Upon the advent of the COVID-19 pandemic and all that has come along with this unprecedented event, Temple University Hospital has significantly responded with a diversified clinical research program—including participation in a variety of clinical trials that are testing investigational treatment options for patients diagnosed with SARS-CoV-2: the virus behind the COVID-19 pandemic. It has had to. Based on its location, it has been on the front lines in the war against COVID-19.
COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While many COVID-19 patients will experience mild to moderate respiratory illness and recover, others will face lung injury, acute respiratory distress syndrome (ARDS), and even death. That death toll is not proportionate from a demographic standpoint.
‘Philadelphia’s COVID-19 Hospital’
Temple University Hospital is set in a dynamic, concentrated and historic part of Philadelphia. COVID-19 has been especially hard on inner-city eastern cities such as Philadelphia—New York, of course, is the epicenter. In Philadelphia County, as of this writing 11,885 reported COVID-19 cases is more than 33 other states and the District of Columbia—the current death toll of 424 exceeds 34 states. Located in an area with large concentrations of African American populations, as of April 8 Black Philadelphians were dying at the highest rate. Philadelphia city has a large Black population of about 42%. Hence Temple University Hospital truly can be considered on the front lines of this battle. In fact the Philadelphia Inquirer labeled the hospital “Philadelphia’s busiest COVID-19 hospital.” TrialSite News has bought to the TrialSite Network’s attention that Black’s were dying at far higher rates.
Clinical Research as a Care Option
For too long clinical trials have been disconnected from the care offered by providers which in many cases treat them as a separate industry. At Temple University Hospital, operating in a dynamic and at times challenging North Philadelphia district—and based on the elements discussed earlier—understands that connecting clinical trials as part of a healthcare continuum to a patient’s specific needs represents a commitment to not only delivering the standard of care but an imperative for the patient. As Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, noted, “At the Temple Lung Center, we have always been committed to research and to providing our patients with access to the latest treatment options that are available for their particular condition.” He continued, “That remains true for those diagnosed with COVID-19, a devasting virus that we continue to learn more about with each passing day.”
The COVID-19 clinical trials and investigational treatments currently offered at Temple University Hospital include:
Convalescent plasma: This Phase 2 randomized study will utilize plasma from patients who have recovered from a SARS-CoV-2 infection. The study will evaluate the safety and efficacy of treatment with SARS-CoV-2 immune plasma relative to a control arm of SARS-CoV-2 non-immune plasma in patients exposed to COVID-19. This multi-site, interventional clinical trial will enroll up to 150 patients. >Mohamed S. Alsammak, MD, Assistant Professor of Clinical Pathology and Laboratory Medicine at LKSOM and Director of the Blood Bank/Transfusion Medicine at Temple University Hospital, is the principal investigator at TUH.
Gimsilumab: The BREATHE clinical trial is a Phase 2 randomized study that will evaluate the safety and efficacy of gimsilumab in patients with COVID-19 and ARDS. The trial, for which Temple University Hospital treated the first patient in the United States, will evaluate the impact of gimsilumab on mortality in these patients. Gimsilumab is a fully human monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF), which is believed to be a key driver of lung hyper-inflammation. The primary endpoint is mortality by Day 43. Key secondary endpoints include the incidence and duration of mechanical ventilation use during the study, number of days in the intensive care unit, and number of days of inpatient hospitalization. This multi-site, interventional clinical trial will enroll up to 270 patients. Dr. Criner is the principal investigator at TUH.
Hydroxychloroquine: The HERO-HCQ clinical trial is a Phase 3 randomized study that will evaluate whether hydroxychloroquine is better than placebo in preventing COVID-19 infection in health care workers. Hydroxychloroquine is a U.S. Food and Drug Administration (FDA)-approved medication for malaria, lupus, and rheumatoid arthritis. This multi-site, interventional clinical trial will enroll up to 15,000 health care workers at risk of being exposed to SARS-CoV-2. The principal investigators at Temple University Hospital are Anuradha Paranjape, MD, MPH, FACP, Professor of Medicine, Professor of Clinical Sciences, and Vice Chair of Clinical Affairs in the Department of Medicine at LKSOM; Nina Gentile, MD, Professor of Emergency Medicine at LKSOM; and Gustavo Adolfo Fernandez Romero, MD, Assistant Professor of Clinical Thoracic Medicine and Surgery at LKSOM.
Hydroxychloroquine: The ORCHID clinical trial is a Phase 3 randomized study to evaluate whether hydroxychloroquine is better than placebo in the treatment of adults hospitalized with COVID-19. Clinical outcomes will be evaluated on a seven-point scale on Day 15. This multi-site, interventional clinical trial will enroll up to 510 patients. Dr. Gentile is the principal investigator at TUH.
Remdesivir: This Phase 3 randomized study will evaluate the safety and efficacy of two remdesivir regimens with respect to clinical status of patients with severe COVID-19 on a seven-point scale on Day 14. Remdesivir is an antiviral medication. This multi-site, interventional clinical trial will enroll up to 6,000 patients. Dr. Criner is the principal investigator at TUH.
Remdesivir: This Phase 3 randomized study will evaluate the safety and efficacy of two remdesivir regimens compared to standard of care with respect to clinical status of patients with moderate COVID-19 on a seven-point scale on Day 11. This multi-site, interventional clinical trial will enroll up to 1,600 patients. Dr. Criner is the principal investigator at TUH.
Sarilumab: This is an adaptive Phase 2/Phase 3 randomized study to evaluate the safety and efficacy of sarilumab. Sarilumab is an FDA-approved medication for adults with moderate to severe rheumatoid arthritis. It is a monoclonal antibody that binds to the interleukin-6 receptor, a cytokine associated with inflammation, and is being investigated for its ability to reduce the overactive inflammatory immune response associated with COVID-19. The preliminary Phase 2 results show great outcomes for patients who received a higher dose (400 milligrams) and fall within the “critical” respiratory illness category, which, for this trial, means they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit. While the results were not matched with a lower dosage (200 milligrams) or for patients categorized as “severe” or those with multi-system organ dysfunction, the Phase 3 trial will continue in the more advanced “critical” group with the higher dose (400 mg) compared to placebo. Temple has enrolled more than 150 patients in this multi-site, interventional clinical trial. Dr. Criner is the principal investigator at TUH.
Inhaled nitric oxide: Temple University Hospital is utilizing the INOpulse system to provide precise, constant dosing of inhaled nitric oxide to patients who are highly suspected or confirmed to have COVID-19 and require supplemental oxygen. Patients will be evaluated on an eight-point scale on Day 15. This is an investigational product that is available via the FDA’s emergency expanded access program. Nitric oxide is a vasodilator, which means it opens up blood vessels, thereby lowering blood pressure and increasing blood flow. Jeffrey I. Stewart, MD, Associate Professor of Clinical Thoracic Medicine and Surgery at LKSOM, is the principal investigator at TUH.
About Temple University Health
Temple University Health System (TUHS) is a $2.2 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH); TUH-Episcopal Campus; TUH-Jeanes Campus; TUH-Northeastern Campus; The Hospital of Fox Chase Cancer Center and Affiliates, an NCI-designated comprehensive cancer center; Temple Transport Team, a ground and air-ambulance company; Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices; and Temple Faculty Practice Plan, Inc., TUHS’s physician practice plan comprised of more than 500 full-time and part-time academic physicians in 20 clinical departments. TUHS is affiliated with the Lewis Katz School of Medicine at Temple University.