September 23, 2021 by John Fernandez and Bethany Rundell
In COVID-19 Clinical Trials, Experts from Baptist Health’s Cancer Institutes Treat Patients With Mild or Severe Symptoms
Offering more hope to patients with COVID-19, cancer experts throughout Baptist Health South Florida are launching new clinical trials. The trials, developed as a result of promising initial emergency and experimental COVID-19 therapies at Miami Cancer Institute on the Baptist Hospital campus in Miami and at the Eugene M. & Christine E. Lynn Cancer Institute at Boca Raton Regional Hospital, span the range of care from the most critically ill to those with mild symptoms.
“It’s exciting to lead these next-generation clinical trials,” said Guenther Koehne, M.D., Ph.D., principal investigator of two of the studies, and director and chief of Stem Cell Transplantation, Hematologic Oncology and Benign Hematology at Miami Cancer Institute. “We have learned much about COVID-19 since the pandemic began last winter and our hope is that these trials will lead to tremendous treatment options for patients.”
Specialists at both centers are accomplished in many of the techniques and technologies that are doing double-duty as oncology and COVID-19 treatments and pivoted at the start of the pandemic to lead numerous COVID-19 clinical trials.
Trial to Save the Most Critical Patients
Miami Cancer Institute is leading a phase I/IIa clinical trial using mesenchymal stem cells for critically ill patients with COVID-19 induced respiratory failure. Mesenchymal stem cells are derived from umbilical cord lining tissue and aid in healing by regenerating damaged lung tissue. The trial is for hospitalized patients who are receiving oxygen therapy or who are on ventilation support and are not showing improvement.
Early in the pandemic, Miami Cancer Institute treated several patients with mesenchymal stem cells through single-use emergency approval from the U.S. Food and Drug Administration (FDA). The patients, who were among the most ill COVID-19 patients, recovered.
“In our early experience with these umbilical cord lining stem cells, we had very promising results,” Dr. Koehne said. “We are very hopeful that the clinical trial will give us evidence that this treatment can save the lives of those who experience respiratory failure due to COVID-19.”
Low-dose Radiation may Reverse Pneumonia
Both Lynn Cancer Institute and Miami Cancer Institute are participating in the PREVENT trial, Low-Dose Radiotherapy for Patients with SARS-COV2 (COVID-19) Pneumonia. With a single, low-dose of thoracic radiation, researchers hope that inflammation in the lungs is reduced and that patients with pneumonia associated with COVID-19 may not need to be placed on a ventilator.
“We have seen this treatment option benefit many cancer patients, and the hope is that it also helps those affected by the virus,” said Minesh Mehta, M.D., co-principal investigator, deputy director and chief of Radiation Oncology at Miami Cancer Institute.
Patients eligible for the study include hospitalized men and women ages 50 and up who are diagnosed with COVID-19 and pulmonary pneumonia but who are not on ventilators.
“This trial gives us the opportunity to administer potentially effective treatment before the need for ICU placement or mechanical ventilation,” said Michael Kasper, M.D., co-principal investigator and director of Radiation Oncology at Lynn Cancer Institute.
Radiation therapy has shown a reduction in inflammation in a number of conditions, including viral pneumonia, autoimmune disorders and degenerative joint disorders. At much higher doses, it is also used to treat cancer.
Trial to Shorten Recovery and Reduce Symptoms For Those With Mild Disease
Miami Cancer Institute is also enrolling patients in a phase 2 clinical trial known as BLAZE-4, which continues previous work using a monoclonal antibody, bamlanivimab, to treat patients with milder cases of COVID-19. The Institute participated in the phase 1 study, BLAZE-1, which resulted in Emergency Use Authorization (EUA) status by the FDA.
Bamlanivimab is for patients who are COVID-19 positive but are not hospitalized and have mild symptoms. It must be administered within 72 hours of a positive test result.
The BLAZE-1 study showed a lower subsequent hospitalization rate among those who received the drug versus those who received a placebo, and may reduce the viral load, leading to better outcomes. The BLAZE-4 trial will evaluate the efficacy and safety of bamlanivimab both on its own and in combination with another monoclonal antibody. The drugs work by prohibiting the spread of the virus to additional cells in the body.
“We have reached a new level of sophistication ―trying to treat the virus before it makes you really sick,” Dr. Koehne said. “Despite the prospect of having COVID-19 vaccines, which are intended to prevent us from getting sick, we need to stay focused on the treatment of those individuals who are symptomatic from the virus.”