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Table 2 Efficacy endpoint comparisons between active (2-DG) and standard-of-care groups

From: 2-deoxy-d-glucose as an adjunct to standard of care in the medical management of COVID-19: a proof-of-concept and dose-ranging randomised phase II clinical trial

  

2-DG 63 mg + SOC

SOC1

2-DG 90 mg + SOC

2-DG 126 mg + SOC

SOC2

Pooled SOC

(SOC1 + SOC2)

Time (days) to achieve SpO2 ≥ 94% (on two consecutive assessments on room air, at sea level)

N

22

22

22

21

22

44

Median (days)

5

5

2.5

3

5

5

HR (95% CI)a

1.277 (0.658, 2.477)

2.3 (1.14, 4.642)

0.975 (0.494, 1.925)

P-value a

0.4698

0.0201

0.9415

Time (days) to discharge

Median (days)

12

11

8

11

10

10

HR (95% CI)a

0.791 (0.416, 1.504)

2.238 (1.065, 4.703)

0.679 (0.334, 1.38)

P-value a

0.4746

0.0336

0.2847

Time (days) to clinical recoveryb

Median (days)

4.5

5

3

4

6

5

HR (95% CI)a

0.985 (0.526, 1.846)

3.837 (1.853, 7.944)

1.881 (0.922, 3.838)

P-value a

0.9629

0.0003

0.0824

Time (days) to vital signs normalisationc

Median (days)

7

7

5

10

8

7

HR (95% CI)a

0.889 (0.472, 1.674)

4.341 (1.669, 11.294)

1.024 (0.418, 2.511)

P-value

0.7162

0.0026

0.958

Time (days) to achieve 2 points improvement on WHO clinical progression scale

Median (days)

11

10.5

5

5

6

8

HR (95% CI)a

0.624 (0.318, 1.224)

1.763 (0.924, 3.363)

1.183 (0.63, 2.221)

P-valuea

0.1702

0.0852

0.6021

Time (days) to achieve 1 point improvement on WHO clinical progression scale

Median (days)

5.5

6

4

3

5

5

HR (95% CI) a

1.414 (0.71, 2.818)

1.483 (0.78, 2.822)

1.301 (0.697, 2.427)

P-valuea

0.3247

0.2297

0.409

  1. CI confidence interval, 2-DG 2-deoxy-d-glucose, HR hazard ratio, SOC standard of care, SOC1 SOC in Part A of the study, SOC2 SOC in Part B of the study, WHO World Health Organization
  2. aEach 2-DG + SOC group was compared with its respective SOC group, in Parts A and B of the study. The 63 mg group was compared with SOC1, and the 90 mg and 126 mg groups were compared with SOC2
  3. bTime to clinical recovery is a composite endpoint of number of days to achieving and maintaining blood oxygen saturation of ≥ 94% on room air and the number of days to achieving symptom severity score of ≤ 1 (on a 5-point Likert-type scale) for all COVID-19 associated symptoms, after start of study treatment
  4. cTime to vital signs normalisation was defined as the earliest date when all the following vital signs parameters were satisfied: body temperature < 98.9 ℉, respiratory rate < 20 breaths per min, blood oxygen saturation (SpO2) > 95% on room air and heart rate < 90 bpm after start of study treatment