Webinar on

Clinical Trials

April 26, 2021

Scientific Program

Keynote Session:

Oral Session 1:

  • Pre-clinical Research
Meetings International -  Conference Keynote Speaker Prabhat Adhikari photo

Prabhat Adhikari

Nepal Health Research Council, Nepal

Title: Efficacy of favipiravir in treatment of mild & moderate COVID-19 infection in Nepal: a multi-center, randomized, open-labelled, phase III clinical trial

Biography:

Prabhat Adhikari, MD is an internal medicine, infectious disease and critical care physician who has been practicing in both Nepal and the USA. Besides his clinical practice, Dr Adhikari has been leading some research projects in Nepal, mostly in the field of Infectious Diseases & ICU. He has special interest in AMR, TB, COVID-19, HIV & ARDS among others. Dr Adhikari has also collaboratively established a medical IT company called Danphe Care, where he blends his medical expertise with cutting edge technologies to create healthcare solutions to meet the needs of low- and middle-income countries. Recently he is working on developing an “electronic health record” medical software system & manufacturing medical ventilators, especially during the COVID-19 crisis. Dr. Adhikari has been providing healthcare services to the underprivileged population of Nepal through the ASK Foundation, a not-for-profit organization.

Abstract:

Problem Statement: The pandemic of COVID-19 has been a global public health emergency, with not a single antiviral drug being approved for treatment so far, except for Remdesivir. We sought to evaluate the efficacy of repurposed use of Favipiravir in the clinical outcomes of mild and moderate COVID-19 cases in Nepal.

Methods: We conducted a multicenter, randomized (1:1), open labeled, phase III clinical trial among adults diagnosed with mild to moderate COVID-19 infections, as an inpatient or outpatient basis. Patients with mild symptoms were randomly assigned to receive Favipiravir (study regimen: oral form, 1800 mg twice on Day1 and then 800mg twice daily for 5 days) or matching placebo. Those with moderate symptoms were randomly allocated to receive either Favipiravir (study regimen for 10 days) or intravenous Remdesivir (200mg on Day 1, followed by 100mg once daily for 5days). The primary outcome was to evaluate for clinical improvement among both the cohorts based on treatment received. Here, we report an interim safety and efficacy analysis of the study.

Results: Between January 2021 to March 2021, a total of 90 cases (Mild: 70, Moderate: 20) with 61% being male, were enrolled from 8 different centers. The result of analysis on clinical efficacy has been as reported in the table submitted herewith. There was one minor event of increment in uric acid level and two events of elevated liver enzymes observed, however none of the adverse events required any hospital admissions or special intervention.

Conclusion: We conclude that Favipiravir has an excellent safety profile but we need to achieve a bigger sample size in order to evaluate for any possible efficacy in treatment of mild & moderate COVID-19 cases.

Keynote Session:

Oral Session 1:

  • Clinical Trials on Different Diseases
Meetings International -  Conference Keynote Speaker Heinz-Peter Schultheiss photo

Heinz-Peter Schultheiss

Institute for Cardiac Diagnostics and Therapy, Germany

Title: Transcriptional active parvovirus B19 infection and intramyocardial inflammation predict adverse long-term mortality in a large cohort of patients with inflammatory cardiomyopathy

Biography:

Heinz-Peter Schultheiss, Alida L. Caforio, Felicitas Escher, DeLisa L. Fairweather, Ray E. Hershberger, Steven E. Lipshultz, Peter P. Liu, Akira Matsumori, Andrea Mazzanti, John McMurray, Silvia G. Priori. Dilated cardiomyopathy. Nature Reviews Dis Primers 2019 May 9;5(1):32. The ESC Textbook of Cardiovascular Medicine, Third Edition, 2019. Chapter 32.21: Myocarditis - Treatment of myocarditis, Heinz-Peter Schultheiss and Felicitas Escher. Pietsch, H., Escher, F., Aleshcheva, G., Lassner, D., Bock, C.T., Schultheiss, H.P. Detection of parvovirus mRNAs as markers for viral activity in endomyocardial biopsy-based diagnosis of patients with unexplained heart failure. Sci Rep. 2020;10(1):22354.

Abstract:

Parvovirus B19 (B19V) is the predominant cardiotropic virus found in endomyocardial biopsies (EMBs). Nevertheless, direct evidence showing a causal relationship between B19V cardiac presence and disease progression of B19V‐associated dilated inflammatory cardiomyopathy (DCMi) were still missing. Parvovirus B19 NS1 and VP1/2 mRNA expression indicates viral activity. Aim of this study was - To established qRT-PCR to detect B19V viral RNA of capsid (VP1) and non-structural (NS1) sequences - to analyse the influence of actively replicating B19V and inflammation upon long-term mortality in a large cohort of adult patients with inflammatory cardiomyopathy. The study group comprised 871 consecutive B19V-positive patients (mean ejection fraction (LVEF) =48.6±20.0%) who underwent EMB after exclusion of ischemic or valvular heart disease. EMB analysis confirmed inflammation in 436 (50.1%) B19V-positive patients. The patients were followed for 60 months. Information on vital status was obtained from official resident data files. Patients with inflammation and replicative active B19V infection revealed the poorest prognosis compared to patients without/with inflammation without B19V replicative intermediates (p=0.0002/p=0.045). Viral load had no significant influence on the patient’s outcome (p=0.079), contrary to inflammation (p=0.028) and replicative status (0.034).

Conclusion: This is the first study investigating the pathogenic clinical importance of B19V in a large cohort of patients. Transcriptional active cardiotropic B19V infection with positive replication intermediates and inflammation are unfavourable prognostic triggers of adverse long term-mortality, whereas B19 virus genomes without transcriptional activity has no effect on mortality. Our findings are of high clinical relevance, as they indicate for the first time that a selection of specific characterized B19V positive patients may profit from innovative tailored anti-viral immunomodulatory treatment strategies.

Oral Session 2:

  • Innovations in Clinical Trials
Meetings International -  Conference Keynote Speaker Fatima Yousef Ali Ghethan photo

Fatima Yousef Ali Ghethan

King Abdullah Medical City, Saudi Arabia

Title: The impact of using total quality management methodology for organization medication safety

Biography:

Fatima Yousef Ali Ghethan, Master degree pharmacology Head of Quality and Medication safety Department King Abdullah Medical City, Certified Medication Safety Officer from AIHQ USA, Certified key Performance Indicator Professional From KPI Institute Australia, Certified key Performance Indicator Practitioner From KPI Institute Australia, certificate Patient safety Program John’s Hopkins

Abstract:

The Institute of Medicine’s (IOM) first Quality Chasm report, To Err Is Human: Building a Safer Health System,1 stated that medication-related errors (a subset of medical error) were a significant cause of morbidity and mortality; they accounted “for one out of every 131 outpatient deaths, and one out of 854 inpatient deaths”1 (p. 27). Medication errors were estimated to account for more than 7,000 deaths annually.1 Building on this work and previous IOM reports, the IOM put forth a report in 2007 on medication safety, Preventing Medication Errors.2 This report emphasized the importance of severely reducing medication errors, improving communication with patients, continually monitoring for errors, providing clinicians with decision-support and information tools, and improving and standardizing medication labeling and drug-related information. Whereas one of the predominant causes of medication errors is a drug administration error, a previous study related to our investigations and reviews estimated that the incidences of medication errors constituted 6.7 out of 100 administrated medication doses. Therefore, we aimed by using six sigma approach to propose a way that reduces these errors to become less than 1 out of 100 administrated medication doses by improving healthcare professional education and clearer handwritten prescriptions.