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As the COVID-19 pandemic continues, there is great interest in studying treatment and prevention approaches for the disease. Cleveland Clinic is participating in a number of research projects related to COVID-19. As an international leader in biomedical research, Cleveland Clinic has formed a multidisciplinary clinical trials committee to evaluate therapies for mild to severe disease, with the goal of supporting trials that are scientifically sound and prioritizing those with the potential for significant impact on clinical care.
Among others, some of the clinical trials conducted at Cleveland Clinic include:
COVIDAtoZ
This investigator-initiated trial looks at the effect of high dose vitamin C and zinc in outpatient COVID-19 patients on symptom severity and duration and hospitalization. This is a single-center, prospective, randomized study. Some patients will receive high dose vitamin C, some high dose zinc, some both, and some will receive neither.
Learn more about this clinical trial.
Mesenchymal Stromal Cells in COVID-19 ARDS (Acute Respiratory Distress Syndrome)
The mortality rate in COVID-19 related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung counteract the inflammatory process by reducing the production pro-inflammatory cytokines (small proteins), increasing the production of anti-inflammatory cytokines enabling recruitment of naturally occurring anti-inflammatory cells to involved tissue. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS.
The primary objective of this multi-center, phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers. The study is through the Cardiothoracic Surgical Trials Network and sponsored through the NHLBI.
Learn more about this clinical trial.
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection (ALI)
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous dose of VIB7734 in hospitalized patients with documented COVID-19 infection with pulmonary involvement. Participants will be followed for 30 days to assess the effectiveness of the treatment and monitored for 10 weeks for safety. The aim of the drug is to regulate the immune response associated with COVID-19 infection as it is a monoclonal antibody that depletes peripheral dendritic cells, which are involved in inflammation.
Learn more about this clinical trial.
ILIAD-7:Interleukin 7 to Improve Outcomes in Lymphopenic Patients w/ COVID-19
This study is designed to evaluate the potential ability of IL-7 (CYT107) to decrease Intensive Care Unit (ICU) treatment requirements and reduce mortality by reversing lymphopenia (a lower-than-normal number of lymphocytes (a type of white blood cell) in the blood). and T cell exhaustion in COVID-19 patients, or accelerating such reversal, and avoiding, reducing or resolving secondary infections. Although multiple studies are aimed at treatments for the inflammatory characteristics of COVID-19 infection, lymphopenia and T-cell exhaustion have been largely overlooked as a focus for treatment intervention and to date, are major factors in COVID-19 mortality.
Learn more about this clinical trial.
COVID-19 Research Registry
A research registry of nearly 23, 000 patients is collecting data from patients tested for COVID-19 at Cleveland Clinic. This research registry, which includes patients with positive and negative results, will be able inform other studies, such as the development of tools to predict risk and outcomes in patients. Researchers from across the Cleveland Clinic enterprise are using the dynamic registry data in more than 140 COVID-19 related research projects in areas such as cancer, pediatrics, intensive care.
Convalescent Plasma
Cleveland Clinic and Cleveland Clinic Florida has an expanded access protocol for the use of convalescent plasma therapy for patients admitted with moderate to severe COVID-19. Convalescent plasma therapy, which collects antibody rich plasma from donors who have recovered from COVID-19, is used for patients currently struggling with the virus. In Florida, the convalescent plasma collection will be collected by OneBlood, an independent not-for-profit blood bank serving Florida. In Ohio, the American Red Cross and other blood centers are collecting and distributing convalescent plasma and are seeking potential donors.
AI Drug Repurposing for COVID-19
Cleveland Clinic researchers published findings last month on a network-based prediction model using artificial intelligence to identify targets for drug repurposing in coronavirus and COVID-19. Their approach targets the interaction between human and virus proteins rather than the virus protein itself. Based on their findings, they prioritized 16 drugs and three drug combinations as potential treatments.
American Heart Association COVID-19 Heart and Brain Research Initiative
The American Heart Association has awarded $1.2 million in grants to teams at 12 institutions across the U.S. to begin fast-tracked studies of the effects of COVID-19 on the body’s cardiovascular and cerebrovascular systems. Cleveland Clinic will serve as the initiative’s COVID-19 Coordinating Center and will collect results from the research projects and coordinate the dissemination of all study findings.
Learn more about this initiative.
Tracking COVID-19 Transmission Patterns
A team of Cleveland Clinic and Case Western Reserve University researchers is analyzing COVID-19 patient data to better understand how the virus spreads and where various strains originate. Supported by a special COVID-19 fund from the National Science Foundation (NSF),the team is conducting an epidemiologic analysis using data from patient samples collected at Cleveland Clinic. They will sequence the genome from about 400 of the 2,000 samples to study mutations and use computational algorithms to mine patterns from the genetic sequences. Coupled with epidemiologic data from each affected individual, such as demographic information and diagnosis date, the information will provide new insights into transmission patterns of the novel coronavirus, SARS-CoV-2.
Identifying Ways to Improve Experience and Quality of Care among Patients with COVID-19 Managed at Home
In this study, researchers will use a mixed methods approach to assess the experience and quality of care of Cleveland Clinic patients with COVID-19 being managed at home. Many Cleveland Clinic patients with COVID-19 are being managed at home using the MyChart Care Companion tool, which provides virtual check-ins and digital care management to facilitate cross-continuum engagement, remote monitoring and patient reported outcomes (PROMs) data collection. All Cleveland Clinic patients with COVID-19 are eligible for the study, regardless of whether or not they enroll in Care Companion. The study will assess whether or not Care Companion is associated with improved patient experience, reduced anxiety at home, improved self-care management, higher knowledge of COVID-19, improved outcomes and higher quality care.
National Cancer Institute’s Serological Sciences Network for COVID-19
A collaboration between Cleveland Clinic and Case Western Reserve University is part of the National Cancer Institute’s Serological Sciences Network for COVID-19 (SeroNet). A newly launched initiative, SeroNet comprises some of the nation’s top biomedical research centers, bringing immunology experts together to better understand the immune system’s response to COVID-19. The network aims to combat the pandemic by improving the ability to test for infection and speed the development of treatments and vaccines.
BEAT COVID
This study will evaluate the sleep habits and wellbeing of Cleveland Clinic caregivers who provide direct patient care. The six-month study will explore how physiology interacts with sleep and stress in frontline caregivers during the pandemic. Participants will wear a WHOOP strap, an arm or wrist band heart rate monitor which measures heart rate (HR), heart rate variability (HRV), respiratory rate (RR) and sleep duration and quality. They will complete a brief daily questionnaire that focuses on daily sleep patterns, timing of work shifts and direct patient care responsibilities. All data will be tracked in an app that is connected to the WHOOP monitor, which participants will be able to access via their mobile device. The data will also be evaluated as early indications of COVID-19 infections in asymptomatic individuals.
Please note: Investigators on one or more of these studies may have financial interests related to the research sponsor or products under evaluation. These conflicts of interest have been reviewed by Cleveland Clinic’s Innovation Management and Conflict of Interest Program.
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. Cleveland Clinic is consistently recognized in the U.S. and throughout the world for its expertise and care. Among Cleveland Clinic’s 81,000 employees worldwide are more than 5,743 salaried physicians and researchers, and 20,160 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,690-bed health system that includes a 173-acre main campus near downtown Cleveland, 23 hospitals, 276 outpatient facilities, including locations in northeast Ohio; Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2023, there were 13.7 million outpatient encounters, 323,000 hospital admissions and observations, and 301,000 surgeries and procedures throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 132 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/CleClinicNews. News and resources available at newsroom.clevelandclinic.org.
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