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ORAL GARGLE OF ETHANOL-BASED MOUTHWASH SOLUTION AND ITS EFFECTS ON ADULT PATIENTS WITH MILD COVID-19 INFECTION: AN OPEN LABEL-RANDOMIZED CONTROLLED TRIAL

      TOPIC: Chest Infections
      TYPE: Late Breaking
      PURPOSE: COVID-19 is a contagious and rapidly evolving disease, that has a great potential to overwhelm our health system. Oral antisepsis could lower the number of infectious aerosolized virus particles. Hypothetically decreasing the risk of transmission, infection, disease severity, and bad outcomes. Among all the potential benefits of oral antisepsis, this study focuses on its effect on outcomes of the disease. The reduction in the viral load through surface debridement could aid in improving the overall symptoms of the patients and reduce disease severity and progression. It can also prevent secondary bacterial infection should the disease progress. The Philippines is a resource restrained country, simple intervention against the current crisis is needed.
      METHODS: The study is an Open-Labelled Randomized Controlled Trial. The study’s sample size was 60 participants. The sample size was computed accepting a power of 90% (CI 95%). The study participants were randomly assigned into two study groups. The treatment arm was given with ethanol-based oral anti-septic solution to be taken as oral gargle of 20 ml for 30 seconds three times a day, aside from standard of care. While the control received standard of care for mild disease. The WHO progression score, was used in the study as a means to monitor status daily and to assess progression. Participants were asked if they experienced any adverse events with the use of the oral solution. The difference between the groups will be considered statistically significant at a two-sided P value of <.05.
      RESULTS: The two groups were comparable using the Levene's test for homeogeneity, except for age. It was noted that the mean age for the control group was younger (Mean 35) as compared with the OGE group (Mean 43). In terms of disease progression, there is noted no significant difference between the control group and the test group (p=0.74; 95%). We then analyzed the severity of progression between the two groups, we found no significant difference between the two groups (p=0.49; 95%). However, we found out that those who progressed and those who did not progressed on the test group, have different time interval when they started taking the ethanol based oral solution. The mean time interval of 6.8 days and 3.4 days on those who progressed and those who did not progressed on the test group and was found to be statistically significant (p=<.001; 95%). Sub group analysis was done and we found out that the delay on the release of result of rtPCR and delay on patient consult were the factors. There are no significant adverse events reported aside from temporary discoloration of the teeth and the stinging sensation upon use.
      CONCLUSIONS: The use of an ethanol based oral gargle solution has no significant effect comparing to standard of care in terms of disease progression among adult patients with mild COVID-19. With the limitation of the study, further research to validate the result of this randomized controlled trial is warranted. To determine if there will be favorable effect in terms of disease progression when used early, the reasearchers recommend to enroll the participants less than 5 days from day 1 of illness.
      CLINICAL IMPLICATIONS: We do not recommend the use of ethanol based oral antiseptic solution in decreasing the incidence of progression of mild COVID-19 among adult population. Further study should be done in order to determine if there will be favorable outcome when given less than 5 days from symptom onset.
      DISCLOSURES: No relevant relationships by MA TERESA TRICIA BAUTISTA, source=Web Response
      No relevant relationships by Ma. Angelica Exconde, source=Web Response
      No relevant relationships by Joel Santiaguel, source=Web Response
      No relevant relationships by Lawrence Cyril Vitug, source=Web Response