COVID-19 Roundup: Breathalyzer Test, Updated WHO guidelines, and More

FDA Issues Emergency Use Authorization for InspectIR COVID-19 Breathalyzer¹

The US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for InspectIR COVID-19 Breathalyzer, the first diagnostic test that detects in breath samples volatile organic compounds associated with a SARS-CoV-2 infection. Trained operators supervised by a licensed or authorized provider can collect a breath sample and analyze it with the test in less than 3 minutes by using an instrument the size of a carry-on bag.

The approval was based on validation of the test in a study of 2409 participants that included individuals with and without symptoms. The study found that the test had 91.2% sensitivity and 99.3% specificity.

The FDA has recommended confirming positive results of the test with a molecular test and warned that negative results of the test do not rule out infection and should not be used as the sole basis for decision-making.

WHO Updates Recommended Drug Treatments²

The World Health Organization (WHO) issued the tenth version of its living guideline on the role of drug treatments for COVID-19 on April 21, 2022. This version includes new recommendations for patients with non-severe COVID-19.

For such patients at the highest risk of hospitalization, the Guideline Development Group strongly recommend nirmatrelvir/ritonavir treatment and conditionally recommend remdesivir treatment.

The group’s strong recommendation of nirmatrelvir/ritonavir is based on the combination’s relative ease of administration compared with intravenous agents such as remdesivir and monoclonal antibodies (mAbs). They added that mAbs provide less certain benefit for infection with omicron BA1-2 than for infection with other variants. The group also noted the greater safety of nirmatrelvir/ritonavir compared with molnupiravir.

In contrast, for patients with non-severe COVID-19 who have a low risk of hospitalization, the group conditionally recommends against nirmatrelvir/ritonavir treatment.

However, for patients with severe or critical illness, the group made no recommendation on nirmatrelvir/ritonavir treatment because of the paucity of available data from clinical trials.

Interaction Checkers Could Flag Drug-Drug Interactions in Those with COVID-19³

Using interaction checkers could have identified adverse reactions from drug-drug interactions (DDIs) in patients with COVID-19, according to the results of a systematic review.

They began their study by consulting online drug interaction checkers to analyze hypothetical adverse reactions from DDIs from March 2020 through February 2022. Then they searched medical literature databases for articles describing adverse events (AEs) resulting from DDIs and evaluated the ability of the checkers to identify such events.

This work identified 575 DDIs for 58 pairs of 46 different drugs and revealed that 305 of these pairs were associated with at least 1 adverse drug reaction, mainly from pairs including either lopinavir or ritonavir.

In the 20 studies (including nearly 1300 patients) that met inclusion criteria, 115 DDI-related AEs were reported; half could have been identified by at least one of the tools analyzed, 26% could have been identified by all of them, and 24% could not have been identified by any of them.

“Notwithstanding the emergency context of the COVID-19 pandemic, DDI-related adverse events should never be overlooked to customize the most effective and safest therapy,” researchers stressed.

Psychiatric Diagnoses Hiked Incidence of SARS-CoV-2 Breakthrough Infections⁴

Having received a diagnosis of a psychiatric disorder was associated with an increased incidence of SARS-Co-V-2 breakthrough infections, according to a retrospective cohort study of records data from more than a quarter-million vaccinated patients treated through the US Department of Veterans Affairs (VA) from February 20, 2020, to November 16, 2021.

More than half (51.4%) of these patients had at least 1 diagnosis of a psychiatric disorder, and 15% of them contracted a breakthrough infection. The relative risk such a diagnosis posed for breakthrough infection was 1.03 (95% CI, 1.01-1.05) after adjustment for comorbidities and smoking. In patients older than 65 years, this association was stronger and more robust to adjustment than in patients younger than 65 years old.

Diagnoses of adjustment disorder and substance use disorders posed the greatest risk of breakthrough infection.

“Individuals with psychiatric disorders may be at heightened risk for contracting COVID-19 even after vaccination, suggesting the need for targeted prevention efforts,” researchers concluded.

—Ellen Kurek

References:

1. U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first COVID-19 diagnostic test using breath samples: test provides results in less than three minutes. (press release) Published April 14, 2022. Accessed April 24, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples
2. Agarwal A, Rochwerg B, Lamontagne F, et al. A living WHO guideline on drugs for covid-19. BMJ. 2022;370:m3379. doi:10.1136/bmj.m3379
3. Conti V, Sellitto C, Torsiello M, et al. Identification of drug interaction adverse events in patients with COVID-19: a systematic review. JAMA Network Open. 2022:5(4):e227970. doi:10.1001/jamanetworkopen.2022.7970
4. Nishimi K, Neylan T, Bertenthal D, Seal KH, O’Donovan A. Association of psychiatric disorders with incidence of SARS-CoV-2 breakthrough infection among vaccinated adults. JAMA Network Open. 2022:5(4):e227287. doi:10.1001/jamanetworkopen.2022.7287