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Table 2 Comparison of the primary and secondary endpoints

From: Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial

Time to the resolution of symptoms

LHQW treatment group

Placebo group

HR (95%CI)

P value

No. (%) of responders

Duration (days), Median (95% CI)

No. (%) of responders

Duration (days), Median (95% CI)

Primary endpoint (Full-analysis set)

 Nine major symptoms *

356 (86.8%)

4.0 (3.8–4.8)

291 (71.9%)

6.7 (5.9–7.9)

1.63 (1.39–1.90)

< 0.001

Primary endpoint (Per-protocol set)

 Nine major symptoms *

349 (87.9%)

4.0 (3.8–4.7)

283 (73.1%)

6.6 (5.8–7.7)

1.64 (1.40–1.92)

< 0.001

Secondary endpoints (full-analysis set)

 Stuffy or runny nose

297 (94.9%)

2.8 (2.3–3.0)

278 (87.1%)

3.7 (2.9–4.0)

1.43 (1.21–1.69)

< 0.001

 Sore throat

318 (96.4%)

2.0 (1.9–2.4)

309 (90.4%)

2.6 (2.2–3.0)

1.43 (1.22–1.67)

< 0.001

 Cough

318 (90.1%)

3.2 (2.9–3.7)

259 (73.6%)

4.9 (4.5–5.9)

1.68 (1.43–1.99)

< 0.001

 Shortness of breath

77 (95.1%)

2.0 (1.1–2.8)

81 (89.0%)

2.7 (1.7–2.9)

1.19 (0.87–1.62)

0.279

 Low energy or tiredness

237 (96.0%)

1.3 (1.1–1.8)

232 (91.7%)

1.9 (1.7–2.2)

1.40 (1.17–1.68)

< 0.001

 Myalgia

216 (97.7%)

1.5 (1.2–1.8)

203 (92.3%)

2.0 (1.6–2.2)

1.40 (1.15–1.70)

< 0.001

 Headache

194 (96.5%)

1.4 (1.1–1.7)

197 (95.6%)

1.8 (1.4–1.9)

1.15 (0.94–1.40)

0.180

 Chills or shivering

109 (97.3%)

1.0 (0.9–1.3)

109 (94.8%)

1.3 (1.0–1.6)

1.23 (0.95–1.61)

0.120

 Feeling hot or feverish

184 (97.9%)

1.0 (1.0–1.3)

188 (94.5%)

1.3 (1.0–1.7)

1.31 (1.07–1.60)

0.010

 Normalized body temperature within 2 weeks

80 (98.8%)

1.0 (0.8–1.4)

73 (98.6%)

1.6 (1.3–1.9)

1.37 (1.00–1.89)

0.052

  1. *The nine major symptoms consisted of stuffy or runny nose, sore throat, cough, shortness of breath, low energy or tiredness, myalgia, headache, chills or shivering, feeling hot or feverish which occurred within 12 hours prior to screening
  2. Responders denoted the patients who had a sustained improvement or resolution of the symptoms