Table 4.
Characteristics and Cox regression model on the fatal outcome of patients starting RDV therapy in complicated phase with steroid administration and matched controls
| Parameter | Patients undergoing complicated phase* | |||||
|---|---|---|---|---|---|---|
| RDV cases (n = 260) |
Matched controls (n = 260) |
Univariate analysis | Multivariable analysis | |||
| % (no. ± SD) | % (no. ± SD) | HR (95%-CI) | p-value | aHR (95%-CI) | p-value | |
| Age | ||||||
| 18–45 years | 15.4 (40 ± 0) | 15.4 (40 ± 0) | *** | *** | *** | *** |
| 46–65 years | 36.5 (95 ± 0) | 36.5 (95 ± 0) | *** | *** | *** | *** |
| 66–85 years | 41.9 (109 ± 0) | 41.9 (109 ± 0 | *** | *** | *** | *** |
| > 85 years | 6.2 (16 ± 0) | 6.2 (16 ± 0) | *** | *** | *** | *** |
| Gender | ||||||
| Male | 66.5 (173 ± 0) | 66.5 (173 ± 0) | *** | *** | *** | *** |
| Female | 33.5 (87 ± 0) | 33.5 (87 ± 0) | *** | *** | *** | *** |
| Comorbidities** | ||||||
| Hypertension | 49.9 (130 ± 1) | 48.1 (125 ± 5) | *** | *** | *** | *** |
| Chronic heart failure | 5.6 (15 ± 1) | 5.9 (15 ± 3) | *** | *** | *** | *** |
| Coronary heart disease | 17.7 (46 ± 1) | 20.3 (53 ± 4) | *** | *** | *** | *** |
| Other cardiovascular disease | 18.0 (47 ± 1) | 21.0 (55 ± 4) | 1.47 (0.78–2.76) | 0.789 | 1.16 (0.59–2.26) | 0.674 |
| Diabetes mellitus type 2 | 27.8 (72 ± 1) | 29.1 (76 ± 4) | *** | *** | *** | *** |
| Chronic pulmonary disease | 20.5 (53 ± 1) | 18.3 (48 ± 5) | *** | *** | *** | *** |
| Chronic kidney disease | 9.0 (23 ± 1) | 10.2 (26 ± 3) | *** | *** | *** | *** |
| Oncological disease | 14.5 (38 ± 1) | 12.0 (31 ± 4) | *** | *** | *** | *** |
| Chronic liver disease | 4.0 (10 ± 1) | 1.9 (5 ± 1) | 1.30 (0.28–6.05) | 0.977 | 1.50 (0.30–7.66) | 0.627 |
| BMI | ||||||
| < 18,5 kg/m2 | 2.0 (5 ± 1) | 2.3 (6 ± 2) | *** | *** | *** | *** |
| 18,5–24,9 kg/m2 | 23.7 (62 ± 4) | 23.2 (60 ± 6) | *** | *** | *** | *** |
| 25–29,9 kg/m2 | 31.9 (83 ± 5) | 32.8 (85 ± 8) | *** | *** | *** | *** |
| > 30 kg/m2 | 42.4 (110 ± 4) | 41.8 (109 ± 7) | *** | *** | *** | *** |
| Smoking history | ||||||
| Active smoker | 21.7 (57 ± 5) | 18.6 (48 ± 7) | 1.10 (0.55–2.20) | 0.977 | 1.12 (0.56–2.27) | 0.747 |
| Former smoker | 20.6 (53 ± 5) | 18.9 (49 ± 5) | 1.02 (0.40–2.63) | 0.977 | 0.98 (0.38–2.55) | 0.968 |
| Non-smoker | 57.7 (150 ± 7) | 62.5 (162 ± 7) | Ref | Ref | Ref | Ref |
| Pre-existing immunosuppressive therapy** | ||||||
| Immunosuppressive therapy | 7.2 (19 ± 1) | 9.2 (24 ± 3) | 1.56 (0.66–3.65) | 0.789 | 1.48 (0.61–3.59) | 0.392 |
| Course of SARS-CoV-2 infection | ||||||
| Fatal outcome | 8.8 (23 ± 0) | 16.9 (44 ± 4) | ||||
| Phase* at first positive SARS-CoV-2 detection | ||||||
| Uncomplicated phase | 40.8 (106 ± 0) | 40.8 (106 ± 0) | *** | *** | *** | *** |
| Complicated phase | 59.2 (154 ± 0) | 59.2 (154 ± 0) | *** | *** | *** | *** |
| Critical phase | 0.0 (0 ± 0) | 0.0 (0 ± 0) | *** | *** | *** | *** |
| Recovery phase | 0.0 (0 ± 0) | 0.0 (0 ± 0) | *** | *** | *** | *** |
| Dead | 0.0 (0 ± 0) | 0.0 (0 ± 0) | *** | *** | *** | *** |
| COVID-19 treatment** | ||||||
| Remdesivir | 100.0 (260 ± 0) | 0.0 (0 ± 0) | 0.50 (0.29–0.87) | 0.182 | 0.50 (0.29–0.88) | 0.021 |
|
Steroids > 0.5 mg/kg prednisolone equivalents in the critical phase of disease |
17.0 (44 ± 0) | 12.6 (32 ± 3) | *** | *** | *** | *** |
| Convalescent plasma | 1.1 (3 ± 0) | 1.2 (3 ± 1) | 1.52 (0.21–11.1) | 0.977 | 1.40 (0.18–11.11) | 0.753 |
| Other COVID-19 therapy | 3.9 (10 ± 0) | 2.1 (6 ± 2) | 1.03 (0.17–6.16) | 0.977 | 1.02 (0.15–6.85) | 0.983 |
| Anticoagulants | ||||||
| Therapeutic anticoagulation | 34.0 (88 ± 1) | 35.3 (92 ± 5) | 1.29 (0.56–2.97) | 0.977 | 1.36 (0.57–3.27) | 0.494 |
| Prophylactic anticoagulation | 56.3 (146 ± 1) | 49.8 (130 ± 6) | 0.60 (0.26–1.42) | 0.789 | 0.68 (0.28–1.62) | 0.384 |
| No anticoagulation | 9.7 (25 ± 0) | 14.9 (39 ± 5) | Ref | Ref | Ref | Ref |
| Time of first positive SARS-CoV-2 detection | ||||||
| First phase of COVID-19 pandemic | 12.7 (33 ± 0) | 13.2 (34 ± 3) | *** | *** | *** | *** |
| Second phase of COVID-19 pandemic | 67.3 (175 ± 0) | 66.3 (172 ± 4) | *** | *** | *** | *** |
| Third phase of COVID-19 pandemic | 20.0 (52 ± 0) | 20.5 (53 ± 3) | *** | *** | *** | *** |
Data are shown after multiple imputations, selection of patients undergoing the complicated phase of disease and matching by age category, gender, phase at first positive SARS-CoV-2 detection, hypertension, chronic heart failure, coronary heart disease, diabetes mellitus type 2, chronic pulmonary disease, chronic kidney disease, oncological disease, body mass index (BMI), interval of the pandemic and use of steroids in the critical phase of the disease. Distribution of factors is pooled among the imputed data and reported as a mean with a standard deviation rounded to integers. P value of univariable analysis after correction for multiple comparisons. First phase of the COVID-19 pandemic: January 2020-September 2020; second phase of COVID-19 pandemic: October 2020-Febuary 2021; third phase of COVID-19 pandemic: March 2021-December 2021; other COVID-19 therapy: IL-6R inhibitors, JAK-inhibitors or IL-1R inhibitors; other cardiovascular disease: aortic stenosis, AV block, carotic arterial disease, peripheral vascular disease and arterial fibrillation. n.a.: excluded due to model quality. *According to LEOSS (Figure S1). **No reference indicated in binary variables. ***Matching variables excluded from regression analysis