Real-Life Experience of Molnupiravir in Hospitalized Patients Who Developed SARS-CoV2-Infection: Preliminary Results from CORACLE Registry
Abstract
:1. Introduction
2. Results
3. Discussion
4. Conclusions
5. Materials and Methods
Statistical Analysis
6. Patents
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Main Characteristics of Hospitalized Patients Treated with Molnupiravir n = 44 (100%) | |
---|---|
Age (median, years) | 79 (IQR range, 51–93)
|
Sex | Male 27 (57.4) |
Past Smoker | 4 (8.5) |
BMI | 21.5 (IQR range, 18.7–30.1) |
Scores | |
CCI | 5 (IQR range, 3–10) |
4C | 9.9 (IQR range, 4–12) |
Comorbidities | |
Cardiovascular diseases | 32 (68.1) |
CKD | 14 (29.8) |
Pulmonary diseases | 12 (25.5) |
Neurologic diseases | 10 (21.3) |
Solid tumor | 9 (19.1) |
Haematological diseases | 5 (10.6) |
Diabetes | 15 (31.9) |
SOT | 1 (2.1) |
Rheumatologic diseases | 2 (4.5) |
Reason of Admission in Hospital | |
Heart failure | 9 (20.4) |
Liver failure | 4 (8.5) |
Anemia | 3 (6.8) |
Femoral neck fracture | 3 (6.4) |
CAP | 2 (4.3) |
Gastrointestinal Diseases | 3 (6.4) |
Neurological Diseases | 2 (4.5) |
Cancer | 2 (4.5) |
UTI | 3 (6.4) |
Previous COVID-19 or SARS-CoV-2 Vaccination | |
Previous COVID-19 | 3 (6.4%) |
V0 | 5 (10.6) |
V1 | 0 |
V2 | 8 (17) |
V3 | 31 (66) |
First doses | 39 (30 BioNTech/Pfizer; 8 Moderna; 1 Johnson and Johnson) |
Second doses | 39 (31 BioNTech/Pfizer; 8 Moderna) |
Third Doses | 31 (24 BioNTech/Pfizer; 7 Moderna) |
Previous Oxygen for Chronic O2-therapynd Start Oxygen after SARS-CoV- | |
Patients in O2-therapy before molnupiravir | 8 (18.1) |
Start O2 during molnupiravir or increase | 8 (18.1) |
Hospital acquired infections | |
Nosocomial superinfections | 5 (10.5) |
UTI | 4 (Escherichia coli ESBL, Proteus mirabilis, Enterococcus faecium Vancomycin-resistant; Klebsiella oxytoca) |
BSI | 1 (Enterococcus faecium Vancomycin-resistant) |
Events during molnupiravir Treatment | |
Adverse events during Molnupiravir | 0 (0) |
Pill missed | 0 (0) |
Outcomes | |
Survival | 39 (88.6) |
Time to positivity and SARS-CoV-2 positivity | |
Time from last vaccination to SARS-CoV-2 positivity | 96.8 (7–240) days |
Time from admission to SARS-CoV-2 S/S start | 15 (5–33) days |
Laboratory Value | T0 | T5 | Wilcoxon Test * |
---|---|---|---|
AST (UI/L) | 49.88 (9–296) | 41.3 (15–157) | 0.737 |
ALT (UI/L) | 36.12 (3–254) | 29.02 (9–110) | 0.522 |
Creatinine (mg/dL) | 1.05 (0.38–2.5) | 0.97 (0.39–1.9) | 0.128 |
WBC (total count) | 6676 (2500–18,930) | 9201 (3120–65,330) | 0.501 |
Lymphocyte (absolute count) | 1149 (340–2450) | 3500 (510–57,490) | 0.081 |
Monocyte (absolute count) | 639 (270–1410) | 546.67 (230–580) | 0.048 |
Eosinophile (absolute count) | 150(0–560) | 127(0–810) | 0.394 |
PLTS (absolute count) | 189(0.112–400) | 221 (0.243–479) | 0.162 |
Variable | Survived n = 39 (88.6%) | Dead n = 5 (11.4%) | Total n = 44 (100%) | p-Value |
---|---|---|---|---|
Basal characteristics | ||||
Gender (Males) | 16 (36.4%) | 1 (2.3%) | 17 (38.6%) | 0.36 |
Age | 76 ± 13 (SD) | 68 ± 8 (SD) | 79 ± 13 (SD) | 0.06 |
Clinical characteristics | ||||
Cardiovascular disease/hypertension | 29 (65.9%) | 3 (6.8%) | 32 (72.7%) | 0.49 |
Pulmonary disease | 9 (20.5%) | 3 (6.8%) | 12 (27.3%) | 0.08 |
4C score | 9.8 ± 2.03 (SD) | 11 ± 1.4 (SD) | 10 ± 2 (SD) | 0.43 |
CCI | 5.9 ± 1.8 (SD) | 5.5 ± 1.8 (SD) | 6 ± 2 (SD) | 0.57 |
Vaccination | ||||
Not vaccinated | 4 (9.1%) | 1 (2.3%) | 5 (11.4%) | 0.51 |
Vaccinated (Second dose) | 8 (18.2%) | 0 | 8 (18.2%) | 0.26 |
Vaccinated (Third dose) | 27 (61.4%) | 4 (9.1%) | 31 (70.5%) | 0.61 |
Variable | No Oxygenation n = 36 (81.8%) | Oxygenation n = 8 (18.1%) | Total n = 44 (100%) | p-Value |
---|---|---|---|---|
Basal characteristics | ||||
Gender (Males) | 14 (31.8%) | 3 (6.8%) | 17 (38.6%) | 0.94 |
Age | 75 ± 12.5 (SD) | 79 ± 11 (SD) | 76 ± 13 (SD) | 0.36 |
Past smoker | 2 (4.5%) | 2 (4.5%) | 4 (9.1%) | 0.08 |
Clinical characteristics | ||||
Cardiovascular disease/hypertension | 28 (63.6%) | 4 (9.1%) | 32 (72.7%) | 0.11 |
Kidney disease | 12 (27.3%) | 2 (4.5%) | 14 (31.8%) | 0.64 |
Pulmonary disease | 10 (22.7%) | 2 (4.5%) | 12 (27.3%) | 0.87 |
Neurologic disease | 8 (18.2%) | 2 (4.5%) | 10 (22.7%) | 0.86 |
Oncologic disease | 6 (13.6%) | 3 (6.8%) | 9 (20.5%) | 0.18 |
Hematological disease | 5 (11.4%) | 0 | 5 (11.4%) | 0.26 |
Diabetes | 13 (29.5%) | 2 (4.5%) | 15 (34.1%) | 0.54 |
Nosocomial infection | 4 (9.1%) | 1 (2.3%) | 5 (11.4%) | 0.74 |
4C score | 9.8 ± 2 (SD) | 10 ± 2 (SD) | 10 ± 2 (SD) | 0.55 |
CCI | 6 ± 1.9 (SD) | 6 ± 1.9 (SD) | 6 ± 2 (SD) | 0.35 |
Vaccination | ||||
Not vaccinated | 3 (6.8%) | 2 (4.5%) | 5 (11.4%) | 0.17 |
Vaccinated (Second dose) | 7 (21.9%) | 1 (3.1%) | 8 (25%) | 0.77 |
Vaccinated (Third dose) | 26 (59.1%) | 5 (11.4%) | 31 (70.5%) | 0.58 |
Age/Sex | CCI | 4C | Hospital Admission | Other Comorbidities | Vaccination Status | Start O2 | Superinfections | COVID-19 Related Death |
---|---|---|---|---|---|---|---|---|
63/F | 7 | 7 | Chronic hepatic failure with increasing ascitis | COPD, CNS | Three doses | No | No | No |
60/M | 8 | 7 | Urinary Obstruction and urinary tract stenting | CV, COPD, Malignancy, DM | Three doses | Yes, NC | Yes, septic shock | No |
59/F | 8 | 9 | Chronic kidney failure in hemodyalisis with refractory hyperkalemia | CV, COPD, DM | Three doses | No | No | No |
74/F | 11 | 10 | Atrial fibrillation and myocardial injury | CV, CKD, DM | Unvaccinated | Yes, NC | No | No |
82/F | 12 | 11 | Pace-maker device infection | CV, CKD, COPD, DM | Three doses | No | No | No |
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Lupia, T.; Corcione, S.; Shbaklo, N.; Boglione, L.; Torresan, S.; Pinna, S.M.; Rizzello, B.; Bosio, R.; Fornari, V.; Brusa, M.T.; et al. Real-Life Experience of Molnupiravir in Hospitalized Patients Who Developed SARS-CoV2-Infection: Preliminary Results from CORACLE Registry. Antibiotics 2022, 11, 1541. https://doi.org/10.3390/antibiotics11111541
Lupia T, Corcione S, Shbaklo N, Boglione L, Torresan S, Pinna SM, Rizzello B, Bosio R, Fornari V, Brusa MT, et al. Real-Life Experience of Molnupiravir in Hospitalized Patients Who Developed SARS-CoV2-Infection: Preliminary Results from CORACLE Registry. Antibiotics. 2022; 11(11):1541. https://doi.org/10.3390/antibiotics11111541
Chicago/Turabian StyleLupia, Tommaso, Silvia Corcione, Nour Shbaklo, Lucio Boglione, Stefano Torresan, Simone Mornese Pinna, Barbara Rizzello, Roberta Bosio, Valentina Fornari, Maria Teresa Brusa, and et al. 2022. "Real-Life Experience of Molnupiravir in Hospitalized Patients Who Developed SARS-CoV2-Infection: Preliminary Results from CORACLE Registry" Antibiotics 11, no. 11: 1541. https://doi.org/10.3390/antibiotics11111541