Global platform study presents results to guide care of severely ill patients with COVID-19 using routinely available drugs – simvastatin and Vitamin COctober 25, 2023 | BUSINESSWIRE
The world’s largest trial of multiple interventions for critically ill adults with COVID-19 has simultaneously released results about two of its treatments, vitamin C and simvastatin.
LARKSPUR, Calif. & PITTSBURGH–(BUSINESS WIRE)–The Global Coalition for Adaptive Research (GCAR) in collaboration with the University of Pittsburgh and UPMC, on behalf of the REMAP-CAP Investigator Network, announce clinical trial results examining the use of vitamin C and simvastatin to treat severely ill patients with COVID-19.
Published today in JAMA and NEJM, and presented at the European Society of Intensive Care Medicine in Milan, the studies are part of the ongoing Randomized Embedded Multifactorial Adaptive Platform for Community Acquired Pneumonia (REMAP-CAP) trial.
Simvastatin, a widely available and inexpensive drug that is included on the WHO list of essential medicines, was shown to have a high probability (96%) of improving outcomes (a combination of survival and length of time patients need support in an intensive care unit) when started as a treatment for critically ill patients with COVID-19, and a 92% chance of improving survival at 3 months. This equates to one life saved for every 33 patients treated with simvastatin. 2684 critically ill patients were included at 141 hospitals across 13 countries.
“These results are really encouraging as they have shown that treatment with simvastatin is highly likely to improve outcomes in critically ill patients with COVID-19,” said Professor Danny McAuley, Professor and Consultant in Intensive Care Medicine at the Royal Victoria Hospital and Queen’s University Belfast and lead investigator for the Simvastatin Domain of REMAP-CAP. “This research will help healthcare professionals internationally to improve the treatment of patients with COVID-19.”
Vitamin C is widely available around the world and was used in some settings for the treatment of COVID-19. Through harmonizing two clinical trials – REMAP-CAP and LOVIT-COVID – over 2500 patients in 20 countries took part, including both critically ill and non-critically ill patients with COVID-19 in hospital. It was shown that high dose vitamin C did not improve outcomes for patients. This is the largest trial examining high-dose vitamin C in COVID-19 and provides evidence that high-dose vitamin C is not beneficial and suggests a high probability that it may be harmful.
“Harnessing the power of global collaboration, the harmonized REMAP-CAP and LOVIT-COVID trials have investigated vitamin C, a potential therapy for COVID-19, and have shown it to be ineffective and probably harmful,” said Dr. Neill Adhikari, co-lead investigator for the LOVIT-COVID trial and of the Vitamin C Domain of REMAP-CAP. “The results from this trial suggest that the use of vitamin C in hospitalised COVID-19 patients should be de-adopted.” Dr. François Lamontagne, co-lead investigator of these trials, added, “The results underscore the health and economic benefits of identifying and abandoning readily available interventions that are ineffective and potentially harmful to patients.”
Through this global initiative, combining clinical trial data and recruiting patients from countries around the world, this model of research continues to produce important evidence for the clinical communities.
“The beauty of these trials is in connecting doctors across continents to provide the best possible treatment for the sickest patients with COVID-19, while learning from each other to arrive at evidence-based answers to improve standard of care for patients worldwide,” said Derek Angus, MD, MPH, FRCP, U.S. Principal Investigator of REMAP and chair of Critical Care Medicine at UPMC and the University of Pittsburgh School of Medicine. “To have both of these results from REMAP-CAP published simultaneously is testament to the ability of this trial to efficiently evaluate multiple interventions. Through this horrific pandemic, we’ve pioneered a new way to rapidly address some of the biggest treatment questions, caring for patients today and preparing to respond more nimbly in the future. It has been personally rewarding to be a part of this process and see our aspirational goal become reality.”
REMAP-CAP is a global adaptive platform trial investigating multiple treatments for hospitalised patients with respiratory tract infection. The trial mobilised to evaluate specific treatments for COVID-19 patients in ICUs in early March 2020, and continues to evaluate multiple interventions for COVID-19, influenza, and other causes of severe respiratory infection.
The Global Coalition for Adaptive Research (GCAR) serves as U.S. Trial Sponsor of REMAP-COVID, a COVID-specific component of the REMAP-CAP adaptive platform trial with the University of Pittsburgh serving as the U.S. Regional Coordinating Center of REMAP-CAP.
A total of 290 U.S. patients participated in the vitamin C domain at UPMC, the Ohio State University Wexner Medical Center, and Oregon Health & Science University.
The REMAP-CAP Investigators. Simvastatin in Critically Ill Patients with COVID-19. NEJM. 2023; doi: 10.1056/NEJMoa2309995.
The LOVIT-COVID Investigators and the REMAP-CAP Investigators. Intravenous Vitamin C for Patients Hospitalized with COVID-19: Two Harmonized Randomized Clinical Trials. JAMA. 2023; doi: 10.1001/jama.2023.21407
REMAP-CAP is led by world experts in critical care, clinical trials, pandemic and infectious disease outbreaks, virology, immunology, emergency medicine, and Bayesian statistics. REMAP-CAP was developed to test treatments for severe pneumonia both in non-pandemic and pandemic settings. In February 2020, REMAP-CAP rapidly pivoted to its pandemic mode (the REMAP-COVID sub-study), as per its original intent, to incorporate additional potential treatment regimens specifically targeting COVID-19 and to expand enrollment to COVID-19 patients. This trial is a multicenter, randomized platform study, with treatments tested within groupings or “domains” based on pathway or mechanism of action. REMAP-CAP has enrolled over 12,000 patients at 365 sites across 28 countries. This vital research is supported by governments and non-profits worldwide. To learn more about REMAP-CAP and the REMAP-COVID sub-study, please visit www.remapcap.org and follow @remap_cap
About Global Coalition for Adaptive Research (GCAR)
The Global Coalition for Adaptive Research (GCAR) unites physicians, clinical researchers, advocacy and philanthropic organizations, biotech/pharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases. As Sponsor of innovative trials, including master protocols and adaptive platform trials, GCAR is dedicated to the advancement of science by modernizing clinical trials that support more efficient, less costly drug development. Adaptive platform trials can accelerate the time from discovery in the lab to implementation in the clinic resulting in better treatments and lives saved. To learn more about GCAR and its initiatives, visit gcaresearch.org.
UPMC is a world-renowned, nonprofit health care provider and insurer committed to delivering exceptional, people-centered care and community services. Headquartered in Pittsburgh and affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC is shaping the future of health through clinical and technological innovation, research, and education. Dedicated to advancing the well-being of our diverse communities, we provide more than $1 billion every year in community benefits, more than any other health system in Pennsylvania. Our 95,000 employees — including more than 5,000 physicians — care for patients across 40 hospitals and 800 doctors’ offices and outpatient sites in Pennsylvania, New York, and Maryland, as well as overseas. UPMC Insurance Services covers 4.5 million members with a focus on providing the highest-quality care at the most affordable price. To learn more, visit UPMC.com.
Global Coalition for Adaptive Research