scholarly journals Conducting a VR Clinical Trial in the Era of COVID-19

2021 ◽  
Vol 2 ◽  
Author(s):  
Joy Stradford ◽  
Ashwin Sakhare ◽  
Roshan Ravichandran ◽  
E. Todd Schroeder ◽  
Lori A. Michener ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Virtual Reality ◽  
Case Series ◽  
Transmission Risk ◽  
World Health ◽  
Global Public Health ◽  
Clinical Trial Research ◽  
Study Staff ◽  
Health Organization

The outbreak of severe acute respiratory syndrome coronavirus 2, also known as Coronavirus Disease 2019 (COVID-19) sparked a global public health pandemic that has impacted every aspect of daily life. Medical research was affected, and many clinical trials were halted to minimize COVID-19 transmission risk and spread while the world navigated this novel virus. Here we describe the relaunch of our virtual reality (VR) pilot clinical trial that uses an in-lab brain and body training program to promote brain health in mid-to-late life older adults, in the era of COVID-19. This case series includes five healthy female participants between 51 and 76 years of age, a subset of a larger VR pilot clinical trial that started pre-pandemic. We developed a revised study protocol based on the Center for Disease Control and World Health Organization guidelines to help manage the spread of COVID-19. Since the limited resumption of clinical trials at our institution in August 2020, we successfully completed over 200 in-lab virtual reality training sessions using our revised protocol. During this time, none of the five participants or three study staff reported any COVID-19 symptoms or reported a positive COVID-19 test. More than 40 voluntary COVID-19 tests were completed by our study staff over the last 6 months. All participants rated our safety protocol as very satisfied or extremely satisfied and that they would be very likely or extremely likely to participate in a VR clinical trial during the pandemic. Based on these findings, we suggest that continued VR clinical trial research during the COVID-19 pandemic is achievable and can be safely resumed if specific safety protocols are in place to mitigate the risk of exposure and spread of COVID-19.

scholarly journals Therapeutic Effectiveness and Safety of Repurposing Drugs for the Treatment of COVID-19: Position Standing in 2021

2021 ◽  
Vol 12 ◽  
Author(s):  
Safaet Alam ◽  
Taslima Binte Kamal ◽  
Md. Moklesur Rahman Sarker ◽  
Jin-Rong Zhou ◽  
S. M. Abdur Rahman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Series ◽  
Basic Knowledge ◽  
World Health ◽  
Current Status ◽  
Drug Candidates ◽  
Health Organization ◽  
Meta Analyses

COVID-19, transmitted by SARS-CoV-2, is one of the most serious pandemic situations in the history of mankind, and has already infected a huge population across the globe. This horrendously contagious viral outbreak was first identified in China and within a very short time it affected the world's health, transport, economic, and academic sectors. Despite the recent approval of a few anti-COVID-19 vaccines, their unavailability and insufficiency along with the lack of other potential therapeutic options are continuing to worsen the situation, with valuable lives continuing to be lost. In this situation, researchers across the globe are focusing on repurposing prospective drugs and prophylaxis such as favipiravir, remdesivir, chloroquine, hydroxychloroquine, ivermectin, lopinavir-ritonavir, azithromycin, doxycycline, ACEIs/ARBs, rivaroxaban, and protease inhibitors, which were preliminarily based on in vitro and in vivo pharmacological and toxicological study reports followed by clinical applications. Based on available preliminary data derived from limited clinical trials, the US National Institute of Health (NIH) and USFDA also recommended a few drugs to be repurposed i.e., hydroxychloroquine, remdesivir, and favipiravir. However, World Health Organization later recommended against the use of chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir in the treatment of COVID-19 infections. Combining basic knowledge of viral pathogenesis and pharmacodynamics of drug molecules as well as in silico approaches, many drug candidates have been investigated in clinical trials, some of which have been proven to be partially effective against COVID-19, and many of the other drugs are currently under extensive screening. The repurposing of prospective drug candidates from different stages of evaluation can be a handy wellspring in COVID-19 management and treatment along with approved anti-COVID-19 vaccines. This review article combined the information from completed clinical trials, case series, cohort studies, meta-analyses, and retrospective studies to focus on the current status of repurposing drugs in 2021.

scholarly journals Vaccines and Treatment of Coronavirus Disease 2019

2020 ◽  
Vol 95 (6) ◽  
pp. 364-369
Author(s):  
Pyoeng Gyun Choe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Antiviral Agents ◽  
World Health ◽  
Rna Dependent Rna Polymerase ◽  
Global Pandemic ◽  
The World ◽  
Polymerase Inhibitor ◽  
Experimental Treatments ◽  
Health Organization

In December 2019, a new strain of betacoronavirus, severe acute respiratory syndrome coronavirus 2, which causes coronavirus disease 2019 (COVID-19), emerged in Wuhan, China. Subsequently, the virus quickly spread worldwide and the World Health Organization declared COVID-19 a global pandemic on March 11, 2020. In response to the pandemic, many researchers are working on repurposing existing drugs to alter the course of severe COVID-19, and are testing experimental treatments. Among antiviral agents, remdesivir, an RNA-dependent RNA polymerase inhibitor, showed clinical benefit in a randomized clinical trial. In October 2020, the Food and Drug Administration approved remdesivir for treating hospitalized patients with COVID-19, making it the first drug approved for the disease. The race to produce safe, effective vaccines is also progressing at unprecedented speed, with over 200 under development and 45 candidates already being tested in human clinical trials (as of October 2020).

Remdesivir (GS-5734) in COVID-19 Therapy: The Fourth Chance

2020 ◽  
Vol 21 ◽  
Author(s):  
Dinesh Singh Moirangthem ◽  
Laishram Surbala
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Severe Acute Respiratory Syndrome ◽  
Mechanism Of Action ◽  
World Health ◽  
Viral Agent ◽  
Compassionate Use ◽  
Rna Dependent Rna Polymerase ◽  
Nucleotide Analog ◽  
Health Organization

Background: Since its initial start on December 2019 at Wuhan, China, the coronavirus disease 2019 (COVID19) has been rapidly spreading and labelled as pandemic by World Health Organization. The rate of human to human transmission of COVID-19 is far higher than severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome coronavirus (MERS). With no drugs or vaccines approved for the treatment of the disease, physicians have been using the pre-existing drugs to curb the disease. One potential anti-viral agent currently undergoing numerous clinical trial is remdesivir, a nucleotide analog that inhibits RNA-dependent RNA polymerase of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objective: In this mini-review, we provide an overview of remdesivir’s journey, mechanism of action, pharmacokinetics, used in patients with COVID-19 under compassionate use principle and clinical trials to understand the effect of remdesivir in the treatment of patients with COVID-19. Conclusion: In this mini-review, we provide an overview of remdesivir’s journey, mechanism of action, pharmacokinetics, used in patients with COVID-19 under compassionate use principle and clinical trials to understand the effect of remdesivir in the treatment of patients with COVID-19.

scholarly journals Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sarai Mirjam Keestra ◽  
Florence Rodgers ◽  
Daphne Lenz ◽  
Rhiannon Osborne ◽  
Till Bruckner ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Median Number ◽  
World Health ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Link Type ◽  
The Us ◽  
Health Organization ◽  
The Uk

AbstractClinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017–2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trials-tracker.com) for clinical trials registered on ClinicalTrials.gov. This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov. The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov: (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions’ reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.

scholarly journals Traditional Herbal Medicines, Bioactive Metabolites, and Plant Products Against COVID-19: Update on Clinical Trials and Mechanism of Actions

2021 ◽  
Vol 12 ◽  
Author(s):  
Safaet Alam ◽  
Md. Moklesur Rahman Sarker ◽  
Sadia Afrin ◽  
Fahmida Tasnim Richi ◽  
Chao Zhao ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Sector ◽  
Herbal Medicines ◽  
World Health ◽  
Bioactive Metabolites ◽  
High Morbidity ◽  
Global Public Health ◽  
Traditional Medicines ◽  
The World ◽  
Health Organization

SARS-CoV-2 is the latest worldwide pandemic declared by the World Health Organization and there is no established anti-COVID-19 drug to combat this notorious situation except some recently approved vaccines. By affecting the global public health sector, this viral infection has created a disastrous situation associated with high morbidity and mortality rates along with remarkable cases of hospitalization because of its tendency to be high infective. These challenges forced researchers and leading pharmaceutical companies to find and develop cures for this novel strain of coronavirus. Besides, plants have a proven history of being notable wellsprings of potential drugs, including antiviral, antibacterial, and anticancer therapies. As a continuation of this approach, plant-based preparations and bioactive metabolites along with a notable number of traditional medicines, bioactive phytochemicals, traditional Chinese medicines, nutraceuticals, Ayurvedic preparations, and other plant-based products are being explored as possible therapeutics against COVID-19. Moreover, the unavailability of effective medicines against COVID-19 has driven researchers and members of the pharmaceutical, herbal, and related industries to conduct extensive investigations of plant-based products, especially those that have already shown antiviral properties. Even the recent invention of several vaccines has not eliminated doubts about safety and efficacy. As a consequence, many limited, unregulated clinical trials involving conventional mono- and poly-herbal therapies are being conducted in various areas of the world. Of the many clinical trials to establish such agents as credentialed sources of anti-COVID-19 medications, only a few have reached the landmark of completion. In this review, we have highlighted and focused on plant-based anti-COVID-19 clinical trials found in several scientific and authenticated databases. The aim is to allow researchers and innovators to identify promising and prospective anti-COVID-19 agents in clinical trials (either completed or recruiting) to establish them as novel therapies to address this unwanted pandemic.

High-dose or multi-day praziquantel for imported schistosomiasis? A systematic review

2019 ◽  
Vol 26 (7) ◽  
Author(s):  
Giulia Cucchetto ◽  
Dora Buonfrate ◽  
Valentina Marchese ◽  
Paola Rodari ◽  
Anna Ferrari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
World Health Organization ◽  
Case Reports ◽  
Case Series ◽  
Sub Saharan Africa ◽  
World Health ◽  
The World ◽  
Endemic Areas ◽  
Health Organization

Abstract Background Schistosomiasis affects more than 260 million people worldwide, mostly in sub-Saharan Africa, where more than 280 000 deaths per year are estimated. In the past few years, the increasing flow of migrants from endemic areas and the upward number of international travels have caused the emergence of the disease also in non-endemic areas. A single course of praziquantel (PZQ) 40 mg/kg is the first-line treatment recommended by the World Health Organization, mainly based on clinical trials conducted in endemic countries. No trials have been performed in non-endemic areas. Methods We carried out a systematic review of case reports and case series published between 1956 and August 2017 on cases of chronic schistosomiasis (infection acquired >3 months before) diagnosed in non-endemic areas and treated with PZQ. Primary outcome was to assess the number of different therapeutic regimens deployed and their frequency of use, calculated as the number of reports for each regimen over the total number of included cases. Results The final database included 99 case reports and 51 case series, for a total of 1433 patients. In 57 of the 150 records (38%) the administered treatment was different from the one recommended by the World Health Organization. The proportion of ‘alternative’ regimens included increased doses of PZQ (up to 80 mg/kg) and/or prolonged duration of treatment and/or doses repeated some days/weeks apart. About 50% of the records regarding Western short-term travellers reported a non-standard treatment. Conclusion This is the first complete catalogue of the published experience with PZQ outside of endemic areas in the situation where reinfection is not an issue. We found a wide heterogeneity of the therapeutic regimens reported. Multicenter clinical trials conducted in non-endemic areas and guidelines specifically addressing the treatment of imported cases of chronic schistosomiasis are needed.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

scholarly journals World Health Report on Vision: Aging Implications for Global Vision and Eye Health

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 807-808
Author(s):  
Bonnielin Swenor ◽  
Varshini Varadaraj ◽  
Moon Jeong Lee ◽  
Heather Whitson ◽  
Pradeep Ramulu
Keyword(s):  
Older Adults ◽  
Visual Impairment ◽  
Vision Loss ◽  
World Health ◽  
World Health Report ◽  
Global Public Health ◽  
Eye Care ◽  
Health Report ◽  
Public Health Challenges ◽  
Health Organization

Abstract In 2019, the World Health Organization World Report on Vision estimated that that 2.2 billion people have a vision impairment, of which almost half could have been prevented or is yet to be addressed. As the global population ages and the prevalence of visual impairment increases, inequities in eye care and the downstream health and aging consequences of vision loss will become magnified. This session will: (1) provide key information regarding the burden of eye disease and visual impairment among older adults worldwide; (2) outline a framework created to conceptualize the aging and long-term health implications of vision loss, and (3) discuss the global public health challenges to eye care and to maximizing health for older adults with visual impairments.

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