Proof of Concept Clinical Trial of Bioimpedance-based NAFLD Diagnosis Technique

2021 ◽  
Author(s):  
Nina Gyorfi ◽  
Akos Odry ◽  
Zoltan Karadi ◽  
Peter Odry ◽  
Andras Vereczkei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Proof Of Concept ◽  
Diagnosis Technique

scholarly journals Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Iwein Gyselinck ◽  
◽  
Laurens Liesenborghs ◽  
Ewout Landeloos ◽  
Ann Belmans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Cytokine Signaling ◽  
Nasopharyngeal Swab ◽  
The Novel ◽  
Proof Of Concept ◽  
Open Label ◽  
Novel Coronavirus

Abstract Background The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory state leading to severe COVID-19 disease. Azithromycin is a macrolide antibiotic, known for its immunomodulatory properties. It has shown antiviral effect specifically against SARS-CoV-2 in vitro and acts on cytokine signaling pathways that have been implicated in COVID-19. Methods DAWn-AZITHRO is a randomized, open-label, phase 2 proof-of-concept, multicenter clinical trial, evaluating the safety and efficacy of azithromycin for treating hospitalized patients with COVID-19. It is part of a series of trials testing promising interventions for COVID-19, running in parallel and grouped under the name DAWn-studies. Patients hospitalized on dedicated COVID wards are eligible for study inclusion when they are symptomatic (i.e., clinical or radiological signs) and have been diagnosed with COVID-19 within the last 72 h through PCR (nasopharyngeal swab or bronchoalveolar lavage) or chest CT scan showing typical features of COVID-19 and without alternate diagnosis. Patients are block-randomized (9 patients) with a 2:1 allocation to receive azithromycin plus standard of care versus standard of care alone. Standard of care is mostly supportive, but may comprise hydroxychloroquine, up to the treating physician’s discretion and depending on local policy and national health regulations. The treatment group receives azithromycin qd 500 mg during the first 5 consecutive days after inclusion. The trial will include 284 patients and recruits from 15 centers across Belgium. The primary outcome is time from admission (day 0) to life discharge or to sustained clinical improvement, defined as an improvement of two points on the WHO 7-category ordinal scale sustained for at least 3 days. Discussion The trial investigates the urgent and still unmet global need for drugs that may impact the disease course of COVID-19. It will either provide support or else justify the discouragement of the current widespread, uncontrolled use of azithromycin in patients with COVID-19. The analogous design of other parallel trials of the DAWN consortium will amplify the chance of identifying successful treatment strategies and allow comparison of treatment effects within an identical clinical context. Trial registration EU Clinical trials register EudraCT Nb 2020-001614-38. Registered on 22 April 2020

scholarly journals Correction to: A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
T. Vanassche ◽  
◽  
M. M. Engelen ◽  
Q. Van Thillo ◽  
J. Wauters ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Proof Of Concept ◽  
Open Label

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Veronica Swystun ◽  
Francis H. Y. Green ◽  
John H. Dennis ◽  
Emmanouil Rampakakis ◽  
Gurkeet Lalli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Acute Asthma ◽  
Proof Of Concept ◽  
Double Blind ◽  
New Class

scholarly journals ACTR-44. PRELIMINARY RESULTS FROM THE NCT02770378 PROOF-OF-CONCEPT CLINICAL TRIAL ASSESSING THE SAFETY OF THE CUSP9v3 PROTOCOL COMBINED WITH METRONOMIC TEMOZOLOMIDE FOR RECURRENT GLIOBLASTOMA

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi21-vi21
Author(s):  
Marc-Eric Halatsch ◽  
Richard Kast ◽  
Georg Karpel-Massler ◽  
Carl Schmidt ◽  
Birgit Schmelzle ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Recurrent Glioblastoma ◽  
Proof Of Concept ◽  
Preliminary Results

scholarly journals Hemophilia gene therapy: ushering in a new treatment paradigm?

Hematology ◽  
2021 ◽  
Vol 2021 (1) ◽  
pp. 226-233
Author(s):  
Lindsey A. George
Keyword(s):  
Clinical Trial ◽  
Gene Therapy ◽  
Clinical Trials ◽  
Hemophilia A ◽  
Full Potential ◽  
Proof Of Concept ◽  
Aav Vector ◽  
Treatment Paradigm ◽  
Clinical Trial Enrollment ◽  
New Treatment

Abstract After 3 decades of clinical trials, repeated proof-of-concept success has now been demonstrated in hemophilia A and B gene therapy. Current clinical hemophilia gene therapy efforts are largely focused on the use of systemically administered recombinant adeno-associated viral (rAAV) vectors for F8 or F9 gene addition. With multiple ongoing trials, including licensing studies in hemophilia A and B, many are cautiously optimistic that the first AAV vectors will obtain regulatory approval within approximately 1 year. While supported optimism suggests that the goal of gene therapy to alter the paradigm of hemophilia care may soon be realized, a number of outstanding questions have emerged from clinical trial that are in need of answers to harness the full potential of gene therapy for hemophilia patients. This article reviews the use of AAV vector gene addition approaches for hemophilia A and B, focusing specifically on information to review in the process of obtaining informed consent for hemophilia patients prior to clinical trial enrollment or administering a licensed AAV vector.

scholarly journals Blockchain protocols in clinical trials: Transparency and traceability of consent

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 66 ◽  
Author(s):  
Mehdi Benchoufi ◽  
Raphael Porcher ◽  
Philippe Ravaud
Keyword(s):  
Clinical Trial ◽  
Research Field ◽  
Point Of View ◽  
Complex Data ◽  
Proof Of Concept ◽  
Chronological Order ◽  
Blockchain Technology ◽  
Smart Contract ◽  
The Right ◽  
Core Functionality

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing the collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we will built a consent workflow using a rising technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. Additionally, it removes the need for third parties, and gives participative control to the peer-to-peer users. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain; thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each revision of the protocol, consent was sought again. We obtained a single document, in a standard open format, that accounted for the whole consent collection process: timestamped consent status with regards to each version of the protocol. This document cannot be corrupted, and can be checked on any dedicated public website. It should be considered as a robust proof of data. In the future, we think that the complex data flow of a clinical trial can be tracked using Blockchain. Moreover, a blockchain core functionality, named Smart Contract, can help prevent clinical trial events not to happen in the right chronological order: including patients before they consented or analysing case report forms data before freezing the database. This will help reaching reliability, security, and transparency, and could be a consistent step towards reproducibility.

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