ECRMC to participate in drug trial
EL CENTRO – El Centro Regional Medical Center announced Thursday it is participating in a clinical trial to test the therapeutic value of an anti-inflammatory drug that has shown promise in the treatment of COVID-19 pneumonia.
This trial will study the drug tocilizumab, sold under the brand name Actemra, and evaluate its safety and efficacy in the treatment of patients with severe COVID-19 pneumonia. Tocilizumab is an approved treatment for rheumatoid arthritis and other inflammatory disorders.
It may also help treat patients who have developed or are at risk of developing serious lung damage from COVID-19 infections.
According to an April 29 release by UC San Diego Health, tocilizumab is a “monoclonal antibody-based therapy” that works by blocking cellular receptors for interleukin-6 (IL-6), a small protein or cytokine that plays an important role in triggering inflammation as an early immune response to disease. In some patients with COVID-19, however, the immune response runs amok, overexpressing IL-6 and generating a “cytokine storm,” which can lead to potentially life-threatening damage to lungs and other organs.
UCSD Health said previous research has suggested elevated levels of IL-6 are associated with higher mortality in people with community-acquired pneumonia. Chinese physicians reportedly used tocilizumab in the early days of the novel coronavirus outbreak last year to treat a small number of COVID-19 patients with serious lung damage, and shared promising results. The Chinese National Health commission now includes tocilizumab in its guidelines for treating COVID-19-related pneumonia and other lung issues.
“There are no specific therapies for COVID-19 at this time, but several are being investigated and are in clinical trials,” said Dr. Jorge F. Robles, principal investigator and chair of outpatient clinics at ECRMC. “Tocilizumab is one of the therapies bringing hope for treating this aggressive viral infection. We are very happy to participate in this trial and optimistic about its benefits to our patients at ECRMC.”
This Phase III clinical trial at ECRMC was approved by the U.S. Food and Drug Administration in early spring, the hospital said. While there are several independent clinical trials on the efficacy and safety of tocilizumab for COVID- 19 patients, this new trial will be a randomized, double- blind, placebo- controlled trial.
A double-blind and placebo- controlled clinical study is one in which neither the participant nor the researcher knows who is getting the drug treatment and who is getting the placebo in a controlled group.
Participants must be over 18 and hospitalized with a diagnoses of COVID-19 pneumonia and evidence of impaired gas exchange. Patients will receive one intravenous infusion of either tocilizumab or the placebo. A second infusion may be given if clinical symptoms worsen or improve.
Funding and resources for the trial are provided by the pharmaceutical company Genetech/Roche, which makes Actemra.
Patient participants will be followed for 60 days post-randomization and an interim analysis will be conducted for early evidence of efficacy.
Up to 60 ECRMC patients will participate in this study.
The hospital emphasized that these medical trials will be conducted by professionals in a controlled environment. The medications will be administered to participants by physicians who will monitor and evaluate the patients to ensure their safety.