Leading the Way in Innovative Research for COVID-19 Patients

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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:

Therapeutic Studies

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.

Canakinumab
The prospective, Phase 2, single center, blinded randomized-controlled study is designed as a proof of concept to demonstrate that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID 19 infection, myocardial injury and hyperinflammation. These results will lead to a Phase III randomized placebo-controlled trial.
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.

Mavrilimumab
This prospective, Phase 2, multicenter, blinded, randomized placebo-controlled trial will study early treatment with mavrilimumab, a monoclonal antibody that targets inflammation, to determine if it can prevent progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation. Multiple centers will be involved in this trial, with Cleveland Clinic C5 research performing data collection, data analysis, and randomization scheme.
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.  

Other research

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.

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.