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Clinical efficacy analysis of paxlovid in children with hematological diseases infected with the omicron SARS-CoV-2 new variant

Li et al., Frontiers in Pediatrics, doi:10.3389/fped.2023.1160929
Apr 2023  
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Resolution of fever -51% Improvement Relative Risk Time to viral- 58% Paxlovid for COVID-19  Li et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? Retrospective 20 patients in China (December 2022 - January 2023) Worse recovery (p=0.008) and faster viral clearance (p=0.033) c19early.org Li et al., Frontiers in Pediatrics, Apr 2023 Favorspaxlovid Favorscontrol 0 0.5 1 1.5 2+
Retrospective 20 pediatric hematological disease patients in China, showing faster viral clearance with paxlovid, but slower resolution of fever.
Resistance. Variants may be resistant to paxlovid1-3. Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID4.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid5. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid"6.
AKI. Kamo et al. show significantly increased risk of acute kidney injury.
resolution of fever, 51.3% higher, relative time 1.51, p = 0.008, treatment 9, control 11.
time to viral-, 57.6% lower, relative time 0.42, p = 0.03, treatment 9, control 11.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Li et al., 25 Apr 2023, retrospective, China, peer-reviewed, 9 authors, study period 10 December, 2022 - 20 January, 2023. Contact: chenchun@mail.sysu.edu.cn, xuehongman@sysush.com, chengyucai@sysush.com.
This PaperPaxlovidAll
Clinical efficacy analysis of paxlovid in children with hematological diseases infected with the omicron SARS-CoV-2 new variant
Yixian Li, Yong Liu, Luping Wen, Hui Chen, Wenqing Wang, Mengyao Tian, Yucai Cheng, Hongman Xue, Chun Chen
Frontiers in Pediatrics, doi:10.3389/fped.2023.1160929
Objective: To summarize the clinical characteristics of children with hematological malignancies co-infected with novel coronavirus and explore the safety and effectiveness of Paxlovid treatment. Methods: From December 10, 2022, to January 20, 2023, the clinical data of children with hematological diseases diagnosed with novel coronavirus infection in the outpatient and emergency department of the Seventh Affiliated Hospital of Sun Yat-sen University were retrospectively analyzed. Results: According to whether to give paxlovid or not, it is divided into group A (paxlovid group) and group B (non-paxlovid group). The length of fever was 1-6 days in group A and 0-3 days in group B. The viral clearance time was shorter in group A than in group B. The inflammatory indexes CRP and PCT were significantly higher in group A than in group B (P < 0.05). Twenty patients were followed up for 1 month after leaving the hospital, and there were 5 cases of reappearance of fever, 1 case of increased sleep, 1 case of physical fatigue and 1 case of loss of appetite within 2 weeks. Conclusions: Paxlovid has no apparent adverse reactions in children 12 years old and younger with underlying hematological diseases infected with the new coronavirus. Focusing on the interaction between paxlovid and other drugs is necessary during the treatment.
Ethics statement The studies involving human participants were reviewed and approved by Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin. Written informed consent was obtained from the individual(s), and minor(s)' legal guardian/next of kin, for the publication of any potentially identifiable images or data included in this article. Author contributions CC, HX and YC designed research; YL and YL analyzed data, and wrote the manuscript; LW, HC and WW acquired data, collected clinical data. MT reviewed the data. CC interpreted the data and reviewed the manuscript. All authors contributed to the article and approved the submitted version. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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'volume': '15', 'author': 'Badri', 'year': '2015', 'journal-title': 'Am J Transplant'}, { 'key': 'B35', 'doi-asserted-by': 'publisher', 'first-page': 'Cd007893', 'DOI': '10.1002/14651858.CD007893.pub2', 'article-title': 'Effect of cyclosporine on blood pressure', 'volume': '1', 'author': 'Robert', 'year': '2010', 'journal-title': 'Cochrane Database Syst Rev'}, { 'key': 'B36', 'doi-asserted-by': 'publisher', 'first-page': '191', 'DOI': '10.1097/FTD.0000000000001014', 'article-title': 'Therapeutic drug monitoring and dosage adjustments of immunosuppressive ' 'drugs when combined with nirmatrelvir/ritonavir in patients with ' 'COVID-19', 'volume': '45', 'author': 'Lemaitre', 'year': '2022', 'journal-title': 'Ther Drug Monit'}, { 'key': 'B37', 'doi-asserted-by': 'publisher', 'first-page': '939', 'DOI': '10.1002/lt.20165', 'article-title': 'Management of drug-to-drug interactions between cyclosporine A and the ' 'protease-inhibitor lopinavir/ritonavir in liver-transplanted ' 'HIV-infected patients', 'volume': '10', 'author': 'Vogel', 'year': '2004', 'journal-title': 'Liver Transpl'}], 'container-title': 'Frontiers in Pediatrics', 'original-title': [], 'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fped.2023.1160929/full', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 4, 25]], 'date-time': '2023-04-25T05:17:45Z', 'timestamp': 1682399865000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fped.2023.1160929/full'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 4, 25]]}, 'references-count': 37, 'alternative-id': ['10.3389/fped.2023.1160929'], 'URL': 'http://dx.doi.org/10.3389/fped.2023.1160929', 'relation': {}, 'ISSN': ['2296-2360'], 'subject': ['Pediatrics, Perinatology and Child Health'], 'container-title-short': 'Front. Pediatr.', 'published': {'date-parts': [[2023, 4, 25]]}}
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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