The FDA issued an emergency use authorization (EUA) on Nov. 9 for bamlanivimab, an investigational monoclonal antibody therapy, to treat mild to moderate COVID-19 in adult and some pediatric patients. The drug is not authorized for hospitalized patients, an agency press release noted. The EUA is based on an unpublished interim analysis of a phase 2 trial of 465 patients that found a difference on a predefined secondary endpoint of hospitalization or ED visit related to COVID-19 within 28 days of treatment (3% on the drug vs. 10% on placebo).
A Viewpoint published by JAMA on Nov. 11 expressed concerns about potential EUAs for monoclonal antibody treatments, noting the issues of limited availability, complicated administration (one-hour IV infusion), and potentially high costs for these outpatient medications. “Failure to address these issues will intensify the numerous challenges that the health care system has faced throughout this pandemic, will result in a repeat of shortcomings and failures with achieving an effective and equitable therapeutic response, and importantly, will only exacerbate the disparities in care and outcomes related to this disease,” the authors wrote.
Another Viewpoint by Anthony S. Fauci, MD, MACP, and others reviewed the status of potential outpatient therapies for COVID-19 and identified similar concerns but came to a more hopeful conclusion. “It is encouraging that effective outpatient treatments for early COVID-19 are on the horizon; these efforts deserve the full support of the medical community and the public.”
In other experimental treatment news, fluvoxamine, a selective serotonin reuptake inhibitor and σ-1 receptor agonist, showed benefit in a small trial of nonhospitalized patients with COVID-19. The results were published as a preliminary communication by JAMA on Nov. 12. Of the 80 patients randomized to 100 mg of fluvoxamine, none met the primary outcome of requiring hospitalization or having oxygen saturation less than 92%, while six of the 72 patients on placebo did (P=0.009). The findings should be considered preliminary, and larger randomized trials with more definitive outcomes are needed, the authors said.
Psychiatric problems after infection were found in a study of more than 60,000 COVID-19 patients published by The Lancet Psychiatry on Nov. 9. A diagnosis of COVID-19 was associated with significantly increased incidence of a first psychiatric diagnosis in the following 14 to 90 days compared with other health events (such as influenza or fracture of a large bone), with the greatest increases seen in anxiety, insomnia, and dementia. In total, 18.1% of the COVID-19 patients received a psychiatric diagnosis. The association was bidirectional; patients with a psychiatric diagnosis in the previous year were more likely to be diagnosed with COVID-19. The authors noted that the study was limited by the possibility of residual confounding and the results need to be confirmed but “provide minimum estimates of the excess in psychiatric morbidity to be anticipated in survivors of COVID-19 and for which services need to plan.”
Finally, an analysis of 1,648 patients hospitalized with COVID-19 in Michigan in March through June, published as a letter in Annals of Internal Medicine on Nov. 11, looked at outcomes at 60 days after discharge. It found that 75.8% survived to discharge, but by 60 days, an additional 84 patients had died, bringing the overall mortality rate to 29.2% (63.5% in the 405 ICU patients). The 60-day readmission rate was 15.1%. Of 488 patients surveyed at 60 days, 265 had seen a primary care physician within two weeks of discharge. They reported a variety of ongoing issues including cardiopulmonary symptoms, psychological problems, and financial impacts. “These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” the study authors said. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary.”