Safety Evaluation and Tolerability Overview of Favipiravir in the Management of COVID-19: A Real-Life Experience from Turkey

Introduction: Coronavirus diseases-2019 (COVID-19) have been ongoing for more than two years. Despite the scientific researchconducted in this process, there is still no widely accepted definitive treatment for the disease. For treating COVID-19, using antiviralagents previously used for the treatment of other RNA-virus infections has been seen as a fast way to a solution, and favipiravir is oneof the leading agents. This prospective, multicenter, observational study was designed to investigate the safety of favipiravir in 500patients treated with favipravir for favipravir.Methods: This study was conducted as a multicenter prospective study. Eight different sites from four cities participated, and 500patients were included in the study. Follow-up of laboratory parameters, adverse events (AEs), and amelioration of fever, dyspnea,and cough symptoms of the patients was recorded in a case report form.Results: A total of 475 patients from eight centers completed the study. A total of 401 AEs were reported in 206 (51.4%) patients, whichwere mild-to-moderate in the majority of cases. Serious AEs occurred in 5 patients and death occurred in 4 patients. From the first tothe last measurement, serum alanine aminotransferase levels (31.9±27.7 vs. 47.2±49.7 U/L, p&lt;0.001) increased, whereas C-reactiveprotein (39.9±66.4 vs. 15.2±30.5 mg/L, p&lt;0.001) and creatine kinase (101.7±187.7 vs. 71.9±43.5 U/L, p=0.018) levels decreased. Infollow-up parameters, oxygen saturation (SpO2; 96.2±2.7 vs. 97.5±2.1%, p&lt;0.001) and amelioration of fever (&gt;37.8 for 6.6% on day 3,3.2% on day 5, and 0.6% on day 10), dyspnea (for 56.4% on day 5, 62.4% on day 7, and 81.2% on day 10), and cough (46.0% on day 5,73.0% on day 7, and 87.3% on day 10) were noted in an increasingly higher percentage of patients with continued therapy.Conclusion: The current study provides real-life data of favipiravir, which is a unique option in Turkey for treating COVID-19 patients.The results revealed that favipiravir is a well-tolerated agent with a low side-effect profile. However, it needs to be evaluated withwell-designed, dose-compared, randomized controlled studies for the evaluation of efficacy</p

An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial

Background: There is an increasing need to organize the care around the patient and not the disease, while considering the complex realities of multiple physical and psychosocial conditions, and polypharmacy. Integrated patient-centered care delivery platforms have been developed for both patients and clinicians. These platforms could provide a promising way to achieve a collaborative environment that improves the provision of integrated care for patients via enhanced information and communication technology solutions for semiautomated clinical decision support. Objective: The Collaborative Care and Cure Cloud project (C3-Cloud) has developed 2 collaborative computer platforms for patients and members of the multidisciplinary team (MDT) and deployed these in 3 different European settings. The objective of this study is to pilot test the platforms and evaluate their impact on patients with 2 or more chronic conditions (diabetes mellitus type 2, heart failure, kidney failure, depression), their informal caregivers, health care professionals, and, to some extent, health care systems. Methods: This paper describes the protocol for conducting an evaluation of user experience, acceptability, and usefulness of the platforms. For this, 2 “testing and evaluation” phases have been defined, involving multiple qualitative methods (focus groups and surveys) and advanced impact modeling (predictive modeling and cost-benefit analysis). Patients and health care professionals were identified and recruited from 3 partnering regions in Spain, Sweden, and the United Kingdom via electronic health record screening. Results: The technology trial in this 4-year funded project (2016-2020) concluded in April 2020. The pilot technology trial for evaluation phases 3 and 4 was launched in November 2019 and carried out until April 2020. Data collection for these phases is completed with promising results on platform acceptance and socioeconomic impact. We believe that the phased, iterative approach taken is useful as it involves relevant stakeholders at crucial stages in the platform development and allows for a sound user acceptance assessment of the final product. Conclusions: Patients with multiple chronic conditions often experience shortcomings in the care they receive. It is hoped that personalized care plan platforms for patients and collaboration platforms for members of MDTs can help tackle the specific challenges of clinical guideline reconciliation for patients with multimorbidity and improve the management of polypharmacy. The initial evaluative phases have indicated promising results of platform usability. Results of phases 3 and 4 were methodologically useful, yet limited due to the COVID-19 pandemic