Clinical trial finds inhaled immune response protein increases odds of recovery for hospitalised COVID-19 patients

 

by Lancet

via MedicalXpress - November 13, 2020

 

Hospitalised COVID-19 patients in the UK who received an inhaled form of interferon beta-1a (SNG001) were more likely to recover and less likely to develop severe symptoms than patients who received a placebo, according to a new clinical trial published in The Lancet Respiratory Medicine journal. This is the first evidence published in a peer-reviewed medical journal that inhaled interferon beta-1a could lessen the clinical consequences of COVID-19 and serves as proof-of-concept that this treatment could help hospitalised patients recover, but further research is required.

 

As the number of COVID-19 infections continues to rise around the world, there is a pressing need to develop new treatments for the more severe and life-threatening symptoms such as pneumonia and respiratory failure.

 

Interferon beta is a naturally occurring protein that coordinates the body's immune response to viral infections. Laboratory studies have found that the SARS CoV-2 virus directly suppresses the release of interferon beta, while clinical trials demonstrate decreased activity of this important protein in COVID-19 patients. The formulation of interferon beta used in this new study—SNG001—is directly delivered to the lungs via inhalation and has been trialled in the treatment of asthma and chronic obstructive pulmonary disease (COPD). This study aimed to evaluate the safety and efficacy of SNG001 to treat hospitalised COVID-19 patients.

 

The trial was conducted at nine UK hospitals with patients who had a confirmed SARS-CoV-2 infection. It compared the effects of SNG001 and placebo given to patients once daily for up to 14 days, and followed up patients for a maximum of 28 days after starting the treatment. Patients were recruited from March 30 to May 30, 2020, and were randomly assigned to receive the treatment or a placebo. All members of the research team were blinded to which group the patients were allocated. During the study, changes in the clinical condition of patients were monitored.

 

Of the 101 patients enrolled in the study, 98 patients were given the treatment in the trial (three patients withdrew from the trial) - 48 received SNG001 and 50 received a placebo. At the outset of the trial 66 (67%) patients required oxygen supplementation at baseline (29 people in the placebo group and 37 in the SNG001 group). Patients who received SNG001 were twice as likely to show an improvement in their clinical condition at day 15 or 16, compared with the placebo group.

 

In the placebo group, 11 (22%) of 50 patients developed severe disease (defined in this study as requiring mechanical ventilation) or died between the first dose and day 15 or 16, compared with six (13%) of 48 patients who received SNG001 (this includes three deaths in the placebo groups and none in the treatment group).

 

Over the 14-day treatment period, patients who received SNG001 were more than twice as likely to recover, compared to those in the placebo group—with 21 (44%) patients in the SNG001 group recovering compared with 11 (22%) patients in the placebo group (patients were deemed to have recovered when they were no longer limited in their activity). In a secondary analysis, the authors found that at 28 days, SNG001 patients were over three times more likely to recover than patients receiving placebo.

 

Lead author, Professor Tom Wilkinson from the University of Southampton, UK, says:

 

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