ScienHub and Its Key Role in the SUPERNOVA Study on Preventive Monoclonal Antibodies Against COVID-19
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SUPERNOVA study evaluates the efficacy of preventive monoclonal antibodies against SARS-CoV-2 in patients with antibody synthesis deficiencies, whether due to primary causes or secondary to biological or immunosuppressive treatments.
ScienHub’s contribution to this study has been essential, as it was responsible for coordinating and executing all procedures, as well as conducting thorough follow-ups over the course of a year through weekly phone calls to assess the onset of COVID-19 symptoms in enrolled patients. With 30 participating patients, our center was the second most active hospital in Spain in terms of participation.
Approval of Sipavibart
Recently, AstraZeneca announced the approval of sipavibart (AZD3152) in Europe and Japan for the prevention of symptomatic COVID-19 in immunocompromised populations, based on the results of the SUPERNOVA study.
These findings reinforce ScienHub’s crucial role in advancing preventive strategies for vulnerable populations and highlight the importance of clinical research in the fight against COVID-19.
ScienHub Research Support Develops the Thalassa 2.0 Trial for Long COVID
The Fights Infections Foundation and PharmaMar have launched the Thalassa 2.0 trial to evaluate the efficacy of plitidepsin in patients with long COVID. ScienHub Research Support will oversee the study’s execution with patients from the Hospital Universitari Germans Trias i Pujol, in collaboration with IrsiCaixa.
The phase II study will include 90 patients divided into three groups: one will receive plitidepsin in four cycles, another will receive two cycles of placebo followed by two of plitidepsin, and the third will receive only a placebo.
Primary objective: Assess health changes using the PROMIS-29® system.
Secondary objective: Analyze the safety and tolerability of plitidepsin.
This project strengthens ScienHub’s commitment to researching innovative treatments.
Launch of Soc Recerca: the new platform that connects volunteers with clinical trials
We are pleased to announce the launch of Soc Recerca, the ScienHub Research Support platform designed to recruit volunteers interested in participating in clinical trials. Its mission is to drive clinical medical research and contribute to the advancement of global health.
The importance of Soc Recerca lies in its ability to accelerate the recruitment of volunteers, a crucial factor for the success of clinical trials. The platform not only informs participants about the objectives of each study but also enables a more organized and efficient selection process, fostering more inclusive and participatory research.
The AEMPS publishes a guide for decentralized clinical trials
The Spanish Agency of Medicines and Medical Devices (AEMPS) has published the Guide for the Implementation of Decentralized Elements in Clinical Trials. This document, created by a multidisciplinary group coordinated by the AEMPS, addresses the increasing use of digital tools in clinical trials. It also complements the European 2022 guide, tackling aspects that were open to interpretation depending on the legislation of each member state. Both guides aim to provide clear recommendations for procedures carried out outside trial centers, ensuring data reliability and facilitating regulatory decision-making.
Decentralized clinical trials (DCTs) bring studies closer to patients through technologies such as telemedicine, virtual recruitment, electronic consent, and mobile nursing. This model helps involve people facing barriers such as distance, limited mobility, or lack of availability to travel.
During the COVID-19 pandemic, ScienHub successfully implemented home-based CTUs, adapting to patients’ needs. We continue to offer these solutions today to ensure the continuity of trials.
The document will be officially presented during the first quarter of 2025 in a discussion held at the AEMPS headquarters. The event will also be available for streaming.
Favorable results in the audit of the IMMUNOCORE study on HIV treatment
As part of the IMMUNOCORE study, led by Dr. Bea Mothe and Aroa Nieto as Study Coordinator at ScienHub Research Support, a sponsor audit has been carried out with very positive results. The audit committee highlighted the quality of the work carried out and congratulated the team for its excellent management and execution of the study.
IMMUNOCORE’s study is a phase I/II study evaluating the safety, pharmacokinetics and antiviral activity of a new treatment for patients with chronic HIV infection. Tasks performed by team members include trial coordination, performing protocol procedures, data entry, and participant follow-up.
These positive assessments reflect the solidity and quality of the work of the ScienHub Research Support CTU team, made up of more than 20 professionals highly specialized in the implementation of clinical studies.