Phase 3 Study Evaluating CRS in Covid-19 Patients with Pneumonia

Researchers at The University of Texas Health Science Center at Houston (UTHealth) in the US are studying the effectiveness of an arthritis drug in treating a type of severe immune overreaction seen in patients with Covid-19 induced pneumonia in a Phase 3 clinical trial.

The clinical trial is enrolling patients at the Harris Health System's Lyndon B. Johnson Hospital in Houston, Texas.

The Phase 3 study is evaluating the effectiveness of the drug canakinumab, an interleukin-1 (IL-1) blocker approved for the treatment of juvenile rheumatoid arthritis, for preventing cytokine release syndrome (CRS) in Covid-19 patients with pneumonia.

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Often referred to as a cytokine storm, CRS is a life-threatening immune reaction caused by the body releasing too many cytokines into the blood at once.

Cytokines include a broad category of proteins secreted by the body.

Interleukin-1 serves as the first-line defence for the immune system, alerting other proteins to respond if a virus or bacteria are present.

Canakinumab blocks the production of IL-1 protein, which could prevent a possible deadly overreaction of the immune system in Covid-19 patients.

Research has linked a number of Covid-19 deaths to CRS due to damage caused to several major organs.

Roberto C. Arduino, MD, the study's lead investigator and professor of infectious disease at the McGovern Medical School in UTHealth, said this is a time for the HIV research community to utilise the members' expertise in the search for a treatment for coronavirus.

Arduino's research background includes the study of new antiretroviral drugs, treatment strategies, immune activation, and inflammation in the search of an HIV cure.

"The research community truly feels compelled to do something in the search for a viable treatment for Covid-19, and I feel I owe it to my community to offer my expertise," said Arduino, who has led HIV clinical research for 22 years.

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Researchers are investigating if canakinumab combined with standard-of-care treatment can increase the chances of survival without ever requiring invasive mechanical ventilation in patients with Covid-19-induced pneumonia.

Over a two-hour period, patients who are enrolled will receive either a 450 mg, 600 mg, or a 750 mg IV dose of canakinumab based on their body weight, UTHealth said in a statement on Monday. Arduino is the study's lead investigator.

All participants will be monitored for up to 29 days, or until they are discharged from the hospital. A follow-up will occur at 127 days. (IANS)