A new study from Mayo Clinic assessed the clinical outcomes of 1395 fully vaccinated adult patients ((mean age54.3 years; 60% female; median BMI 30.7) with breakthrough COVID-19 (developed PCR-confirmed breakthrough COVID-19 at least 2 weeks after the second of two69 doses of SARS-CoV-2 mRNA vaccine). The primary outcome was the rate of all-cause hospitalization by day 28, rates of severe disease measured by oxygen requirement, and the need for hospitalization. The degree of medical comorbidity was assessed using Monoclonal Antibody Screening Score(MASS), a clinical criterion for risk of severe outcomes. In the total population, the Delta variant was predominant, the majority were treated with casirivimab-imdevimab antibody cocktail, and the most common medical comorbidities were hypertension (34.5%), CVD (13.8%),116 chronic pulmonary diseases (13.6%), CKD (10.2%)and cancer (10.7%). Results showed that;
- Patients received monoclonal antibody treatment at a median of 5 days (interquartile range, 3-6 days) from symptom onset and 2 days (interquartile range, 1-3 days) from testing.
- The rate of hospitalization was 2.65% among patients treated with monoclonal antibodies compared to 10.7% among those who did not receive therapy (OR: 0.227; 95% CI, 0.128 - 0.403; p<0.001). Controlling for MASS, monoclonal antibody therapy was associated with a lower rate of hospitalization (OR: 0.14; 95% CI, 0.079-0.265; p<0.0001).
- The number needed to treat (NNT) to prevent one hospitalization:255 among vaccinated persons without high-risk medical comorbidity and between 3 and 8 among patients with multiple high-risk medical conditions.
- Sixty-one patients (4.4%) developed hypoxia and required oxygen supplementation, while monoclonal antibody treatment was significantly associated with lower rates of hypoxia (0.95% vs 6.45%; OR, 0.139; 95% CI, 0.055 –0.349; p <0.001).
- The majority (n=56; 91.8%) of patients who required oxygen supplementation did not receive monoclonal antibody treatment.
- Five (0.36%) patients required admission to the ICU, none of whom were treated with monoclonal antibodies.
- No death was reported among 1395 vaccinated patients with breakthrough COVID-19.
The study emphasizes and provides evidence on;
1. Need for other public health strategies (e.g., use of face mask and avoidance of large gatherings) for all individuals, even among vaccinated individuals, during periods characterized by high community SARS-CoV-2 Delta transmission.
2. The risk of hospitalization among breakthrough COVID-19 cases varies according to the degree of medical comorbidity.
3. The benefit of augmented passive immunotherapy among fully vaccinated patients with breakthrough COVID-19, especially evident among those with a high number of medical comorbidities.
Fully vaccinated persons, particularly those with multiple medical comorbidities, may develop breakthrough COVID-19. The severity of breakthrough COVID-19 significantly correlated with a high number of medical comorbidities. Early treatment with anti-spike monoclonal antibody was associated with a significantly lower rate of severe COVID-19 that would require hospitalization
For more details about the prescribing information, click here
Reference:
- Bierle DM, Ganesh R, Tulledge-Scheitel S, Hanson SN, Arndt LL, Wilker CG, Razonable RR. Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities. J Infect Dis. 2021 Nov 16:jiab570. doi: 10.1093/infdis/jiab570.
Disclaimer: This article has been published under MD Brand Connect Initiative.
Disclaimer: This content and information provided is intended for update strictlyforRegistered MedicalPractitioners/ Physicians treating Covid 19 only. The information mentioned herein is not intended nor implied to be a substitute for professional medical advice. Any advice regarding the management of any medical condition is totally in the discretion of doctor (Registered Medical Practitioner)/ physician treating Covid 19patients. Prescription of the drug is the prerogative of doctors (Registered Medical Practitioner/ Physician treating Covid 19) at his /her sole discretion. Physicians treating Covid 19 patients must refer to the full prescribing information of the product for use of product. Copying, reproduction, circulation of the information published here in any form or by any means either mechanically/ print or electronically without prior consent is strictly prohibited. Any unauthorised person having possession of this document should discard the same or inform/ notify/ return to Cipla Ltd. To report any adverse events/special situation with Cipla medicinal products email at drugsafety@cipla.com. or via the national Pharmacovigilance Programme of India by calling on 1800267 7779 (Cipla number) or you can report to PvPI on 1800 180 3024. By reporting side effects, you can help provide more information on the safetyofthis product. Forcomplete prescribing information, please login www.ciplamed.com
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.