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Table 2 Summary and analysis of the proportion of patients achieving sustained (≥ 48 h) symptom alleviation

From: Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19

 

All patients

< 2 Moderate/higher symptom severity at baseline

≥ 2 Moderate/higher symptom severity at baseline

Placebo

(N = 529)

Sotrovimab

(N = 528)

Placebo

(N = 237)

Sotrovimab

(N = 241)

Placebo

(N = 214)

Sotrovimab

(N = 218)

Day 7

Symptom alleviation status, n (%)

 Sustained (≥ 48 h) symptom alleviation

31 (6)

76 (14)

25 (11)

52 (22)

7 (3)

22 (10)

 Not sustained symptom alleviation

498 (94)

452 (86)

212 (89)

189 (78)

207 (97)

196 (90)

  Adjusted relative risk ratio (95% CI)

2.51 (1.69 to 3.72)

2.07 (1.33 to 3.21)

3.10 (1.36 to 7.07)

   p value

< 0.001

0.002

0.008

  Adjusted relative risk difference

9.99

13.46

8.72

Day 14

Symptom alleviation status, n (%)

 Sustained (≥ 48 h) symptom alleviation

104 (20)

164 (31)

62 (26)

96 (40)

36 (17)

63 (29)

 Not sustained symptom alleviation

425 (80)

364 (69)

175 (74)

145 (60)

178 (83)

155 (71)

  Adjusted relative risk ratio (95% CI)

1.59 (1.28 to 1.97)

1.52 (1.17 to 1.98)

1.72 (1.20 to 2.47)

  p value

< 0.001

0.002

0.004

  Adjusted relative risk difference

8.08

11.20

10.06

Day 21

Symptom alleviation status, n (%)

 Sustained (≥ 48 h) symptom alleviation

178 (34)

214 (41)

104 (44)

126 (52)

64 (30)

78 (36)

 Not sustained symptom alleviation

351 (66)

314 (59)

133 (56)

115 (48)

150 (70)

140 (64)

  Adjusted relative risk ratio (95% CI)

1.21 (1.03 to 1.41)

1.19 (0.99 to 1.43)

1.20 (0.92 to 1.57)

  p value

0.020

0.072

0.188

  Adjusted relative risk difference

4.37

6.31

4.61

  1. The analysis by symptom severity subgroup is based on data collected through Day 21, as shown in the end of study Week 24 database
  2. Data where symptom alleviation cannot be assessed due to a missing/incomplete questionnaire are imputed as no symptom alleviation
  3. Analysis was performed using a Poisson model, adjusting for region (Europe, North America, South America), duration of symptoms (≤ 3 days versus ≥ 4 days), age (≤ 70 versus > 70 years), and sex (male, female). For the analysis by symptom severity subgroup, a treatment by patient-reported symptom severity interaction term was added to the above model
  4. CI confidence interval