Table 1.
Cohort demographics and associated metadata
| Overall | GI symptoms at enrollment |
Standardized difference | ||
|---|---|---|---|---|
| Yes | No | |||
| n | 111 | 54 | 57 | |
| Age, median (IQR) | 36 (29–51) | 36 (29–49) | 37 (30–53) | 0.05 |
| Female, n (%) | 46 (41%) | 26 (48%) | 20 (35%) | −0.27 |
| BMI (kg/m2), median (IQR) | 27.7 (24.8–31.8) | 28.2 (25.0–32.1) | 27.4 (24.7–30.5) | −0.25 |
| Race/Ethnicity, n (%) | ||||
| Hispanic | 72 (65%) | 38 (70%) | 34 (60%) | −0.22 |
| White | 28 (25%) | 12 (22%) | 16 (28%) | 0.13 |
| Asian | 4 (4%) | 3 (6%) | 1 (2%) | −0.2 |
| Unknown | 6 (5%) | 1 (2%) | 5 (9%) | 0.31 |
| Symptomatology | ||||
| Asymptomatic at enrollment, n (%) | 8 (7%) | 0 (0%) | 8 (14%) | 0.56 |
| Duration of symptoms in days prior to randomization, median (IQR) | 5 (4–7) | 6 (5–8) | 5 (3–7) | −0.61 |
| GI symptoms at enrollment | ||||
| Any GI symptom | 54 (49%) | 54 (100%) | 0 (0%) | |
| Abdominal pain | 13.0 (12%) | 13.0 (24%) | 0 (0%) | −0.8 |
| Diarrhea | 29.0 (26%) | 29.0 (54%) | 0 (0%) | −1.53 |
| Nausea | 31.0 (28%) | 31.0 (57%) | 0 (0%) | −0.8 |
| Vomiting | 5.0 (5%) | 5.0 (9%) | 0 (0%) | −0.45 |
| Other symptoms at enrollment | ||||
| Body aches (myalgias) | 59.0 (53%) | 42.0 (78%) | 17.0 (30%) | −1.09 |
| Chest pain/pressure | 21.0 (19%) | 15.0 (28%) | 6.0 (11%) | −0.45 |
| Chills | 44.0 (40%) | 32.0 (59%) | 12.0 (21%) | −0.84 |
| Cough | 62.0 (56%) | 38.0 (70%) | 24.0 (42%) | −0.59 |
| Decreased smell | 51.0 (46%) | 34.0 (63%) | 17.0 (30%) | −0.7 |
| Fatigue | 68.0 (61%) | 43.0 (80%) | 25.0 (44%) | −0.78 |
| Fever (>99.5°F) | 10 (9%) | 4 (7%) | 6 (11%) | 0.11 |
| Headache | 62.0 (56%) | 38.0 (70%) | 24.0 (42%) | −0.59 |
| Joint pain | 36.0 (32%) | 25.0 (46%) | 11.0 (19%) | −0.6 |
| Shortness of breath | 28.0 (25%) | 17.0 (32%) | 11.0 (19%) | −0.28 |
| Sore throat | 43.0 (39%) | 27.0 (50%) | 16.0 (28%) | −0.46 |
| Rash | 6.0 (5%) | 4.0 (7%) | 2.0 (4%) | −0.17 |
| Runny nose | 24.0 (22%) | 16.0 (30%) | 8.0 (14%) | −0.38 |
| Laboratory values at enrollment, median (IQR) | ||||
| Absolute lymphocyte count (cells/μL) | 1.5 (1.2–2.2) | 1.4 (1.1–1.9) | 1.6 (1.2–2.3) | 0.33 |
| Alanine aminotransferase (IU/L) | 30.0 (22.0–48.5) | 31.5 (22.0–47.8) | 28.0 (22.0–50.0) | 0.07 |
| Aspartate aminotransferase (IU/L) | 30.0 (25.0–39.0) | 32.5 (26.0–41.0) | 29.0 (24.0–34.0) | −0.03 |
| Seropositivity at enrollment, n (%) | 46 (41%) | 22 (41%) | 24 (42%) | 0.03 |
| White blood cell count (cells/μL) | 5.5 (4.2–7.1) | 5.4 (3.8–7.1) | 5.8 (4.7–7.1) | 0.18 |