Temple University Hospital is now participating in a variety of clinical trials that are testing investigational treatment options for patients diagnosed with the novel coronavirus, or 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.
“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,” said 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. “That remains true for those diagnosed with COVID-19, a devastating 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.
CPI-006: Temple University Hospital treated the first 5 patients in the United States as part of this phase 1 clinical trial investigating a novel immunotherapy approach for patients with COVID-19. CPI-006 is an agonistic, or immunostimulatory, humanized, monoclonal antibody. The open-label, Phase 1 study is expected to enroll up to 30 COVID-19 patients with mild to moderate symptoms at several sites in the U.S. The objective of the study is to show that CPI-006 has the potential to induce the patient to produce an enhanced antibody response to SARS-CoV-2, the virus that causes COVID-19. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study also will examine safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization. Dr. Criner 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.
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.
This release was updated on July 7, 2020, to include a new Phase 1 study called CPI-006.