Table 1

Patient and baseline characteristics from the intention-to-treat analysis

VariableLevelTotal (n=55)Placebo (n=28)Famotidine (n=27)P value*
Patients’ characteristics
Age (year)35.0±20.031.5±13.035.0±18.00.162
GenderFemale35 (63.6%)18 (64.3%)17 (63.0%)0.919
Male20 (36.4%)10 (35.7%)10 (37.0%)
RaceAmerican Indian or Alaskan Native1 (1.8%)0 (0.0%)1 (3.7%)0.862
Black or African American18 (32.7%)10 (35.7%)8 (29.6%)
More than one race12 (21.8%)7 (25.0%)5 (18.5%)
Unknown/not reported2 (3.6%)1 (3.6%)1 (3.7%)
White22 (40.0%)10 (35.7%)12 (44.4%)
EthnicityHispanic or Latino14 (25.5%)5 (17.9%)9 (33.3%)0.386
Not Hispanic or Latino22 (40.0%)13 (46.4%)9 (33.3%)
Unknown/not reported19 (34.5%)10 (35.7%)9 (33.3%)
COVID-19 symptom score at baseline†
Total symptom score18.0±11.018.0±13.018.0±10.00.985
History of present illness
Symptomatic days prior to randomisation4.0±3.04.0±2.04.0±3.00.363
Vital signs at baseline‡
BMI (kg/m2)27.33±7.7825.43±8.2828.93±6.690.149
Temperature (°F)98.30±0.8098.30±0.8098.50±0.770.253
Heart rate (bpm)88.0±19.087.0±23.089.0±16.50.385
SpO2 (%)99.0±2.099.0±3.099.0±1.50.992
FEV1/FVC0.88±0.230.88±0.190.88±0.250.614
  • For the continuous variable, median±IQR was reported.

  • *For categorical variables, p values were based on χ2 test with exact p value from Monte Carlo simulation; for the continuous variable, the p value was based on Wilcoxon rank sum test.

  • †Reason of missing data: IRB013 in placebo group, IRB041 and IRB052 in famotidine group withdrew early without baseline symptom scores.

  • ‡Reason of missing data: IRB013 in placebo group, IRB041, IRB044, IRB052 in famotidine group withdrew early/were lost to follow-up without baseline vitals completed.

  • BMI, body mass index.