Molnupiravir Outpatient Treatment for Adults with COVID-19 in a Real-World Setting—A Single Center Experience
Abstract
1. Introduction
Background
2. Materials and Methods
2.1. Study Population and Design
2.2. Statistical Analysis
2.3. Aim and Study Endpoints
3. Results
3.1. Relationship between the Pre-Defined Risk Factors and Severe COVID-19 Course
3.2. Analysis of Subpopulations
3.3. Safety Profile
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 | Value [N = 107] |
---|---|
Age * | |
mean | 53.7 (18.1) years |
range | 24–95 years |
Male sex | 65 (60.75%) |
Risk factors for severe COVID-19 | |
Immunosuppression | 72 (67.3%) |
Transplantation | 71 (66.4%) |
Type of transplanted organ | |
kidney | 51 (71.8%) |
liver | 13 (18.3%) |
Other ** | 7 (9.6%) |
Time after transplant * | 6.6 (7.0) years |
Age > 65 years | 28 (26.2%) |
Diabetes mellitus | 34 (31.8%) |
Obesity | 1 (0.9%) |
Chronic obstructive pulmonary disease | 3 (2.8%) |
Chronic kidney disease | 49 (42.8%) |
stage 2 | 11 (22.5%) |
stage3 | 19 (38.8%) |
stage 4 | 5 (10.2%) |
stage 5 | 14 (28.6%) |
Heart failure | 16 (14.9%) |
Ischemic heart disease | 24 (22.5%) |
Cardiomyopathy | - |
Nursing home resident | - |
Active cancer | 9 (8.4%) |
Subjects with two risk factors for severe COVID-19 | 47 (43.9%) |
Subjects with three risk factors for severe COVID-19 | 28 (26.1%) |
Subjects with four risk factors for severe COVID-19 | 20 (18.7%) |
Subject with more than four risk factors for severe COVID-19 | 9 (8.4%) |
SARS-CoV-2 infection confirmation | |
RT-PCR test | 92 (86.0%) |
Antigen test | 15 (14.0%) |
Confirmed previous history of COVID-19 | 12 (11.2%) |
Vaccination status | |
Full course of vaccination completed | 83 (77.6%) |
Received booster dose | 56 (67.5%) |
Clinical Symptoms | Frequency (%) | |
---|---|---|
Yes | No | |
Cough | 58 (54.2%) | 49 (45.8%) |
Fever | 56 (52.4%) | 51 (47.6%) |
Sore throat | 36 (33.7%) | 71 (66.3%) |
Myalgia | 19 (17.8%) | 88 (82.2%) |
Headache | 15 (14%) | 92 (86%) |
Subfebrile state | 15 (14%) | 92 (86%) |
Weakness | 15 (14%) | 92 (86%) |
Diarrhea | 10 (9.3%) | 97 (90.6%) |
Nausea | 8 (7.5%) | 99 (92.5%) |
Lack of appetite | 8 (7.5%) | 99 (92.5%) |
Fatigue | 7 (6.5%) | 100 (93.5%) |
Vomiting | 6 (5.6%) | 101 (94.4%) |
Dyspnea | 5 (4.6%) | 102 (95.3%) |
Runny nose | 5 (4.7%) | 102 (95.3%) |
Sinusitis | 5 (5.6%) | 101 (94.4%) |
Nasal congestion | 4 (3.7%) | 103 (96.2%) |
Other | 14 (13.1%) | 93 (86.9%) |
Risk Factors | Risk of Hospitalization and Death | ||
---|---|---|---|
df | V | pFisher | |
Transplantation | 1 | 0.11 | 0.256 |
Immunosuppression | 2 | 0.12 | 0.339 |
Age > 65 years | 1 | 0.31 | 0.003 |
Diabetes mellitus | 1 | 0.07 | 0.552 |
Obesity | 1 | 0.04 | 1.000 |
Chronic obstructive pulmonary disease | 1 | 0.07 | 1.000 |
Chronic kidney disease | 1 | 0.07 | 1.000 |
Heart failure | 1 | 0.36 | 0.001 |
Ischemic heart disease | 1 | 0.30 | 0.005 |
Cardiomyopathy | no cases with cardiomyopathy met | ||
Nursing home resident | no cases with nursing home resident met | ||
Active cancer | 1 | 0.17 | 0.112 |
Risk Factors | Risk of Hospitalization and Death | |||
---|---|---|---|---|
n | df | φc | pFisher | |
Previous COVID-19 infection | 107 | 1 | 0.03 | 0.675 |
Full course of vaccination | 107 | 1 | 0.02 | 1.000 |
Booster dose | 83 | 1 | 0.14 | 0.320 |
Risk Factors | Group | Adverse Events of Molnupiravir Treatment, % | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dizziness | Diarrhea | Vomiting | Urticaria | Headache | Nausea | Rash | Weakness | Abdominal Pain | Herpes Zoster | Deterioration of Blood Pressure Control | ||||||||||
Transplantation | No | 1.9 | 0 | 0 | 0.9 | 0.9 | 2.8 | 0 | 2.8 | 1.9 | 0 | 0.9 | ||||||||
Yes | 2.8 | 0.9 | 0.9 | 0 | 1.9 | 4.7 | 0.9 | 11.2 | 2.8 | 0.9 | 0 | |||||||||
Immunosuppression | No | 1.9 | 0 | 0 | 0.9 | 0 | 2.8 | 0 | 2.8 | 1.9 | 0 | 0 | ||||||||
Yes | 1.9 | 0.9 | 0.9 | 0 | 2.8 | 4.7 | 0.9 | 11.2 | 2.8 | 0.9 | 0.9 | |||||||||
Age > 65 | No | 0.9 | 0.9 | 0.9 | 0.9 | 1.9 | 3.7 | 0.9 | 9.3 | 3.7 | 0.9 | 0.9 | ||||||||
Yes | 3.7 | 0 | 0.9 | 0 | 0.9 | 3.7 | 0 | 4.7 | 0.9 | 0 | 0 | |||||||||
Diabetes mellitus | No | 0.9 | 0.9 | 1.9 | 0.9 | 1.9 | 2.8 | 0.9 | 9.3 | 3.7 | 0 | 0.9 | ||||||||
Yes | 3.7 | 0 | 0 | 0 | 0.9 | 4.7 | 0 | 4.7 | 0.9 | 0.9 | 0 | |||||||||
Obesity | No | 4.7 | 0.9 | 1.9 | 0.9 | 2.8 | 6.5 | 0.9 | 14.0 | 4.7 | 0.9 | 0.9 | ||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0.9 | 0 | 0 | 0 | 0 | 0 | |||||||||
Chronic obstructive pulmonary disease | No | 4.7 | 0.9 | 1.9 | 0.9 | 2.8 | 7.5 | 0.9 | 14.0 | 4.7 | 0.9 | 0.9 | ||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||
Chronic kidney disease | No | 1.9 | 0.9 | 0.9 | 0 | 1.9 | 2.8 | 0.9 | 9.3 | 2.8 | 0 | 0 | ||||||||
Yes | 2.8 | 0 | 0.9 | 0.9 | 0.9 | 4.7 | 0 | 4.7 | 1.9 | 0.9 | 0.9 | |||||||||
Heart failure | No | 4.7 | 0.9 | 1.9 | 0.9 | 2.8 | 7.5 | 0.9 | 10.3 | 3.7 | 0.9 | 0.9 | ||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3.7 | 0.9 | 0 | 0 | |||||||||
Ischemic heart disease | No | 2.8 | 0.9 | 1.9 | 0.9 | 2.8 | 6.5 | 0.9 | 11.2 | 3.7 | 0.9 | 0.9 | ||||||||
Yes | 1.9 | 0 | 0 | 0 | 0 | 0.9 | 0 | 2.8 | 0.9 | 0 | 0 | |||||||||
Cardiomyopathy | No cases with cardiomyopathy explored | |||||||||||||||||||
Nursing home resident | No cases with nursing home residents explored | |||||||||||||||||||
Active cancer | No | 4.7 | 0.9 | 1.9 | 0.9 | 2.8 | 6.5 | 0 | 12.1 | 3.7 | 0.9 | 0.9 | ||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0.9 | 0.9 | 1.9 | 0.9 | 0 | 0 | |||||||||
Risk factors | Group | Adverse events of molnupiravir treatment (continued) | ||||||||||||||||||
Appetite increase | Pneumonia | Catheter-related sepsis | Appetite worsening | Worsening of diabetes control | Pruritus | Hypotension requiring hospitalization | Other | |||||||||||||
Transplantation | No | 0 | 0 | 0.9 | 0 | 0.9 | 0.9 | 0.9 | 0.9 | |||||||||||
Yes | 1.9 | 0.9 | 0 | 0.9 | 0 | 0 | 0 | 0 | ||||||||||||
Immunosuppression | No | 0 | 0 | 0.9 | 0 | 0.9 | 0.9 | 0.9 | 0.9 | |||||||||||
Yes | 1.9 | 0.9 | 0 | 0.9 | 0 | 0 | 0 | 0 | ||||||||||||
Age > 65 years | No | 1.9 | 0.9 | 0 | 0.9 | 0 | 0.9 | 0.9 | 0 | |||||||||||
Yes | 0 | 0 | 0.9 | 0 | 0.9 | 0 | 0 | 0.9 | ||||||||||||
Diabetes mellitus | No | 0.9 | 0.9 | 0.9 | 0.9 | 0 | 0 | 0.9 | 0 | |||||||||||
Yes | 0.9 | 0 | 0 | 0 | 0.9 | 0.9 | 0 | 0.9 | ||||||||||||
Obesity | No | 1.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | |||||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||
Chronic obstructive pulmonary disease | No | 1.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0 | 0.9 | |||||||||||
Yes | 0 | 0 | 0.9 | 0 | 0 | 0 | 0.9 | 0 | ||||||||||||
Chronic kidney disease | No | 1.9 | 0.9 | 0 | 0.9 | 0 | 0 | 0 | 0 | |||||||||||
Yes | 0 | 0 | 1.8 | 0 | 0.9 | 0.9 | 0.9 | 0.9 | ||||||||||||
Heart failure | No | 1.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0 | |||||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.9 | ||||||||||||
Ischemic heart disease | No | 1.9 | 0.9 | 0.9 | 0.9 | 0.9 | 0 | 0.9 | 0 | |||||||||||
Yes | 0 | 0 | 0 | 0 | 0 | 0.9 | 0 | 0.9 | ||||||||||||
Cardiomyopathy | No cases with cardiomyopathy explored | |||||||||||||||||||
Nursing home resident | No cases with nursing home residents explored | |||||||||||||||||||
Active cancer | No | 1.9 | 0.9 | 0.9 | 0.9 | 0 | 0.9 | 0.9 | 0.9 | |||||||||||
Yes | 0 | 0 | 0 | 0 | 0.9 | 0 | 0 | 0 |
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Czarnecka, K.; Czarnecka, P.; Tronina, O.; Durlik, M. Molnupiravir Outpatient Treatment for Adults with COVID-19 in a Real-World Setting—A Single Center Experience. J. Clin. Med. 2022, 11, 6464. https://doi.org/10.3390/jcm11216464
Czarnecka K, Czarnecka P, Tronina O, Durlik M. Molnupiravir Outpatient Treatment for Adults with COVID-19 in a Real-World Setting—A Single Center Experience. Journal of Clinical Medicine. 2022; 11(21):6464. https://doi.org/10.3390/jcm11216464
Chicago/Turabian StyleCzarnecka, Kinga, Paulina Czarnecka, Olga Tronina, and Magdalena Durlik. 2022. "Molnupiravir Outpatient Treatment for Adults with COVID-19 in a Real-World Setting—A Single Center Experience" Journal of Clinical Medicine 11, no. 21: 6464. https://doi.org/10.3390/jcm11216464
APA StyleCzarnecka, K., Czarnecka, P., Tronina, O., & Durlik, M. (2022). Molnupiravir Outpatient Treatment for Adults with COVID-19 in a Real-World Setting—A Single Center Experience. Journal of Clinical Medicine, 11(21), 6464. https://doi.org/10.3390/jcm11216464