Abstract
Background
Medications studied for therapeutic benefits in coronavirus disease 2019 (COVID-19) have produced inconclusive efficacy results except for steroids.
Objective
A prospective randomized open-label, parallel-arm Phase I/II clinical trial was planned to compare essential oil (EO) blend versus placebo nebulization in mild COVID-19.
Methods
A Phase I safety evaluation was carried out in a single ascending and multiple ascending dose study designs. We assessed Phase II therapeutic efficacy on COVID-19 and general respiratory symptoms on days 0, 3, 5, 7, 10, and 14 on the predesigned case record form. Viremia was evaluated on day 0, day 5, and day 10.
Results
Dose-limiting toxicities were not reached with the doses, frequencies, and duration studied, thus confirming the formulation’s preliminary safety. General respiratory symptoms (p < 0.001), anosmia (p < 0.05), and dysgeusia (p < 0.001) benefited significantly with the use of EO blend nebulization compared to placebo. Symptomatic COVID-19 participants with mild disease did not show treatment benefits in terms of symptomatic relief (p = 1.0) and viremia clearance (p = 0.74) compared to the placebo. EO blend was found to be associated with the reduced evolution of symptoms in previously asymptomatic reverse transcription polymerase chain reaction (RT-PCR)-positive study participants (p = 0.034).
Conclusion
EO nebulization appears to be a safer add-on symptomatic relief approach for mild COVID-19. However, the direct antiviral action of the EO blend needs to be assessed with different concentrations of combinations of individual phytochemicals in the EO blend.
【저자키워드】 COVID-19, Efficacy, Safety, Eucalyptus oil, Peppermint oil, Tea tree oil, Symptomatic relief, 【초록키워드】 Treatment, coronavirus disease, Evolution, clinical trial, Open-label, Toxicity, Symptom, Steroids, Anosmia, Randomized, Asymptomatic, Viremia, symptomatic, Mild, Placebo, reverse transcription, Combination, Concentration, phase, Therapeutic benefit, frequencies, therapeutic efficacy, participant, respiratory symptom, doses, antiviral action, clearance, Inconclusive, approach, objective, benefit, polymerase chain, Result, produced, carried, significantly, evaluated, reduced, appear, reached, study participant, multiple ascending dose, with mild disease, 【제목키워드】 clinical trial, Mild, exploratory, essential oil,