Table 2 Primary and secondary outcomes in three groups.

From: Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial

Group, No. (%)

mITT

PPS

120 mg/day CEP

60 mg/day CEP

Placebo

120 mg/day CEP

60 mg/day CEP

Placebo

No.

65

68

55

57

52

43

Primary outcome, time to negative

Outcome event (%)

65 (100)

68 (100)

55 (100)

57 (100)

52 (100)

43 (100)

RMST (95%CI), days*

5.71 (5.00,6.42)

5.01 (4.37, 5.66)

5.78 (4.88, 6.68)

5.63 (4.86, 6.41)

4.85 (4.12, 5.58)

5.72 (4.69, 6.75)

Difference of RMST (95%CI)

-0.07 (-1.12, 1.07)

-0.77(-1.88, 0.34)

-

-0.09(-1.38, 1.20)

-0.87(-2.14, 0.39)

-

Hazard Ratio (95%CI)†

1.10 (0.76, 1.60)

1.40 (0.97, 2.01)

-

1.11 (0.73, 1.68)

1.56 (1.03,2.37)

-

P value††

0.606

0.072

-

0.619

0.035

-

Secondary outcomes

Patients developed to pneumonia or severe COVID-19 — no.(%)

0(0)

0(0)

0(0)

0(0)

0(0)

0(0)

SARS-CoV-2 returned to positive after turning negative — no.(%)

2 (3.1)

1 (1.5)

3 (5.5)

2 (3.5)

1 (1.9)

3 (7.0)

Hospitalization for COVID-19 — no.(%)

0(0)

0(0)

0(0)

0(0)

0(0)

0(0)

  1. * Time to negative was the time from randomization to negative nasopharyngeal swab, it was evaluated by RMST.
  2. † Hazard ratio evaluated by Cox proportional hazards model was primary analysis, adjusted for underlying chronic disease, age (> 60 year or ≤ 60 year), gender, symptoms, days from first nucleic acid test to randomization.
  3. †† p value was reported from adjusted cox regression.