The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study
Abstract
:1. Introduction
2. Material and Methods
2.1. Study Patients
2.2. Study Design
2.3. Primary and Secondary Outcomes
2.4. Statistical Analysis
3. Results
3.1. Enrolled Patients and Baseline Characteristics
3.2. Primary Outcome
3.3. Secondary Outcomes
3.4. Independent Factors Associated with Oxygen-Free Days on Day 28
3.5. Adverse Events Associated with Regdanvimab Use
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | Total (n = 124) | Remdesivir Alone (n = 99) | Regdanvimab/ Remdesivir (n = 25) | p-Value | |
---|---|---|---|---|---|
Age (years) | 57.59 ± 12.24 | 56.64 ± 12.13 | 61.36 ± 12.20 | 0.085 | |
Age (years), distribution | 0.413 | ||||
20–29 | 2 (1.6) | 2 (2.0) | 0 (0.0) | ||
30–39 | 8 (6.5) | 8 (8.1) | 0 (0.0) | ||
40–49 | 18 (14.5) | 14 (14.1) | 4 (16.0) | ||
50–59 | 36 (29.0) | 29 (29.3) | 7 (28.0) | ||
60–69 | 47 (37.9) | 37 (37.4) | 10 (40.0) | ||
70–79 | 7 (5.6) | 6 (6.1) | 1 (4.0) | ||
80–89 | 6 (4.8) | 3 (3.0) | 3 (12.0) | ||
Sex | 1.000 | ||||
Male | 54 (43.5) | 43 (43.4) | 11 (44.0) | ||
Female | 70 (56.5) | 56 (56.6) | 14 (56.0) | ||
Body weight (kg) | 68.56 ± 12.68 | 67.66 ± 11.78 | 72.12 ± 15.52 | 0.116 | |
Height (cm) | 164.17 ± 8.52 | 164.35 ± 8.04 | 163.47 ± 10.34 | 0.645 | |
BMI (kg/m2) | 25.31 ± 3.40 | 24.94 ± 3.19 | 26.79 ± 3.83 | 0.014 | |
Race | 1.000 | ||||
Asian | 123 (99.2) | 98 (99.0) | 25 (100.0) | ||
White | 1 (0.8) | 1 (1.0) | 0 (0.0) | ||
Underlying diseases | |||||
Hypertension | 32 (25.8) | 25 (25.3) | 7 (28.0) | 0.779 | |
Diabetes | 16 (12.9) | 12 (12.1) | 4 (16.0) | 0.738 | |
Dyslipidemia | 20 (16.1) | 15 (15.2) | 5 (20.0) | 0.551 | |
Chronic heart disease | 3 (2.4) | 2 (2.0) | 1 (4.0) | 0.494 | |
Chronic lung disease | 3 (2.4) | 2 (2.0) | 1 (4.0) | 0.494 | |
Chronic kidney disease | 5 (4.0) | 4 (4.0) | 1 (4.0) | 1.000 | |
Chronic liver disease | 5 (4.0) | 3 (3.0) | 2 (8.0) | 0.264 | |
Rheumatologic disease | 2 (1.6) | 2 (2.0) | 0 (0.0) | 1.000 | |
Neurologic disease | 6 (4.8) | 5 (5.1) | 1 (4.0) | 1.000 | |
Psychiatiric disease | 2 (1.6) | 2 (2.0) | 0 (0.0) | 1.000 | |
Active malignancy | 3 (2.4) | 2 (2.0) | 1 (4.0) | 0.494 | |
Days from symptom onset | |||||
To admission | 2.90 ± 3.19 | 3.19 ± 3.14 | 1.76 ± 3.21 | 0.045 | |
To regdanvimab | NA | NA | 3.68 ± 3.00 | NA | |
To remdesivir | 5.17 ± 3.25 | 5.21 ± 3.29 | 5.00 ± 3.12 | 0.772 | |
Days from admission | |||||
To regdanvimab | NA | NA | 1.92 ± 2.08 | NA | |
To remdesivir | 2.27 ± 2.84 | 2.02 ± 2.89 | 3.24 ± 2.47 | 0.055 | |
Days from regdanvimab | |||||
To remdesivir | NA | NA | 1.32 ± 1.77 | NA | |
Respiratory support at the time of initiation of remdesivir | 0.460 | ||||
Oxygen with nasal prong or simple mask | 113 (91.1) | 89 (89.9) | 24 (96.0) | ||
Advanced respiratory support | 11 (8.9) | 10 (10.1) | 1 (4.0) | ||
Mask with reservoir bag | 2 (1.6) | 2 (2.0) | 0 (0.0) | ||
HFNC | 9 (7.3) | 8 (8.1) | 1 (4.0) | ||
NIV | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
Invasive ventilation | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
ECMO | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
FiO2 at the time of initiation of remdesivir | 0.34 ± 013 | 0.35 ± 0.14 | 0.30 ± 0.08 | 0.078 | |
SpO2/FiO2 ratio at the time of initiation of remdesivir | 297.46 ± 69.67 | 290.09 ± 69.76 | 326.63 ± 62.39 | 0.018 | |
SpO2/FiO2 ratio distribution at the time of initiation of remdesivir | 0.213 | ||||
0–99 | 3 (2.4) | 3 (3.0) | 0 (0.0) | ||
100–199 | 8 (6.5) | 7 (7.1) | 1 (4.0) | ||
200–299 | 39 (31.5) | 33 (33.3) | 6 (24.0) | ||
300–399 | 69 (55.6) | 54 (54.5) | 15 (60.0) | ||
400–499 | 5 (4.0) | 2 (2.0) | 3 (12.0) | ||
CXR score at the time of initiation of remdesivir | 5.16 ± 4.31 | 5.42 ± 4.42 | 4.16 ± 3.75 | 0.194 | |
Systemic corticosteroids use | 122 (98.4) | 97 (98.0) | 25 (100.0) | 1.000 | |
Dexamethasone | 121 (97.6) | 97 (98) | 24 (96.0) | ||
Prednisolone | 1 (0.8) | 0 (0.0) | 1 (4.0) |
Variables | Total (n = 124) | Remdesivir Alone (n = 99) | Regdanvimab/ Remdesivir (n = 25) | p-Value |
---|---|---|---|---|
Primary outcome | ||||
Oxygen-free days on day 28 | 0.003 | |||
Mean ± SD | 20.04 ± 7.33 | 19.36 ± 7.87 | 22.72 ± 3.66 | |
Median (IQR) | 22.0 (20.0–24.5) | 22.0 (19.0–24.0) | 23.0 (22.0–25.0) | |
Secondary outcomes | ||||
Oxygen-free days on day 14 | 0.074 | |||
Mean ± SD | 7.48 ± 4.15 | 7.14 ± 4.26 | 8.80 ± 3.43 | |
Median (IQR) | 8.0 (6.0–10.5) | 8.0 (5.0–10.0) | 9.0 (8.0–11.0) | |
Oxygen-free days on day 56 | 0.001 | |||
Mean ± SD | 46.85 ± 11.52 | 45.87 ± 12.59 | 50.72 ± 3.66 | |
Median (IQR) | 50.0 (48.0–52.5) | 50.0 (47.0–52.0) | 51.0 (50.0–53.0) | |
Oxygen off and live on day 14 | 104 (83.9) | 80 (80.8) | 24 (96.0) | 0.074 |
Oxygen off and live on day 28 | 116 (93.5) | 91 (91.9) | 25 (100.0) | 0.357 |
Oxygen off and live on day 56 | 119 (96.0) | 94 (94.9) | 25 (100.0) | 0.582 |
The highest FiO2 during treatment | 0.45 ± 0.24 | 0.48 ± 0.26 | 0.34 ± 0.15 | 0.001 |
The lowest SpO2/FiO2 ratio during treatment | 248.86 ± 89.43 | 237.05 ± 89.68 | 295.63 ± 72.74 | 0.003 |
The lowest SpO2/FiO2 ratio distribution during treatment | 0.087 | |||
0–99 | 15 (12.1) | 15 (15.2) | 0 (0.0) | |
100–199 | 17 (13.7) | 14 (14.1) | 3 (12.0) | |
200–299 | 41 (33.1) | 34 (34.3) | 7 (28.0) | |
300–399 | 50 (40.3) | 35 (35.4) | 15 (60.0) | |
400–499 | 1 (0.8) | 1 (1.0) | 0 (0.0) | |
The highest degree of respiratory support during treatment | 0.077 | |||
Oxygen with nasal prong or simple mask | 92 (74.2) | 70 (70.7) | 22 (88.0) | |
Advanced respiratory support | 32 (25.8) | 29 (29.3) | 3 (12.0) | |
Mask with Reservoir bag | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
HFNC | 20 (16.1) | 18 (18.2) | 2 (8.0) | |
NIV | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Invasive ventilation | 12 (9.7) | 11 (11.1) | 1 (4.0) | |
ECMO | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Changes in CXR | ||||
Days from the first scored CXR | 10.93 ± 6.69 | 11.45 ± 7.03 | 8.96 ± 4.80 | 0.098 |
Difference between the two CXR scores (initial minus post) | 1.36 ± 4.66 | 1.58 ± 4.59 | 0.48 ± 4.95 | 0.294 |
Duration of hospital stay (days) | 15.40 ± 10.38 | 15.67 ± 11.12 | 14.32 ± 6.78 | 0.563 |
Mortality * | ||||
Death at day 14 | 1 (0.8) | 1 (1.0) | 0 (0.0) | 1.000 |
Death at day 28 | 2 (1.6) | 2 (2.0) | 0 (0.0) | 1.000 |
Death at day 56 | 2 (1.6) | 2 (2.0) | 0 (0.0) | 1.000 |
All-cause mortality | 2 (1.6) | 2 (2.0) | 0 (0.0) | 1.000 |
Variables | Simple Linear Regression | Multiple Linear Regression | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
B | SE | β | t | p-Value | 95% CI for B | B | SE | β | t | p-Value | 95% CI for B | |||
Lower | Upper | Lower | Upper | |||||||||||
Regdanvimab use | 3.356 | 1.619 | 0.184 | 2.073 | 0.040 | 0.151 | 6.562 | 3.568 | 1.501 | 0.196 | 2.377 | 0.019 | 0.596 | 6.539 |
Age (per year) | −0.246 | 0.049 | −0.411 | −4.981 | <0.001 | −0.344 | −0.148 | −0.254 | 0.049 | −0.424 | −5.126 | <0.001 | −0.352 | −0.156 |
Female sex | 2.761 | 1.309 | 0.188 | 2.109 | 0.037 | 0.169 | 5.353 | 1.742 | 1.140 | 0.118 | 1.528 | 0.129 | −0.516 | 4.000 |
BMI (per kg/m2) | 0.306 | 0.193 | 0.142 | 1.585 | 0.116 | −0.076 | 0.689 | −0.043 | 0.181 | −0.020 | −0.238 | 0.812 | −0.402 | 0.316 |
Baseline SpO2/FiO2 ratio | 0.040 | 0.009 | 0.383 | 4.582 | <0.001 | 0.023 | 0.058 | 0.029 | 0.009 | 0.280 | 3.461 | 0.001 | 0.013 | 0.046 |
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Chae, G.; Choi, A.; Lim, S.; Park, S.; Lee, S.; Ahn, Y.; Kim, J.; Ra, S.; Jegal, Y.; Ahn, J.; et al. The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study. Trop. Med. Infect. Dis. 2022, 7, 51. https://doi.org/10.3390/tropicalmed7030051
Chae G, Choi A, Lim S, Park S, Lee S, Ahn Y, Kim J, Ra S, Jegal Y, Ahn J, et al. The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study. Tropical Medicine and Infectious Disease. 2022; 7(3):51. https://doi.org/10.3390/tropicalmed7030051
Chicago/Turabian StyleChae, Ganghee, Aram Choi, Soyeoun Lim, Sooneun Park, Seungjun Lee, Youngick Ahn, Jinhyoung Kim, Seungwon Ra, Yangjin Jegal, Jongjoon Ahn, and et al. 2022. "The Effectiveness of the Use of Regdanvimab (CT-P59) in Addition to Remdesivir in Patients with Severe COVID-19: A Single Center Retrospective Study" Tropical Medicine and Infectious Disease 7, no. 3: 51. https://doi.org/10.3390/tropicalmed7030051