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Randomized Controlled Trial
. 2024 Feb 24;14(1):4532.
doi: 10.1038/s41598-024-54843-x.

Utilizing the sublingual form of squalene in COVID-19 patients: a randomized clinical trial

Mahmoud Ebrahimi  1 , Nafiseh Farhadian  2 , Sara Saffar Soflaei  3 , Alireza Amiri  4 , Davoud Tanbakuchi  5 , Rozita Khatamian Oskooee  6 , Mohammad Karimi  6
Affiliations
Randomized Controlled Trial

Utilizing the sublingual form of squalene in COVID-19 patients: a randomized clinical trial

Mahmoud Ebrahimi et al. Sci Rep. .

Abstract

In this study, the efficacy of sublingual squalene in decreasing the mortality rate among patients with COVID-19 was investigated. Squalene was extracted from pumpkin seed oil with a novel method. Then, the microemulsion form of squalene was prepared for sublingual usage. In the clinical study, among 850 admitted patients, 602 eligible COVID-19 patients were divided in two groups of control (N = 301) and cases (N = 301) between Nov 2021 and Jan 2022. Groups were statistically the same in terms of age, sex, BMI, lymphocyte count on 1st admission day, hypertension, chronic kidney disease, chronic respiratory disease, immunosuppressive disease, and required standard treatments. The treatment group received five drops of sublingual squalene every 4 h for 5 days plus standard treatment, while the control group received only standard treatment. Patients were followed up for 30 days after discharge from the hospital. The sublingual form of squalene in the microemulsion form was associated with a significant decrease in the mortality rate (p < 0.001), in which 285 (94.7%) cases were alive after one month while 245 (81.4%) controls were alive after 1 month of discharge from the hospital. In addition, squalene appears to be effective in preventing re-hospitalization due to COVID-19 (p < 0.001), with 141 of controls (46.8%) versus 58 cases (19.3%). This study suggests sublingual squalene in the microemulsion as an effective drug for reducing mortality and re-hospitalization rates in COVID-19 patients.Trial Registration Number: IRCT20200927048848N3.

Keywords: COVID-19; Early treatment; Mortality rate; Re-hospitalization; SARS-COV-2; Squalene.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Screening, enrollment, randomization, and clinical protocol.
Figure 2
Figure 2
(a) FID‐GC chromatogram diagram for extracted squalene at 3250 ppm, (b) FID‐GC chromatogram diagram for standard squalene at 6000 ppm (incident diagram shows the calibration curve), (c) TEM image, and (d) DLS diagram, of the sublingual form of SQ in microemulsion form.
Figure 3
Figure 3
The risk of re-hospitalization due to COVID-19 for each variable (*p-value between 0.01 and 0.05, **p-value between 0.05 and 0.001, and ***p-value less than 0.001).
Figure 4
Figure 4
The risk of death for each variable (*p-value between 0.01 and 0.05, **p-value between 0.05 and 0.001, and ***p-value less than 0.001).
Figure 5
Figure 5
Histogram of hospital discharge for (a) the standard treatment group and (b) the SQ plus standard treatment group.
Figure 6
Figure 6
Impact of various parameters on the number of hospitalization days of COVID-19 patients.
See this image and copyright information in PMC

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