A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2.

There is an urgent need for an oral drug for the treatment of mild to moderate outpatient SARS-CoV-2. Our preclinical and clinical study's aim was to determine the safety and preliminary efficacy of oral TQ Formula (TQF), in the treatment of outpatient SARS-CoV-2. In a double-blind, placebo-controlled phase 2 trial, we randomly assigned (1:1 ratio) non-hospitalized, adult (>18 years), symptomatic SARS-CoV-2 patients to receive oral TQF or placebo. The primary endpoints were safety and the median time-to-sustained-clinical-response (SCR). SCR was 6 days in the TQF arm vs. 8 days in the placebo arm (p = 0.77), and 5 days in the TQF arm vs. 7.5 days in the placebo arm in the high-risk cohort, HR 1.55 (95% CI: 0.70, 3.43, p = 0.25). No significant difference was found in the rate of AEs (p = 0.16). TQF led to a significantly faster decline in the total symptom burden (TSB) (p < 0.001), and a significant increase in cytotoxic CD8+ (p = 0.042) and helper CD4+ (p = 0.042) central memory T lymphocytes. TQF exhibited an in vitro inhibitory effect on the entry of five SARS-CoV-2 variants. TQF was well-tolerated. While the median time-to-SCR did not reach statistical significance; it was shorter in the TQF arm and preclinical/clinical signals of TQF activity across multiple endpoints were significant. Therefore, a confirmatory study is planned.

Comparison of baseline fat-related eating behaviors of Puerto Rican, Dominican, Colombian, and Guatemalan participants who joined a cholesterol education project.

OBJECTIVE: The objective is to compare baseline fat-related eating behaviors among Hispanic subgroups who joined a cholesterol education research project in New England. DESIGN: Participants attended baseline screenings as part of the study. They had their height, weight, and blood cholesterol measured and completed baseline surveys with demographic, risk factor, dietary, and psychosocial questions. PARTICIPANTS: A total of 370 Puerto Rican, 210 Colombian, 357 Dominican, and 102 Guatemalan subjects participated in the baseline. MAIN OUTCOME MEASURES: Dietary behavior was measured using the Food Habits Questionnaire (FHQ), which was originally developed to assess food choices and preparation patterns related to adopting a low-fat diet. Measures include FHQ fat summary scores (a reflection of total fat intake), fat behavior subscales, and individual fat-related behaviors. ANALYSIS: Analysis of variance was used to compare FHQ fat summary scores and multivariate analysis of variance was used to compare fat behavior scores and individual food item scores for the 4 Hispanic subgroups. Age and gender were covariates in the models. RESULTS: Puerto Rican participants had a significantly higher mean FHQ fat summary score than Dominicans and Guatemalans and a higher prevalence of many fat-related eating behaviors. Although there were some differences by subgroup, the 4 most prevalent fat-related behaviors were similar: cooking with fat/oil, eating higher-fat sweets, eating higher-fat snacks, and eating dinners with meat. CONCLUSIONS AND IMPLICATIONS: Future educational programs and materials for diverse Hispanic audiences in the northeastern United States should include the above issues; however, educational materials and programs ought to be tailored to individuals whenever possible. Efforts may need to focus on Puerto Ricans, who had a higher prevalence of many fat-related behaviors in this study.