Table 1.
Baseline characteristics of study participants.
| Treatment arm | |||
|---|---|---|---|
| Lambda (n = 60) | Placebo (n = 60) | Overall (n = 120) | |
| Age in years, median (range) | 37 (18–66) | 34 (20–71) | 36 (18–71) |
| Female, n (%) | 24 (40.0%) | 26 (43.3%) | 50 (41.7%) |
| Race/Ethnicity, n (%) | |||
| Latinx | 34 (56.7%) | 41 (68.3%) | 75 (62.5%) |
| White | 18 (30.0%) | 15 (25.0%) | 33 (27.5%) |
| Asian | 3 (5.0%) | 4 (6.7%) | 7 (5.8%) |
| Native Hawaiian or other Pacific Islander | 2 (3.3%) | 0 (0%) | 2 (1.7%) |
| Unknown | 2 (3.3%) | 0 (0%) | 2 (1.7%) |
| More than one race | 1 (1.7%) | 0 (0%) | 1 (0.8%) |
| BMI (kg/m2), median (IQR) | 27.6 (25.4–31.1) | 28.5 (24.8–32.3) | 27.7 (24.9–32.0) |
| Comorbid conditions | |||
| Hypertension | 9 (15.0) | 5 (8.3) | 14 (11.7) |
| Diabetes | 4 (6.7) | 8 (13.3) | 12 (10.0) |
| Asthma | 2 (3.3) | 2 (3.3) | 4 (3.3) |
| Heart disease | 3 (5.0) | 1 (1.7) | 4 (3.3) |
| Concomitant medications | |||
| Antihypertensive | 9 (15.0) | 5 (8.3) | 14 (11.7) |
| Oral hypoglycemic | 4 (6.7) | 8 (13.3) | 12 (10.0) |
| Insulin | 0 (0.0) | 1 (1.7) | 1 (0.8) |
| Aspirin | 1 (1.7) | 2 (3.3) | 3 (2.5) |
| Statin | 3 (5.0) | 5 (8.3) | 8 (6.7) |
| Albuterol | 2 (3.3) | 0 (0.0) | 2 (1.7) |
| Asymptomatic at baseline, n (%) | 6 (10.0%) | 2 (3.3%) | 8 (6.7%) |
| Duration of symptoms in days prior to randomization, median (IQR) a | 4 (3–6) | 5 (3–5) | 5 (3–6) |
| Symptoms at baseline, n (%) | |||
| Fatigue | 33 (55%) | 42 (70%) | 75 (62.5%) |
| Cough | 33 (55.0%) | 36 (60.0%) | 69 (57.5%) |
| Headache | 29 (48.3%) | 36 (60%) | 65 (54.2%) |
| Myalgias | 29 (48.3%) | 34 (56.7%) | 63 (52.5%) |
| Decreased taste or smell | 25 (41.7%) | 32 (53.3%) | 57 (47.5%) |
| Chills | 22 (36.7%) | 27 (45%) | 49 (40.8%) |
| Sore throat | 22 (36.7%) | 23 (38.3%) | 45 (37.5%) |
| Joint pain | 19 (31.7%) | 19 (31.7%) | 38 (31.7%) |
| Diarrhea | 16 (26.7%) | 18 (30%) | 34 (28.3%) |
| Nausea | 11 (18.3%) | 23 (38.3%) | 34 (28.3%) |
| Shortness of breath | 16 (26.7%) | 16 (26.7%) | 32 (26.7%) |
| Chest pain/pressure | 14 (23.3%) | 13 (21.7%) | 27 (22.5%) |
| Runny nose | 10 (16.7%) | 16 (26.7%) | 26 (21.7%) |
| Abdominal pain | 7 (11.7%) | 7 (11.7%) | 14 (11.7%) |
| Rash | 4 (6.7%) | 5 (8.3%) | 9 (7.5%) |
| Vomiting | 1 (1.7%) | 5 (8.3%) | 6 (5%) |
| Vital signs at enrollment | |||
| Temperature 99.5F+, n (%) | 6 (10.0%) | 7 (11.7%) | 13 (10.8%) |
| Oxygen saturation, median (IQR) | 98 (2.5) | 99 (3) | 98 (3) |
| Baseline laboratory values, median (IQR) | |||
| White blood cell (WBC) count, cells/µl | 5.5 (4.3–6.8) | 5.6 (4.0–7.5) | 5.5 (4.1–7.1) |
| Absolute lymphocyte count (ALC), cells/µl | 1.5 (1.2–1.9) | 1.5 (1.2–2.3) | 1.5 (1.2–2.2) |
| Aspartate aminotransferase, IU/L | 31 (26–41) | 30 (25–39.3) | 30 (25–41) |
| Alanine aminotransferase, IU/L | 32.5 (21–52.3) | 30.5 (23–47.5) | 31.5 (22–50.3) |
| Baseline oropharyngeal SARS-CoV-2 cycle threshold, median (IQR)b | 30.9 (26.4–33.8) | 29.3 (26.4–34.3) | 30.3 (26.4–34.3) |
| Baseline Log10 Viral Load, median (IQR)b | 4.2 (3.3–5.5) | 4.7 (3.2–5.5) | 4.4 (3.2–5.5) |
| Baseline SARS-CoV-2 IgG seropositivity, n (%) | 21 (35.0%) | 28 (46.7%) | 49 (40.8%) |
| Sum of risk factors, median (IQR) | 3 (2–3) | 3 (2–4) | 3 (2–3) |
Sum of risk factors is defined as the number of relevant severe disease risk factors present at baseline (presence of either temperature of 99.5F+, cough, or shortness of breath; age 60+; male sex; Black race; Latinx ethnicity; BMI 30+; ALC < 1000; ALT 94+). Source data available at https://purl.stanford.edu/hc972ys6733.
IQR inner quartile range, ASD absolute standardized difference.
aAmong n = 103 participant who reported symptoms prior to randomization (n = 48 in lambda and n = 55 in placebo).
bAmong n = 87 participants with detectable OP virus (n = 44 in lambda and n = 43 in placebo).