STRIVE Network Clinical Coordinating Center
Director: Jason V. Baker, MD, MS
STRIVE (Strategies and Treatments for Respiratory Infections and Viral Emergencies) is a global clinical research consortium aimed at improving the clinical outcomes of patients with infections while being prepared to respond to infectious disease emergencies, through the rapid implementation of clinical trials designed to inform practice guidelines, public health policy, and the delivery of health care. The STRIVE network focuses on designing, implementing, and delivering the highest quality clinical research, from observational studies through randomized trials implemented globally. The Hennepin international coordinating center (HENN-ICC) is one of nine ICCs within the STRIVE network, and our team oversees the conduct of study protocols at over 20 clinical sites within the U.S. and 4 clinical sites within Mexico.
Studies
STRIVE Trial #1: Ensitrelvir
This is a COVID-19 randomized clinical trial designed to evaluate the safety and efficacy of ensitrelvir (S-217622), an anti-SARS-CoV-2 3C-like protease inhibitor developed by Shionogi & Co. Ltd, when given in addition to standard of care in patients hospitalized for medical management of COVID-19. The primary efficacy outcome will assess clinical recovery over 60 days. Participants will be randomized to receive a 5-day course of oral ensitrelvir or a 5-day course of matching oral placebo in addition to standard of care. The planned sample size is 1500 participants, enrolled over ~200 clinical sites globally.
STRIVE Trial #2: Early Immunomodulatory Intensification with Abatacept
This is a COVID-19 randomized clinical trial designed to evaluate the safety and efficacy of adding a second immune modulator abatacept on top of a baseline therapy of a single immune modulator in participants hospitalized with COVID-19 and on conventional supplementary oxygen. Participants will be randomized to receive a one-time infusion of abatacept or matching placebo. The primary efficacy outcome will assess clinical recovery over 60 days of follow-up. The planned sample size is 1500 participants, enrolled over ~150 clinical sites globally.
OTAC: outpatient treatment with anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG)
This is a COVID-19 randomized clinical trial designed to evaluate the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune Intravenous Immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed SARS-CoV-2 infection who do not require hospitalization. The planned sample size is 820 participants, enrolled at over 50 clinical sites globally.
STRIVE Trial #3: Steroid Treatment for Severe Acute Respiratory Infection (STAR) Trial
This is a randomized trial comparing systemic corticosteroids vs no systemic corticosteroids among hospitalized patients with severe acute respiratory infection (SARI) and hypoxemia, with a primary clinical outcome defined by a composite endpoint of death, duration of advanced respiratory support, and duration of hospitalization. The STAR trial will enroll 4,000 adults across approximately 200 clinical centers within the STRIVE global trial network.
IC-SARI: severe acute respiratory syndrome in immunocompromised hosts
'Study under development'
Dengue Trial
'Study under development'
Key Investigators
