The results of a unique dietary supplement (nutraceutical formulation) used to treat the symptoms of long-haul COVID

Abstract

Long-COVID is a syndrome characterized by debilitating symptoms that persist over 3 months after infection with the SARS-CoV-2 virus. It affects 15 to 33% of COVID-19 recovered patients and has no dedicated treatment. First, we found that β-caryophyllene and pregnenolone have a significant synergistic effect in the resolution of LPS-induced sepsis and inflammation in mice. Then we combined these two compounds with seven others and designed a unique dietary supplement formulation to alleviate long COVID inflammatory and neurological disorders. We performed a one-arm open-labeled study at a single site with 51 eligible patients from 18 states. Each participant recorded the severity level of 12 symptoms (including fatigue, weakness, cardiac and neurological symptoms, shortness of breath, gastrointestinal disorders, ageusia or anosmia, anxiety, joint pain, rash, cough, and insomnia) at baseline, 2- and 4-week time points. On average, all the symptoms were significantly milder after 2 weeks, with further improvement after 4 weeks. Importantly, each symptom was significantly attenuated in 72 to 84% of the participants. There were no significant adverse effects. Our data indicate that the use of this nutraceutical product is a safe and significantly efficient option to reduce multiple symptoms of long COVID.

Keywords: CB2 agonists; cannabinoids; dietary (food) supplements; immunology and inflammation; long-COVID-19.

FIGURE 1

All groups were injected with LPS 25 μg/g. Mice were pre-treated with β-caryophyllene (BCP, 25 mg/kg) or Pregnenolone (Preg, 10 mg/kg) 24 and 12 h before LPS injection and then every 12 h. N = 7. ****p < 0.0001, 2-way ANOVA between βCP and Controls.

FIGURE 2

All groups were injected with LPS 25 μg/g. Mice were pre-treated with β-caryophyllene (BCP, 25 mg/kg) and Pregnenolone (Preg, 10 mg/kg) 24 and 12 h before LPS injection and then every 12 h. N = 7. ****p < 0.0001, 2-way ANOVA for disease progression; *p = 0.0152, Log-rank (Mantel-Cox) test for survival.

FIGURE 3

Survey-based scoring by participants at the intake to the trial (baseline), 2 and 4 weeks while taking the supplement. N = 51. Dunnett’s multiple comparisons test, p < 0.0001 in 2 and 4 weeks for the effect of the supplement on all the symptoms (vs. baseline). ^****p < 0.006 paired t-test, at 2 weeks vs. baseline and 4 weeks vs. baseline for each symptom.

FIGURE 4

Percentage of participants reporting an improvement, no change or worsening for each symptom at week 4 relative to baseline. “Global reported” is the score given by each participant on general feeling. “Global calculated” is the average of all the scores for each symptom.