TABLE 1.
Key baseline data and outcomes
| Placebo (n=6) | Nezulcitinib | |||
| 1 mg (n=6) | 3 mg (n=7)# | 10 mg (n=6) | ||
| Baseline characteristics | ||||
| Sex, male | 3 (50.0) | 5 (83.3) | 4 (57.1) | 5 (83.3) |
| Age, years | 54.2±17.0 | 59.5±15.5 | 62.0±3.3 | 52.8±13.4 |
| Race, white | 5 (83.3) | 6 (100) | 7 (100) | 6 (100) |
| Country of enrolment | ||||
| Moldova | 3 | 6 | 6 | 3 |
| Ukraine | 2 | 0 | 0 | 2 |
| UK | 1 | 0 | 1 | 1 |
| Body mass index, kg·m−2 | 27.2±3.6 | 32.6±7.1 | 31.8±2.7 | 34.3±3.4 |
| Comorbidities | ||||
| Hypertension | 4 (66.7) | 6 (100) | 4 (57.1) | 3 (50.0) |
| Sleep apnoea | 1 (16.7) | 4 (66.7) | 3 (42.9) | 3 (50.0) |
| Diabetes mellitus | 3 (50.0) | 3 (50.0) | 3 (42.9) | 1 (16.7) |
| COVID-19 symptom duration, days, median (IQR) | 7.5 (3.0) | 6.5 (3.0) | 8.0 (4.0) | 7.5 (2.0) |
| SaO2/FIO2 ratio | 284.5±63.6 | 295.0±28.2 | 282.5±55.5 | 270.0±61.5 |
| Concomitant medication | ||||
| Dexamethasone | 5 (83.3) | 6 (100) | 7 (100) | 5 (83.3) |
| Heparin group¶ | 4 (66.7) | 6 (100) | 7 (100) | 6 (100) |
| Remdesivir | 1 (16.7) | 0 | 1 (14.3) | 1 (16.7) |
| Summary of TEAEs+ | ||||
| All TEAEs | 6 (100) | 5 (83.3) | 2 (28.6) | 5 (83.3) |
| Related to study treatment | 1 (16.7) | 2 (33.3) | 0 | 3 (50.0) |
| Clinical endpoints§ | ||||
| Change in SaO2/FIO2 from day 1 to 7 | −49.5±65.3 | 108.9±87.9 | 106.4±87.8 | 11.2±106.3 |
| Alive and respiratory failure-free on day 28 | 4 (66.7) | 5 (83.3) | 6 (85.7)ƒ | 6 (100) |
| Time to hospital discharge, days## | 22.5±6.4 | 18.8±6.8 | 15.3±6.7 | 15.2±4.4 |
| Clinical status OSƒ,¶¶ | ||||
| Day 7 | ||||
| 1 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 |
| 3 | 1 (16.7) | 0 | 1 (16.7) | 0 |
| 4 | 0 | 4 (66.7) | 2 (33.3) | 2 (33.3) |
| 5 | 2 (33.3) | 2 (33.3) | 3 (50.0) | 4 (66.7) |
| 6 | 0 | 0 | 0 | 0 |
| 7 | 3 (50.0) | 0 | 0 | 0 |
| 8 | 0 | 0 | 0 | 0 |
| Day 28ƒ | ||||
| 1 | 3 (50.0) | 5 (83.3) | 5 (83.3) | 5 (83.3) |
| 2 | 0 | 0 | 0 | 1 (16.7) |
| 3 | 0 | 0 | 0 | 0 |
| 4 | 1 (16.7) | 0 | 1 (16.7) | 0 |
| 5 | 0 | 0 | 0 | 0 |
| 6 | 0 | 0 | 0 | 0 |
| 7 | 0 | 0 | 0 | 0 |
| 8 | 2 (33.3) | 1 (16.7) | 0 | 0 |
Data are shown as mean±sd or n (%), unless otherwise specified. #: one patient discontinued the study due to subsequent negative PCR test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and was replaced but included in analyses as available data permitted. ¶: includes heparins, enoxaparin, bemiparin and nadroparin. +: including patients who received ≥1 dose of study drug analysed as treated. §: including all randomised patients analysed as randomised (intent-to-treat population). ƒ: the patient who discontinued the study due to negative PCR test for SARS-CoV-2 was known to be alive but with unknown clinical status at day 28. Thus, this patient was not counted as alive and respiratory failure-free and was not included in analyses of ordinal scale (OS) on days 7 and 28. ##: for patients who died or were still hospitalised on day 28, a time to discharge of 28 days was assigned. ¶¶: 8-point OS: 1, not hospitalised, no limitations on activities; 2, not hospitalised, but with limitation on activities and/or requiring home oxygen; 3, hospitalised, not requiring supplemental oxygen and no longer requiring ongoing medical care (including hospitalisation for infection control); 4, hospitalised, not requiring supplemental oxygen but requiring ongoing medical care (whether related or not to coronavirus disease 2019 (COVID-19)); 5, hospitalised, requiring supplemental oxygen; 6, hospitalised, on noninvasive ventilation or high-flow oxygen devices; 7, hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8, death. IQR: interquartile range; SaO2/FIO2: ratio of oxygen saturation measured by pulse oximetry to fraction of inspired oxygen; TEAE: treatment-emergent adverse event.