STRIVE: (Strategies and Treatments for Respiratory Infections & Viral Emergencies; INSIGHT 018) This Study aims to provide an agile research platform able to investigate strategies and treatments that may improve the health of patients hospitalized with a respiratory infection. The master protocol defines the scientific and operational framework of trials implemented as part of the platform. The specific design and conduct of each trial are described in trial-specific appendices. This approach is intended to pre-position infrastructure and to facilitate rapid and flexible response with high standards of scientific rigor to support the development of consensus for standard of care.
OTAC: Is an International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. The purpose of this study is to compare safety and efficacy of a single infusion of anti-COVID-19 hyperimmune Intravenous Immunoglobulin (hIVIG) versus placebo in adults with recently diagnosed SARS-CoV-2 infection who do not require hospitalization. This study is a collaboration of INSIGHT and the Division of Clinical Research (DRC) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH).
Our role in these two studies is to identify potential eligible subjects from Herlev & Gentofte Hospital. When we are able to identify eligible subjects, we plan and execute the trial, procedures and visit according to protocol.