scholarly journals Pathogenesis-based pre-exposure prophylaxis associated with low risk of SARS-CoV-2 infection in healthcare workers at a designated Covid-19 hospital

2020 ◽  
Author(s):  
Michael V. Dubina ◽  
Veronika V. Gomonova ◽  
Anastasia E. Taraskina ◽  
Natalia V. Vasilyeva ◽  
Sergey A. Sayganov
Keyword(s):  
Healthcare Workers ◽  
Low Dose ◽  
Current Knowledge ◽  
Single Centre ◽  
Open Label ◽  
Safety And Efficacy ◽  
Immunological Tests ◽  
Single Centre Study ◽  
New Research ◽  
Exposure Prophylaxis

AbstractAt present, no agents are known to be effective in preventing Covid-19. Based on current knowledge of the pathogenesis of this disease, we suggest that SARS-CoV-2 infection might be attenuated by directly maintaining innate pulmonary redox, metabolic and dilation functions using well-tolerated medications that are known to serve these functions, specifically, using a low dose aerosolized combination of glutathione, inosine and potassium. From June 1 to July 10, 2020, we conducted a low-intervention open-label single-centre study to evaluate safety and efficacy of pre-exposure prophylaxis (PrEP) with the aerosolized combination medications (ACM) on SARS-CoV-2 incidence in 99 healthcare workers (HCWs) at a hospital that was designated to treat Covid-19 patients. We also retrospectively compared SARS-CoV-2 incidence in the ACM users to that in 268 untreated HCWs at the same hospital. Eligible participants received an aerosolized combination of 21.3 mg/ml glutathione, 8.7 mg/ml inosine in 107 mM potassium solution for 14 days. The main outcome was the frequency of laboratory confirmed SARS-CoV-2 cases, defined as individuals with positive genetic or immunological tests within 28 days of the study period. During the PrEP period, solicited adverse events occurred in five participants; all were mild and transient reactions. SARS-CoV-2 was detected in 2 ACM users (2%, 95% CI: 0.3% to 7.1%), which was significantly less than the incidence in 24 nonusers (9%, 95% CI: 5.8% to 13.0%; P = 0.02). Our findings might be used either to prevent SARS-CoV-2 infection, or to support ongoing and new research into more effective treatments for Covid-19. The study was registered with rosrid.ru, AAAA-A20-120061690058-2, and isrctn.com, ISRCTN34160010.

scholarly journals Pathogenesis-based preexposure prophylaxis associated with a low risk of SARS-CoV-2 infection in healthcare workers at a designated COVID-19 hospital: a pilot study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Michael V. Dubina ◽  
Veronika V. Gomonova ◽  
Anastasia E. Taraskina ◽  
Natalia V. Vasilyeva ◽  
Sergey A. Sayganov
Keyword(s):  
Healthcare Workers ◽  
Low Dose ◽  
Current Knowledge ◽  
Open Label ◽  
Safety And Efficacy ◽  
Preexposure Prophylaxis ◽  
Immunological Tests ◽  
Single Center Study ◽  
New Research ◽  
Center Study

Abstract Background At present, no agents are known to be effective at preventing COVID-19. Based on current knowledge of the pathogenesis of this disease, we suggest that SARS-CoV-2 infection might be attenuated by directly maintaining innate pulmonary redox, metabolic and dilation functions using well-tolerated medications that are known to serve these functions, specifically, a low-dose aerosolized combination of glutathione, inosine and potassium. Methods From June 1 to July 10, 2020, we conducted a pilot, prospective, open-label, single-arm, single-center study to evaluate the safety and efficacy of preexposure prophylaxis (PrEP) with aerosolized combination medication (ACM) on the incidence of SARS-CoV-2 positivity in 99 healthcare workers (HCWs) at a hospital designated for treating COVID-19 patients. We compared SARS-CoV-2 positivity in ACM users to retrospective data collected from 268 untreated HCWs at the same hospital. Eligible participants received an aerosolized combination of 21.3 mg/ml glutathione and 8.7 mg/ml inosine in 107 mM potassium solution for 14 days. The main outcome was the frequency of laboratory-confirmed SARS-CoV-2 cases, defined as individuals with positive genetic or immunological tests within 28 days of the study period. Results SARS-CoV-2 was detected in 2 ACM users (2, 95% CI: 0.3 to 7.1%), which was significantly less than the incidence in nonusers, at 24 (9, 95% CI: 5.8 to 13.0%; P = 0.02). During the PrEP period, solicited adverse events occurred in five participants; all were mild and transient reactions. Conclusions Our findings might be used either to prevent SARS-CoV-2 infection or to support ongoing and new research into more effective treatments for COVID-19. Trial registration ISRCTN, ISRCTN34160010. Registered 14 September 2020 - Retrospectively registered.

scholarly journals Adalimumab in patients with Crohn’s disease - safety and efficacy in an open-label single centre study

2007 ◽  
Vol 25 (7) ◽  
pp. 787-796 ◽  
Author(s):  
J. SEIDERER ◽  
S. BRAND ◽  
J. DAMBACHER ◽  
S. PFENNIG ◽  
M. JÜRGENS ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Single Centre ◽  
Open Label ◽  
Safety And Efficacy ◽  
Centre Study ◽  
Single Centre Study

scholarly journals P1775CMV VIREMIA IN KIDNEY TRANSPLANT RECIPIENTS RECEIVING BASILIXIMAB OR LOW DOSE ANTI THYMOCYTE GLOBULIN INDUCTION WITHOUT VALGANCICLOVIR PROPHYLAXIS- SINGLE CENTRE EXPERIENCE IN INDIA

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Reetesh Sharma ◽  
Mayur Maksana ◽  
Naresh Trehan
Keyword(s):  
Acute Rejection ◽  
Low Dose ◽  
Invasive Disease ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Cmv Infection ◽  
Single Centre ◽  
Open Label ◽  
Single Centre Study ◽  
Group 1

Abstract Background and Aims CMV is a major cause of morbidity in transplant recipients and manifests as tissue invasive disease or CMV viral syndrome. Controversy exists regarding best method for CMV prevention. Therefore, we intended to evaluate incidence of CMV viremia and symptomatic CMV infection in adult KTR with basiliximab or antithymocyte globulin (ATG) induction without the use of valganciclovir prophylaxis. This study will help developing a protocol for management of CMV infection/disease in Indian patients since there is no such data amongst Indians. Method A prospective, open-label, single centre study. Patients were monitored for CMV DNA-PCR twice a week for month 1 post-transplant, once a week in month2, and then every 2 weeks in month 3, and then once a month from month 4 to 6. Results We included 17 patients with low-dose ATG induction (group1) and 20 patients with Basiliximab induction (group2). Mean recipient age was 42.9 and 45.9 yr in group 1 and 2 whereas mean donor age was 50.6 and 51.6 yr respectively. Male recipients were 76.4% (13/17) and 65% (13/20) in group 1 and 2 respectively; male donors were 11.7% (2/17) and 20% (4/20) respectively (not signficant). Average HLA mismatches were 3.4/6 and 3.7/6 (not significant). In group1 average transfusions per patient were 6units (vs 1.7units in group2) and 65% pts in group1 had >3 units transfusion (p<0.05). Mean follow-up was 12.7 and 20.7 months respectively. Incidence of acute rejection was 5.8% (1/17) and 10% (2/20) in group 1 and 2 respectively. (not significant). Incidence of CMV viremia requiring valganciclovir therapy was 11.6% (2/17) and 10% (2/20) in group 1 and 2 respectively. (not significant). No patient developed CMV disease. Mean serum creatinine was 1.1 and 1.09 mg/dL at 1 month and 1.2 and 1.14 mg/dL at 3 months (not significant) Conclusion The incidence of CMV viremia is low and not significantly different in patients receiving basiliximab or low dose ATG induction in living donor kidney transplants on tacrolimus based immunosuppression. In our study patients in ATG group had significantly more transfusions vs basiliximab group and hence were more sensitised. Still the incidence of acute rejection remained low in both these groups (5.8% and 10%). Hence universal prophylaxis with valganciclovir may not be required in all the patients with basiliximab and low dose ATG induction especially in developing countries where cost of therapy is borne by the patients.

scholarly journals Platform study of genotyping-guided precision medicine for rare solid tumours: a study protocol for a phase II, non-randomised, 18-month, open-label, multiarm, single-centre clinical trial testing the safety and efficacy of multiple Chinese-approved targeted drugs and PD-1 inhibitors in the treatment of metastatic rare tumours

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044543
Author(s):  
Shuhang Wang ◽  
Hui-Yao Huang ◽  
Dawei Wu ◽  
Hong Fang ◽  
Jianming Ying ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Targeted Therapy ◽  
Single Agent ◽  
Solid Tumours ◽  
Targeted Drugs ◽  
Gene Fusions ◽  
Single Centre ◽  
Open Label ◽  
Safety And Efficacy ◽  
Rare Tumours

IntroductionLimited clinical studies have been conducted on rare solid tumours, and there are few guidelines on the diagnosis and treatment, including experiences with targeted therapy and immunotherapy, of rare solid tumours in China, resulting in limited treatment options and poor outcomes. This study first proposes a definition of rare tumours and is designed to test the preliminary efficacy of targeted and immunotherapy drugs for the treatment of rare tumours.Methods and analysisThis is a phase II, open-label, non-randomised, multiarm, single-centre clinical trial in patients with advanced rare solid tumours who failed standard treatment; the study aims to evaluate the safety and efficacy of targeted drugs in patients with advanced rare solid tumours with corresponding actionable alterations, as well as the safety and efficacy of immune checkpoint (programmed death receptor inhibitor 1, PD-1) inhibitors in patients with advanced rare solid tumours without actionable alterations. Patients with advanced rare tumours who fail standardised treatment and carry actionable alterations (Epidermal growth factor receptor (EGFR) mutations, ALK gene fusions, ROS-1 gene fusions, C-MET gene amplifications/mutations, BRAF mutations, CDKN2A mutations, BRCA1/2 mutations, HER-2 mutations/overexpressions/amplifications or C-KIT mutations) will be enrolled in the targeted therapy arm and be given the corresponding targeted drugs. Patients without actionable alterations will be enrolled in the PD-1 inhibitor arm and be treated with sintilimab. After the patients treated with vemurafenib, niraparib and palbociclib acquire resistance, they will receive combination treatment with sintilimab or atezolizumab. With the use of Simon’s two-stage Minimax design, and the sample size was estimated to be 770. The primary endpoint of this study is the objective response rate. The secondary endpoints are progression-free survival in the targeted treatment group and single-agent immunotherapy group; the duration of response in the targeted therapy and single-agent immunotherapy groups; durable clinical benefit in the single-agent immunotherapy group; and the incidence of adverse events.Ethics and disseminationEthics approval was obtained from the Chinese Academy of Medical Sciences (ID: 20/132-2328). The results from this study will be actively disseminated through manuscript publications and conference presentations.Trial registration numbersNCT04423185; ChiCTR2000039310.

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