Impact of self-administered pulse oximetry among non-hospitalized patients at risk of severe COVID-19 in Honduras: A pragmatic, block-randomized trial

The World Health Organization recommends remote monitoring and self-administered pulse oximetry to identify silent hypoxia and the need for medical intervention in non-hospitalized high-risk COVID-19 patients. These interventions have been evaluated previously, but evidence is needed to determine the impact on morbidity and mortality, particularly in lower- and middle-income countries. MethodsA prospective, pragmatic, open-label trial was conducted in Tegucigalpa and Comayaguela, Honduras to evaluate the impact of self-administered pulse oximetry to reduce morbidity and mortality among non-hospitalized patients at high risk of adverse COVID-19 outcomes enrolled in a remote monitoring program. Participants were block-randomized to remote monitoring plus self-administered pulse oximetry versus remote monitoring alone. Participants in the pulse oximetry arm received daily calls to assess for high-risk clinical features, including hypoxia (oxygen saturation: SpO2 [≤]94%) All participants reporting high risk symptoms were referred for in-person evaluation. The clinical trial is registered at https://clinicaltrials.gov/ct2/show/NCT04886414. FindingsBetween March 30, 2022 and January 24, 2023, 1,821 participants met the intention to treat analysis criteria, of whom 925 were randomized to remote monitoring and 897 to remote monitoring with pulse oximetry. Nearly ninety-nine percent of participants reported receiving one or more COVID-19 vaccine doses, and 90.2% three or more doses, with similar coverage across arms. Participants in the pulse oximetry arm were more likely to be referred for clinical evaluation (OR 1.60 [95% CI 1.09 - 2.46], p = 0.018), but not more likely to be hospitalized (OR 1.55 [95% CI 0.55 - 4.37, p = 0.401]. One participant died, two required intensive care, and none required mechanical ventilation; given limited data, these outcomes were not assessed. InterpretationFindings suggest that the use of self-administered pulse oximetry increased referral for additional care but did not result in different rates of hospitalization among a high-risk, but highly vaccinated, population with low rates of severe COVID-19. Given the infrequent progression to severe COVID-19, this trial did not assess whether self-administered pulse oximetry is related to mortality, need for mechanical ventilation, or admission to intensive care. FundingThe U.S. Centers for Disease Control and Prevention funded the trial and supported design, interpretation, and review. All decisions were taken by the primary investigator. Rapid antigen tests were donated by Roche Diagnostics, Ltd, which had no additional involvement.