OCD drugs look promising for COVID-19 outpatients

Eighty symptomatic COVID-19 patients who received the selective serotonin reuptake inhibitor (SSRI) fluvoxamine in a randomized trial showed clinical deterioration compared to 6 of 72 who received placebo. I couldn’t.

This translates into an absolute difference in risk of 8.7 percentage points (95% CI 1.8-16.4), reported by Dr. Eric Lenze of the University of Washington School of Medicine in St. Louis, Missouri.

More patients in the placebo group also experienced adverse events compared to the intervention group, the authors said. JAMA..

Ann Editor’s note Along JAMA Deputy Editor-in-Chief of the University of Pittsburgh, Ph.D. JAMA Editor Howard Boschner, MD, characterized this as a “pilot study” representing preliminary evidence and warned readers that the findings should be interpreted as “hypothesis generation.”

However, most of the more than 10,000 COVID-19 submissions received since February 2020 were rejected. They announced this because they were “double-blind, placebo-controlled, randomized clinical trials, generally considered to be designed to minimize bias and support causal reasoning.” Said. Needed from large-scale testing.

They also noted the unique design of the study: “no direct contact with self-quarantined participants”, “remote” trials, and data collected through patient self-reports and telephone interviews.

“These individual components are part of other trials, but the current trials are combined with a contactless design to protect both participants and researchers during a pandemic,” the editor said. writing.

Lenze et al. State that COVID-19 lung damage is due to an excessive inflammatory response, and that a potential mechanism of immunomodulation is sigma 1 receptor (S1R) agonism. They found that fluvoxamine, an SSRI and S1R agonist used to treat some forms of obsessive-compulsive disorder and social anxiety disorder in previous studies, was a detrimental aspect of the inflammatory response during sepsis in preclinical models. He said he found it useful in alleviating.

The survey was conducted in the St. Louis metropolitan area from April 10th to August 5th. Each participant was “non-contact” as they received their assigned medications, oxygen saturation and blood pressure monitors, and thermometers in packets at the door. The patient took his vital sign and the staff called them to let them know when to take the study drug. Data collection was performed by email survey twice daily, using the telephone as a backup, and patients reported oxygen saturation, vital signs, medication compliance, and COVID-19 symptoms.

Participants were unhospitalized adults with SARS-CoV-2 infection confirmed by PCR assay, symptomatic within the first 7 days of initial administration of the study drug, and oxygen saturation of 92% or higher. In some cases it was eligible.

Fluvoxamine was administered at 50 mg on the first day, then within the acceptable range of 100 mg twice daily for 2 days, and up to the 15th day within the acceptable range of 100 mg 3 times daily. The primary endpoint was clinical deterioration within 15 days. This result is defined as the presence of dyspnea or hospitalization due to shortness of breath or pneumonia, the oxygen saturation of the room air dropping to less than 92%, or the oxygen supplement required to maintain oxygen saturation above 92%. I did.

Of the six exacerbated placebo patients, four were hospitalized, stayed for 4-21 days, and one patient required mechanical ventilation for 10 days. No patient died.

However, 18 participants in the fluvoxamine group, like 19 patients in the placebo group, stopped responding to the study before day 15.

One serious adverse event was reported in the intervention group, and 6 serious adverse events and 12 other adverse events were reported in the placebo group. Pneumonia and gastrointestinal symptoms occurred more frequently in the placebo group.

Lenze et al. Stated that the underlying mechanism behind the effectiveness of fluvoxamine needed “further elucidation,” but it was widely available, low cost, orally available to outpatients, and prolonged QT. He said he would not promote it. However, they added that it has adverse events and can cause drug-drug interactions.

The limitations of this study are the small sample size and geographic area, the small number of endpoint events, and the difference in clinical exacerbations due to “comparison of baseline distributions of oxygen saturation, not therapeutic effects.” It may be a thing.