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

The ORCHID Study is a blinded, placebo-controlled randomized clinical trial of oral doses of hydroxychloroquine as compared to a matching placebo to treat patients hospitalized with COVID-19 illness. The multi-center study aims to determine if among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at day 15. The study is being conducted by the PETAL network, which studies acute lung injury, of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
Learn more about this clinical trial.

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.

The randomized, double-blind, placebo controlled, multi-center study evaluates tocilizumab in hospitalized patients with severe COVID-19 pneumonia. This study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of tocilizumab compared with a matching placebo in combination with standard of care in hospitalized patients with severe COVID-19 pneumonia.
Learn more about this clinical trial.

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.

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.

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.