Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Molnupiravir—Data on Use in Our Clinical Practice
3.2. Comparison of Real-World Data with Clinical Trial Data
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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Characteristics | Number | Percentage (%) |
---|---|---|
Demographic data | ||
Male sex | 26 | 56.5 |
Female sex | 20 | 43.5 |
Median age (years) | 48.5 (IQR: 37.8, 67.0) | |
Chronic condition | ||
Obesity | 14 | 30.4 |
Cardiovascular disease | 13 | 28.3 |
Asthma | 2 | 4.3 |
COPD | 1 | 2.2 |
Neoplasia | 5 | 10.9 |
Chronic kidney disease | 0 | 0.0 |
Autoimmune disease | 1 | 2.2 |
Diabetes mellitus | 7 | 15.2 |
Other | 3 | 6.5 |
1 chronic condition | 15 | 60.0 * |
2 chronic conditions | 7 | 28.0 * |
3 chronic conditions | 3 | 12.0 * |
COVID-19 vaccination status | ||
2 doses mRNA vaccine | 11 | 29.0 |
3 doses mRNA vaccine | 25 | 65.8 |
1 dose viral vector vaccine ** | 1 | 2.6 |
2 doses viral vector vaccine | 1 | 2.6 |
Symptoms | Male (N = 26) | Female (N = 20) | p-Value | Vaccinated (N = 36) | Unvaccinated (N = 8) | p-Value | Total (N = 46) |
---|---|---|---|---|---|---|---|
Cough | 15 (57.7) | 17 (85.0) | 0.046 | 25 (65.8) | 7 (87.5) | 0.225 | 32 (69.6) |
Headache | 10 (38.5) | 14 (70.0) | 0.034 | 19 (52.8) | 5 (62.5) | 0.520 | 24 (52.2) |
Sore throat | 13 (50.0) | 12 (60.0) | 0.500 | 23 (63.9) | 2 (25.0) | 0.067 | 25 (54.3) |
Myalgia | 9 (34.6) | 8 (40.0) | 0.708 | 11 (30.1) | 6 (75.0) | 0.019 | 17 (37.0) |
Fever | 9 (34.6) | 8 (40.0) | 0.708 | 13 (34.2) | 4 (50.0) | 0.400 | 17 (37.0) |
Rhinorrhea | 8 (30.8) | 9 (45.0) | 0.322 | 13 (34.2) | 4 (50.0) | 0.400 | 17 (37.0) |
Malaise | 5 (19.2) | 5 (25.0) | 0.638 | 6 (15.8) | 4 (50.0) | 0.033 | 10 (21.7) |
Chest pain | 2 (7.7) | 1 (5.0) | NA | 1 (2.8) | 2 (25.0) | NA | 3 (6.5) |
Diarrhea | 2 (7.7) | 0 (0.0) | NA | 0 (0.0) | 2 (25.0) | NA | 2 (4.3) |
Laboratory Parameters | Results | Normal Range | |
---|---|---|---|
Leukocyte count, mean (±SD) | 5824 (±2428) cells/μL | 3600–9600 cells/μL | |
Leukocytes increase, n (%) | 4 (8.7) | ||
Neutrophil count, mean (±SD) | 3840 (±1973) cells/μL | 1400–6500 cells/μL | |
Neutrophils increase, n (%) | 1 (2.2) | ||
Lymphocyte count, median (IQR) | 1265 (855, 1757) cells/μL | 1200–3400 cells/μL | |
Lymphocytes decrease, n (%) | 17 (37.0) | ||
Hemoglobin, mean (±SD) | 13.6 (±1.3) g/dL | 12.1–17.2 g/dL | |
Anemia, n (%) | 2 (4.3) | ||
C-reactive protein, mean (±SD) | 14.1 (±3.8) mg/L | 0–3.00 mg/L | |
Inflammatory syndrome, n (%) | 26 (60.5) | ||
AST, mean (±SD) | 35.5 (±21.5) U/L | 14–36 U/L | |
TGP increase, n (%) | 12 (26.1) | ||
ALT, mean (±SD) | 34.3 (±14.9) U/L | 4–35 U/L | |
TGO increase, n (%) | 11 (23.9) | ||
LDH, median (IQR) | 197 (167, 209) U/L | 120–246 U/L | |
LDH increase, n (%) | 2 (4.3) | ||
CK¸ mean (±SD) | 69.5 (±19.5) U/L | 55–170 U/L | |
CK increase, n (%) | 3 (6.5) | ||
Urea, median (IQR) | 31.5 (20.5, 35.0) mg/dL | 19.26–42.8 mg/dL | |
Urea increase, n (%) | 12 (26.1) | ||
Creatinine, mean (±SD) | 0.6 (±0.2) mg/dL | 0.66–1.25 mg/dL | |
Creatinine increase, n (%) | 3 (6.5) | ||
Glucose, mean (±SD) | 105 (±14) mg/dL | 74–106 mg/dL | |
Glucose increase, n (%) | 16 (34.8) |
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Streinu-Cercel, A.; Miron, V.D.; Oană, A.A.; Irimia, M.; Popescu, R.Ș.; Dărămuș, I.A.; Moțoi, M.M.; Ceapraga, G.J.; Săndulescu, O. Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center. Pharmaceuticals 2022, 15, 1065. https://doi.org/10.3390/ph15091065
Streinu-Cercel A, Miron VD, Oană AA, Irimia M, Popescu RȘ, Dărămuș IA, Moțoi MM, Ceapraga GJ, Săndulescu O. Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center. Pharmaceuticals. 2022; 15(9):1065. https://doi.org/10.3390/ph15091065
Chicago/Turabian StyleStreinu-Cercel, Anca, Victor Daniel Miron, Alina Alexandra Oană, Mădălina Irimia, Ramona Ștefania Popescu, Ioana Andreea Dărămuș, Maria Magdalena Moțoi, Gabriela Jana Ceapraga, and Oana Săndulescu. 2022. "Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center" Pharmaceuticals 15, no. 9: 1065. https://doi.org/10.3390/ph15091065
APA StyleStreinu-Cercel, A., Miron, V. D., Oană, A. A., Irimia, M., Popescu, R. Ș., Dărămuș, I. A., Moțoi, M. M., Ceapraga, G. J., & Săndulescu, O. (2022). Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center. Pharmaceuticals, 15(9), 1065. https://doi.org/10.3390/ph15091065