SAN FRANCISCO, December 3, 2021 / PRNewswire / – Today, Quantum Leap Healthcare Collaborative (QLHC), sponsor of the COVID I-SPY trial, announced that the IC14 portion of the trial has been completed. This decision was due to the high likelihood that IC14 would not have a significant impact on shortening recovery time or mortality in critically ill patients with COVID-19.
IC14 is a chimeric monoclonal antibody which was selected for inclusion in the assay because targeting CD14 may be an appropriate strategy to modulate the host’s innate immune response which causes severe disease and organ damage in the disease. COVID-19. The IC14 test was stopped on the recommendation of the Data Monitoring Committee (DMC) after 66 subjects were randomized to the IC14 arm and analyzed in the intention-to-treat (ITT) population. Patients assigned to the IC14 arm received maintenance therapy, comprising dexamethasone and remdesivir, plus 4 mg / kg IC14 by intravenous infusion on day 1 and 2 mg / kg on days 2, 3 and 4.
The IC14 results were compared to 76 subjects who were simultaneously randomized to the spine control arm. The graduation criteria were not met, but the futility criteria were partially met. The probability that IC14 can reduce recovery time has been estimated to be 3.4%; the probability that the IC14 arm is superior to the concomitant arm in reducing mortality was estimated at 62%. After all patients reached 28 days of follow-up, the data suggested that there was a low likelihood that adding IC14 to back therapy would have an impact on time to recovery or mortality.
Garry Redlich, CEO of Implicit Bioscience, owner of the IC14 development program, said: “We are very grateful for the opportunity offered by QLHC to participate in their courageous mission to identify a revolutionary intervention in the advanced stages of this very difficult disease. . Our interaction with the I – The SPY COVID Trial Leadership Team has been inspiring. Other clinical and research collaborations testing IC14 in less sick COVID-19 patients are underway. Our core clinical portfolio in neurology, cardiology and ophthalmology remains the main focus of the company “
Dr. Laura Esserman, Co-Principal Investigator of the COVID I-SPY Trial commented, “We are grateful for the partnership with Implicit Bioscience. Critically ill patients with viral pneumonia are very difficult to treat and there are few options that really impact the results. We have not seen a significant impact with IC14 in our COVID-19 patients, but certainly cannot rule out that this agent may make a difference in non-COVID ARDS. “
The COVID I-SPY trial was designed to rapidly screen for agents showing promise for reducing recovery time (defined as reduced oxygen demand) or risk of death in critically ill COVID-19 patients. The study uses QLHC’s adaptive platform assay design methodology, which focuses on the simultaneous and efficient evaluation of multiple experimental agents. Previous agents evaluated in the trial include cenicriviroc, razuprotafib, apremilast, icatibant, and famotidine plus celecoxib. An investigational agent arm is recommended for discontinuation due to futility if improvement in recovery or mortality is insufficient. Specifically, the following futility rules apply:
- The treatment exceeds the 90% probability that the risk-benefit rate in recovery time is less than 1.5 compared to standard treatment (Pr (HR <1.5) 0.9)
- The posterior probability of its risk ratio for overall mortality relative to the spine (adjusted for baseline COVID-19 level status) is greater than one is greater than or equal to 0.5 (Pr (HRmortality > 1) 0.5).
IC14 was administered at 24 participating US sites. There were no safety issues associated with IC14 in the trial.
Investigation of other agents via COVID I-SPY trial ongoing, investigators continue to rapidly screen for treatments to identify highly effective therapies; this remains an urgent priority for QLHC and its partners. The I-SPY COVID trial now includes 24 sites as well as leaders in pulmonary and critical care centers across the country.
The I-SPY COVID trial is a collaboration between members of Quantum Leap, pharmaceutical partners such as Implicit Bioscience and United States government. This work is supported in part by the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary of Preparedness and Response within the US Department of Health and Human Services, and the executive office of the joint program of the Ministry of Defense for Chemical, Biological, Radiological and Nuclear Defense, in collaboration with the Consortium for Medical, Chemical, Biological, Radiological and Nuclear Defense (MCDC) – (contract MCDC2014-001). The Defense Threat Reduction Agency (DTRA) enables the Department of Defense (DoD), the US government and international partners to counter and deter weapons of mass destruction (WMD) and emerging threats.
About Quantum Leap Healthcare Collaborative
??Quantum Leap Healthcare Collaborative is a 501C (3) charitable organization established in 2005 as a collaboration between medical researchers from University of California, San Francisco and entrepreneurs from Silicon Valley. Our mission is to integrate high impact research into clinical processes and systems technology, which translates into improved data management and information systems, better access to clinical trial matching and sponsorship, and greater benefit for providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial and regulatory oversight of I-SPY trials. For more information visit www.QuantumLeapHealth.org.
About the I-SPY COVID trial
The I-SPY COVID (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) trial is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and the time required to evaluate the experimental and / or reused tests. medications. The aim of the trial is to improve outcomes for critically ill COVID-19 patients – those who need at least 6 L of high-flow oxygen either by mask or nasal cannula, known as Level 5 name on the World Health Organization (WHO) COVID Scale, an 8-point ordinal scale of clinical severity status. Primary endpoints include the time it takes to reach level 4 or below for at least 48 hours on the WHO COVID scale, decreased duration of ventilator use, and decreased mortality .
The COVID I-SPY trial is sponsored and managed by Quantum Leap Healthcare Collaborative. For more information visit www.quantumleaphealth.org Where www.ispytrials.org.
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SOURCE Quantum Leap Collaboration for Healthcare