noted. Results: Subjective analysis demonstrated that 98% of patients turned asymptomatic within 5 days of NOQ19 intake. Also 74% of the subjects turned RT-PCR Negative on Day 5 after taking NOQ19 along with the standard care provided. Also, none of the participant reported any adverse effect or side effect to the medication.Conclusion: NOQ19 Ayurvedic polyherbal formulation is an effective as well as safe alternative and adjunct treatment for the symptomatic management of COVID-19.

scholarly journals An integrative approach to clinical recovery for COVID-19 patients using an Ayurvedic formulation: A multicentric double-blind randomized control trial.

2021 ◽  
Author(s):  
Pankaj Bhardwaja ◽  
Kalaiselvan Ganapathy ◽  
Monika Pathania ◽  
K H Naveen ◽  
Jaykaran Charan ◽  
...  
Keyword(s):  
Side Effects ◽  
Standard Of Care ◽  
Integrated Approach ◽  
Placebo Control ◽  
Rt Pcr ◽  
Early Recovery ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery ◽  
Pcr Test

Abstract BackgroundTraditional medicine systems such as Ayurveda contain a vast repository of naturally occurring herbs with strong antimicrobial potency. A multitude of complementary therapies have been explored for their therapeutic role to treat COVID-19 during the pandemic. There have been promising results reported from in silico, in vitro and in vivo studies that need to be further explored in humans.ObjectiveThe present randomized placebo control trial evaluates the clinical efficacy of an integrated approach including Ayurvedic polyherbal formulation, NOQ19 in the improvement of mild to moderate category of COVID-19 infected patients.Patients and methodsA multicentric, randomized, placebo control design was adopted for the study. A total of 76 patients with positive COVID-19 RT-PCR test were enrolled in the study; 39 in the NOQ19 arm and 37 in the placebo arm. Patients were randomized and blinded to their respective intervention, which was provided along with the standard of care treatment. Rate of recovery assessment was done on Day 3, 5 and 7 via RT-PCR test to measure the rate of recovery. Blood markers were analysed on Day 0 and Day 7.OutcomesThe patients were assessed for rate of recovery via RT-PCR and improvement in blood biomarkers. They were also monitored for any adverse events or side effects of the drug.ResultsThe present study demonstrated a significant early recovery in the patients who took the NOQ19 formulation. Patients who received NOQ19 with the standard care of treatment showed clinical improvement in terms of oxygen requirement, breathlessness and SpO2, though the difference was not statistically significant. Moreover, no side effects were observed with the use of NOQ19.ConclusionAn overall integrated approach of standard of care treatment with Ayurvedic formulation (NOQ19) results in early clinical outcome in the management of mild to moderate cases of COVID-19.

scholarly journals Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 patients: A placebo controlled pilot study among moderate-severe patients

2021 ◽  
Author(s):  
Abhishek Arun ◽  
Amit Gupta ◽  
Saumya Subramanian ◽  
Divya Kanchibhotla
Keyword(s):  
Clinical Improvement ◽  
Standard Of Care ◽  
Rt Pcr ◽  
Blood Biomarkers ◽  
Early Recovery ◽  
Improvement Rate ◽  
Health Crisis ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Rate Of Recovery

Abstract Introduction: The COVID-19 pandemic is a global health crisis that has affected millions of people worldwide. Apart from measures taken to reduce the transmission of virus and provide symptomatic relief to patients, a potent drug targeted against the virus is required to manage the disease. Traditional medicines with an array of phytochemicals and potent anti-viral properties, can provide alternate solution in the therapeutic cure of COVID-19.Objective: The present study investigates the efficacy of an Ayurvedic formulation, NOQ19, on the rate of recovery and clinical improvement among moderate-severe COVID-19 infected patients who were not on a ventilator or in intensive care unit.Methods: A placebo controlled randomized study design, with 1:1 ratio between the intervention and placebo arms was adopted. The participants were provided their respective intervention along with the standard of care treatment. A follow up was conducted on Day 7 and Day 10 to assess the rate of recovery and clinical improvement. Rate of recovery was the primary outcome measured and was determined by a negative result on the RT-PCR test. The secondary outcomes included clinical improvement among patients and were measured using blood biomarkers.Results: The NOQ19 arm had a higher percentage of population who turned RT-PCR negative on Day 7 (23%) when compared to the placebo arm (11%). Further subgroup analysis demonstrated that for both moderate and severe patients, there were a greater percentage of population who were RT-PCR negative in the NOQ19 arm compared to the placebo arm at Day 7: (NOQ-19: 22.22%, Placebo: 14.29% for moderate patients), (NOQ19: 23.08% Placebo: 0% for severe patients). By Day 10, both populations depicted an almost similar percentage of the population who were RT- PCR negative. Both the groups demonstrated an improvement in blood biomarkers, although the improvement was greater in the NOQ19 arm. None of the patients in the intervention arm reported any adverse events.Conclusion: The results of this pilot RCT indicates that NOQ19 along with standard of care treatment can be considered as an effective therapy for COVID-19 and aid early recovery from the disease.

Ayurveda and Management of COVID-19 in Rural Indian Population: A pilot, double blind, randomized control trial

2021 ◽  
Author(s):  
K P Bharath Chandra ◽  
Saumya Subramanian ◽  
Rohini Wadhawan ◽  
Akhilesh Mohan Wodeyar ◽  
Alefia Zakir Marfatia ◽  
...  
Keyword(s):  
Randomized Control Trial ◽  
Standard Of Care ◽  
Rt Pcr ◽  
Early Recovery ◽  
Double Blind ◽  
Study Duration ◽  
Care Treatment ◽  
Significant Difference ◽  
Standard Of Care Treatment ◽  
Randomized Control

Abstract Background The SARS-CoV-2 virus responsible for the COVID-19 pandemic is a highly contagious and rapidly mutating virus. The COVID-19 pandemic has affected millions globally over the last 18 months and continues to overwhelm the healthcare system in several countries to date. The healthcare and scientific community has been vigorously searching for ways to manage the disease. Several solutions based on traditional systems of medicine like Ayurveda are also being explored for their effectiveness in managing COVID-19. The study explored the efficacy of a 19 ingredient Ayurvedic polyherbal formulation called NOQ19, on the recovery of mild, RT-PCR positive COVID-19 patients. Methods This was a prospective, double blind, randomized control trial that included 92 patients with a RT-PCR positive mild case of COVID-19. The patients were enrolled from rural areas of Karnataka, a state in India. The patients were randomized between the NF2 and placebo arms, in a 1:1 ratio, and were provided their respective intervention, along with the standard of care treatment (SOC). The trial took place at the Community Care Center, Konnanuru, Hassan, Karnataka. The study duration was around 2 months and the follow-up period for an individual patient was 14 days. RT-PCR analysis was done at baseline, Day 3, 7 and 10. Blood markers to track inflammation were assessed at baseline, Day 3 and 7. Result A statistically significant difference was observed between the two groups with regards to the percentage of population who turned RT-PCR negative on Day 3 and Day 10. On all three assessment time points (Day 3, 7 and 10), the NF2+SOC arm showed a greater percentage of population who were RT-PCR negative compared to the placebo+SOC arm: Day 3 (NF2 -19%, Placebo - 0%) ; Day 7 (NF2- 41%, Placebo - 19%) ; Day 10 (NF2-73%, Placebo 44%). No significant changes were observed in blood markers for both the groups. Conclusion NF2 administered along with standard of care treatment aided early recovery from COVID-19 as demonstrated by a higher percentage of population who were RT-PCR negative on Day 3, 7 and 10. No side effects were observed during the entire study duration. Early recovery of patients is essential for rational usage of limited healthcare resources in a pandemic.

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.

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