scholarly journals A prospective, open label clinical study to evaluate the safety, efficacy and tolerability of azadvir herbal steam inhaler in asymptomatic, mildly symptomatic COVID-19 patients and health care workers posted to covid wards

Author(s):  
Ajitha Pottirayil ◽  
Shankar A. S. ◽  
Shaji Kannoth ◽  
Poorna Prasad ◽  
Sharath Kumar B. Jaikar ◽  
...  

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications even with currently available of standard of care. Additional antiviral and immune boosters are the need of hour to treat COVID-19 and to prevent post covid complications.Methods: In this study we enrolled 40 asymptomatic to mild COVID-19 patients to receive azadvir herbal steam inhaler along with standard of care. We evaluated the benefits of azadvir herbal steam inhaler by assessing RT-PCR conversion, clinical outcomes and improvement in immune markers (LDH, CRP, D-DIMER).Results: At the end of the study the immune markers improved significantly in study patients. In mild symptomatic cases IL-6 was 23.2 pg/ml on day 0 and 21.8 pg/ml on day 14. Reduction in IL-6 in mild symptomatic patients was statistically highly significant (p=0.0056). Mean IL-6 in asymptomatic patients was 22.3 pg/ml on day 0 and 21.1 pg/ml on day 14. Reduction in IL-6 in asymptomatic patients was statistically highly significant (p=0.0035).  Mean D-dimer was showing decreasing trend from day 0 to day 14 in mild symptomatic patients. In asymptomatic patients D dimer was 0.8 µg/ml on day 0 and 0.6 µg/ml on day 14. D-dimer decreased significantly from day 0 to day 14 (p value =0.0013). Mean LDH values on day 0 in mild symptomatic patients was 319.4 U/l and 219.3 on day 14. The reduction in LDH values in mild symptomatic patients is statistically significant (p value <0.0122). In asymptomatic patients mean LDH values on day 0 was 237 U/l and 194 U/l on day 14. The reduction in LDH values in asymptomatic group was statistically significant. Mean CRP values in mild symptomatic patients on day 0 was 12.2 mg/l and 3.8 mg/l on day 14. There was significant reduction in CRP values in mild symptomatic group which was statistically significant (p value =0.0546). Mean CRP values in asymptomatic patients on day 0 was 4.9 mg/l and 2.8 mg/l on day 14. There was significant reduction in mean CRP in asymptomatic patients which was statistically significant (p value =0.0446). In the present study all 40 patients (100%) cleared the virus and became negative for RT PCR test within 6 days. None of the patients progressed to severe COVID-19 and none of the patients succumbed to the disease.Conclusions: Azadvir accelerated recovery of COVID-19 patients by RT-PCR conversion, early improvement in clinical symptoms and immune markers in this study. This study results clearly indicates that azadvir has antiviral, immune booster activity and has definitive role in the management of asymptomatic to mild COVID-19 patients along with standard of care (CTRI no. CTRI/2020/06/026181).

Author(s):  
A. Gopal Rao ◽  
Shankar Achar Somashekar ◽  
Poorna Prasad ◽  
Manjunath Reddy Lekkala ◽  
Sreenivasa Hanumanthaiah ◽  
...  

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications. Effective antiviral and immune boosters are need of hour to treat COVID-19 as well as post COVID complications.Methods: In this study involving mild COVID-19 we randomized 40 patients to receive a Herbovir syrup along with standard of care (SOC) or SOC alone in 1:1 ratio. We evaluated the benefits of Herbovir syrup by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer).Results: At the end of the study the immune markers in Herbovir group improved significant compared to control group. In patients who received Herbovir, LDH decreased from 334 U/l at baseline to 254 U/l at the end of treatment (p value <0.009), CRP decreased from 7.4 mg/l to 3.1 mg/l (p value=0.0171) and D-dimer decreased from 0.610 mg/l at baseline to 318 mg/l at the end of study (p value=0.001). TLC values did not go below normal range in Herbovir group whereas 8 patients in control group had low TLC at the end of study. Early recovery from COVID 19 symptoms was observed in >75% patients in Herbovir treated group.Conclusions: Herbovir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that Herbovir syrup has antiviral, immune booster activity and has definitive role in the management of mild COVID-19 patients along with standard of care. (Funded by Venkat pharma. CTRI no. CTRI/2020/08/027041).


Author(s):  
C. R. Jayanthi ◽  
Shankar A. S. ◽  
M. Ravi Shankar ◽  
Lakshmana Perumal S. P. T. ◽  
Manjunath Reddy L. ◽  
...  

Background: Coronavirus can cause pneumonia, respiratory failure and death. The emergence of novel coronavirus has posed a challenging situation that warrants urgent global attention. Currently there was no effective therapy available for COVID-19 and hence antiviral and immune modulators are most sought after medicines to manage complications of COVID-19.Methods: In this study involving mild COVID-19 we randomized 42 patients to receive a MyVir tablets twice daily along with standard of care (SOC) or SOC alone in 1:1 ratio for 14 days. We evaluated the benefits of MyVir tablets by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer, TLC).Results: At the end of the study the immune markers in MyVir group improved significantly compared to control group. In patients who received MyVir, CRP decreased from 3.3 mg/l to 1.7 mg/l (p=0.0171). D-dimer decreased from 0.589 on day 0 to 0.368 on day 14 (p=0.03) and LDH decreased from 224 U/l on day 0 to 158 U/l on day 14 in test group (p=0.05). TLC showed favorable improvement in study group compared to control group. Early recovery from COVID-19 symptoms was observed in patients on MyVir treated group. Patients treated with MyVir tablets reduced the duration of hospitalization when given along with standard of care.Conclusions: MyVir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that MyVir tablets has antiviral, immune booster activity. Hence this study provides evidence that MyVir has definitive role in the management of mild COVID-19 patients along with standard of care (funded by Mi Lab Life Sciences(P) Ltd. CTRI no. CTRI/2020/05/024967).


Author(s):  
Yu Lei ◽  
Xiaobo Huang ◽  
Bamu SiLang ◽  
YunPing Lan ◽  
Jianli Lu ◽  
...  

AbstractCoronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, has rapidly spread throughout China, but the clinical characteristics of Tibetan patients living in the Qinghai-Tibetan plateau are unknown. We aimed to investigate the epidemiological, clinical, laboratory and radiological characteristics of these patients. We included 67 Tibetan patients with confirmed SARS-CoV-2 infection. The patients were divided into two groups based on the presence of clinical symptoms at admission, with 31 and 36 patients in the symptomatic and asymptomatic groups, respectively. The epidemiological, clinical, laboratory and radiological characteristics were extracted and analysed. No patient had a history of exposure to COVID-19 patients from Wuhan or had travelled to Wuhan. The mean age of Tibetan patients was 39.3 years and 59% of the patients were male. Seven patients presented with fever on admission and lymphocytopenia was present in 20 patients. 47 patients had abnormal chest CTs at admission instead of stating that 20 were unchanged. Lactate dehydrogenase levels were increased in 31 patients. Seven patients progressed to severe COVID-19; however, after treatment, their condition was stable. No patients died. Of the 36 asymptomatic patients, the mean age was younger than the symptomatic group (34.4±17.3vs 44.9±18.1 years, P=0.02). Lymphocyte count and prealbumin levels were higher in the asymptomatic group than the group with clinical symptoms (1.6±0.5 vs 1.3±0.6 and 241.8±68.2 vs 191.9±60.3, respectively; P<0.05). Imported cases of COVID-19 in Tibetan patients were generally mild in this high-altitude area. Absence of fever or radiologic abnormalities on initial presentation were common.


2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Fahimeh Safarnezhad Tameshkel ◽  
Ali Salimi Jeda ◽  
Ahmad Tavakoli ◽  
Mohammad Hadi Karbalaie Niya ◽  
Morteza Izadi ◽  
...  

Background: Human rhinovirus (HRV) is still the most prevalent viral infection in humans and a significant cause of acute respiratory tract infections (ARTIs) in many communities, including military personnel undergoing basic training. Objectives: In this research, we assessed the molecular epidemiology, genotyping, and phylogenetic classification of HRVs in Iranian military trainees with respiratory infections (RI). Methods: For HRV identification and genotyping, respiratory specimens were obtained, and RT-PCR was conducted for genotyping and phylogenetic analysis of HRV utilizing primers for the 5-UTR region. Results: Among 400 Iranian military trainees (average age of 21 ± 4 years, the range of 18 - 57 years) with respiratory infections, HRV was detected in 29 patients (7%) using RT-PCR. The direct sequencing of PCR products from 10 specimens showed that the incidence of type A (n = 5, 50%) was higher than that of type B (n = 4, 40%) and type C (n = 1, 10%). There were no significant associations between HRV and respiratory and clinical symptoms, blood group, and indoor or outdoor conditions (P-value > 0.05). Conclusions: This research was the first to record HRV as a significant cause of respiratory problems among military trainees in Iran, with a frequency of 7%. The most prevalent genotype was HRV-A, which may be applicable in epidemiological and clinical studies, as well as vaccination plans.


2013 ◽  
Vol 169 (5) ◽  
pp. 665-672 ◽  
Author(s):  
Claire Blanchard ◽  
Muriel Mathonnet ◽  
Frédéric Sebag ◽  
Cécile Caillard ◽  
Antoine Hamy ◽  
...  

Objective and backgroundMost primary hyperparathyroidism (pHPT) patients do not conform to the guidelines for parathyroidectomy established by an international panel of specialists and have a mild pHPT. This group is typically defined as ‘asymptomatic’. The primary aim of this study was to determine symptom improvement in this ‘asymptomatic’ group after parathyroidectomy. Secondly, we aimed to create a preoperative clinical score predicting postoperative symptom resolution.DesignA prospective nonrandomized study included patients with mild pHPT.MethodsA questionnaire (22 items) was given to ‘asymptomatic’ patients preoperatively and at 3, 6, and 12 postoperative months. A logistic regression was performed to create a preoperative clinical score.ResultsOne hundred and sixteen patients were included. Postoperatively, HPT was resolved in 98% of patients. Twelve of 22 nonspecific symptoms were improved at 1 year. Subgroups analysis showed a greater improvement in patients <70 years and those with a serum calcium level ≥2.6 mmol/l preoperatively. A clinical score, based on age and five symptoms, was established to predict the clinical improvement after surgery in mild pHPT patients with a positive predictive value of 81%.ConclusionPatients with asymptomatic pHPT have clinical improvement of their symptoms postoperatively even after 1 year. Younger patients and those with higher preoperative calcium levels show the best improvement.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15001-e15001
Author(s):  
Barbara Hickingbottom ◽  
Raphael Clynes ◽  
John Desjarlais ◽  
Caiyan Li ◽  
Ying Ding

e15001 Background: Interim safety and PD data from an ongoing first-in-human, multi-center, open-label dose escalation study of XmAb20717 (XmAb20717-01; NCT03517488) are reported here. The primary objectives were to determine safety, tolerability, and the MTD and/or recommended doses (RDs). Secondary objectives included preliminary anti-tumor activity and PK/PD. Methods: A 3+3 dose escalation design was used to establish an MTD/RD(s) for infusions on Days 1 and 15 of each 28-day cycle. DLT evaluation was based on Cycle 1 through Day 28. Patients with selected solid tumors (in indications both with and without approved checkpoint therapy) who have exhausted standard of care are eligible. Results: As of 05FEB 2020, 34 patients were treated in cohorts 1-6 at fixed doses of 0.15 to 10 mg/kg. Patients had a median age of 57 years (range 32-81), a median time since initial diagnosis of 42 months (range 3 -313), and a median of 4 prior systemic therapies (range 0-9). 68% of patients had a TNM stage of III/IV, and 68% had been exposed to checkpoint therapy. XmAb20717 treatment was generally well tolerated through the highest dose cohort tested. Overall rates of Gr3/4 immune-related AEs occurred in 8 (24%) patients including elevations of transaminases 3 (9%), rash 2 (6%), lipase and amylase 1 (3%, without clinical symptoms or radiographic evidence of pancreatitis), lipase (alone) 1 (3%), pruritus 1 (3%), hyperglycaemia 1 (3%), arthritis 1 (3%) and colitis 1 (3%), all reversible. Responses were evaluated based on RECIST 1.1 criteria, and there was 1 CR reported (melanoma, progressed on prior pembrolizumab) at 10 mg/kg (highest dose level). Dose-dependent pharmacodynamic activity consistent with dual PD-1/CTLA-4 blockade was noted, namely a proliferative burst of both CD8 and CD4 T cells and induction of IFN-inducible chemokines (Table). Conclusions: XmAb20717 is generally safe and has demonstrated PD activity in heavily pretreated patients with selected advanced solid tumors. Dose escalation continues. Clinical trial information: NCT03517488 . [Table: see text]


2021 ◽  
Author(s):  
Divya Kanchibhotla ◽  
Prateek Harsora ◽  
Saumya Subramanian ◽  
Ravi reddy ◽  
Hari Venkatesh

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.


2022 ◽  
Vol 13 (1) ◽  
pp. 13-18
Author(s):  
Jayasri Helen Gali ◽  
Manasa Musku ◽  
Devireddy Pallavi Reddy ◽  
Vimala Thomas ◽  
Ehsan Ahmed Khan

Background: Emergence of variants with specific mutations in key epitopes in the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) raises concerns pertinent to its severity. Aims and Objectives: To assess the demographics, clinico-radiological pattern, and outcome of reverse transcription-polymerase chain reaction (RT-PCR) positive isolated coronavirus disease 2019 (COVID-19) patients arrived from the United Kingdom (UK). Materials and Methods: A cross-sectional, observational study was conducted in RT-PCR positive COVID-19 patients arrived from the UK, from December 2020 to February 2021. Nasopharyngeal samples of all patients were sent for whole-genome sequencing of SARS-CoV-2. The aimed parameters were compared between the B.1.17 positive and non-B.1.1.7 groups, among the people, arrived from the UK. All statistical tests with P<0.05 were considered significant. Results: A total of 59 SARS-CoV2 infected patients, who arrived from the UK, were isolated from December 2020 to February 2021 at Telangana Institute of Medical Sciences hospital, Hyderabad, were enrolled in the study. Of these, 27 patients (mean age-31.81±11.28 years) were infected with the B.1.1.7, diagnosed by whole genomic sequencing. Males were predominant in our study. Personal habits such as smoking, alcohol intake were higher among the sequenced group with a significant P<0.05. The most common symptoms observed in the sequenced group were cough (22.22%), sore throat (22.22%), cold (11.11%), fever (11.11%), and in the unsequenced group were cough (22.22%), cold (6.25%), fever (6.25%). In the sequenced group, chest X-ray posteroanterior view was normal in 74%, patchy ground-glass opacities was observed in 25.92% patients, whereas in the unsequenced group it was 84.37% and 15.62%, respectively. Asymptomatic patients, observed in the sequenced and unsequenced group were 48.18% and 78.12%, respectively, and symptomatic patients were 51.85% and 21.87%, respectively. We found a statistically significant difference between sequenced and unsequenced patients in the asymptomatic group with a significant P<0.05. In the sequenced and unsequenced group, mild cases were 48.18% and 18.75%, moderate cases were 3.7% and 3.12%, respectively. We found no evidence of an association between disease severity and lineage B.1.17. Conclusion: Our data, within the context and limitations of a real-world study, provide initial reassurance that severity in hospitalized patients with B.1.1.7 is not markedly different from severity in those without B.1.1.7.


2018 ◽  
Vol 6 (1) ◽  
Author(s):  
Urania Rappo ◽  
Sailaja Puttagunta ◽  
Vadym Shevchenko ◽  
Alena Shevchenko ◽  
Alena Jandourek ◽  
...  

Abstract Background Osteomyelitis is a challenging infection that can involve 4–6 weeks of intravenous (IV) antibiotics. Dalbavancin, approved for acute bacterial skin and skin structure infections, has potent activity against gram-positive pathogens. This study assessed the efficacy and safety of dalbavancin as a 2-dose regimen for osteomyelitis. Methods This study was a randomized, open-label, comparator-controlled trial in adults with a first episode of osteomyelitis defined by clinical symptoms, radiologic findings, and elevated C-reactive protein. Patients were randomized 7:1 to dalbavancin (1500 mg IV on days 1 and 8) or standard of care (SOC) for osteomyelitis (oral or IV) per investigator judgment for 4–6 weeks. The primary endpoint was clinical response at day 42, defined as recovery without need for additional antibiotics in the clinically evaluable (CE) population. Clinical response was also assessed at day 21, 6 months, and 1 year. Results Eighty patients were randomized to dalbavancin (n = 70) or SOC (n = 10). All had baseline debridement; Staphylococcus aureus was the most common pathogen (60% of patients). Clinical cure at day 42 was seen in 65/67 (97%) and 7/8 (88%) patients in the dalbavancin group and SOC group in the CE population, respectively. Clinical response was similar in the dalbavancin group at day 21 (94%), 6 months, and 1 year (96%). Treatment-emergent adverse events occurred in 10 patients in the dalbavancin group; no patient discontinued treatment due to an adverse event. Conclusions A 2-dose regimen of weekly dalbavancin is effective and well tolerated for the treatment of osteomyelitis in adults. Clinical Trials Registration NCT02685033.


Author(s):  
Santiago A. Quiroga ◽  
Carolina Hernández ◽  
Sergio Castañeda ◽  
Paula Jimenez ◽  
Laura Vega ◽  
...  

Abstract Background There is limited and controverting evidence looking at possible associations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA copies and patient variables in large cohorts of symptomatic and asymptomatic patients. Methods We studied 2275 symptomatic and asymptomatic patients from Colombia with coronavirus disease 2019 (COVID-19) and analyzed the associations between RT-PCR cycle threshold (Ct) value with gender, age, comorbidities, symptomatology, and disease severity. Results 15.4 % of the samples (n = 428) reported at least one comorbidity. There were 2011 symptomatic cases (72.4 %), being the most common reported symptom cough (57.2 %, n = 1586). Respiratory distress was present in 21.4 % of patients (n = 595), and 435 patients (15.6 %) required hospital admission. We observed that patients with no prior medical history harbored higher RNA copies than patients with comorbidities (p = 0.02). No significant differences in RNA copies were observed between symptomatic and asymptomatic patients (p = 0.82). Strong correlations were detected between Ct values and the presence of odynophagia (p = 0.03), diarrhea (p = 0.04), and headache (p = 0.0008). An inverse association was found between RNA copy number and markers of disease severity, namely, respiratory distress (P < 0.0001) and hospitalization requirement (P < 0.0001). Conclusions SARS-CoV-2 RT-PCR cycle thresholds reveal strong associations with a prior medical history, specific symptomatology, and disease severity markers. Further research controlling potential confounding variables needs to be conducted to evaluate the nature and usefulness of these associations in managing COVID-19 patients.


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