Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jul 2;25(1):493.
doi: 10.1186/s12887-025-05807-1.

Paxlovid for the treatment of severe or critical COVID-19 in children

Linjuan Xiang #  1   2 , Qun Wang #  1   2 , Yanwen Xu #  1   2 , Yu Tong  1 , Yuhang Wu  1 , Xiaoshan Zhang  3 , Xinxin Zeng  1 , Sheng Ye  4 , Chenmei Zhang  4 , Linhua Tan  5 , Lvchang Zhu  4 , Jing Miao  6 , Sun Chen  7 , Xi Zhang  8 , Xuben Yu  9 , Lisu Huang  10
Affiliations

Paxlovid for the treatment of severe or critical COVID-19 in children

Linjuan Xiang et al. BMC Pediatr. .

Abstract

Background: Paxlovid, known for its efficacy against SARS-CoV-2, is currently limited in its use for treating pediatric COVID-19, particularly in severe or critical cases.

Methods: We conducted a study within a single-center, prospective cohort of 450 children diagnosed with COVID-19 between December 2022 and May 2023. This study included 30 pediatric patients who received Paxlovid and 60 matched controls who did not, based on factors such as age, disease severity, and underlying health conditions. Safety was assessed through the incidence of adverse events, and laboratory parameters. The time to clinical symptom improvement was the main efficacy outcome. Moreover, we calculated the AUC0 - 12 h of Nirmatrelvir of the Paxlovid patients.

Results: Adverse events occurred in 16.7% of both groups, with no serious events reported. The Paxlovid group showed a significantly shorter time to viral clearance, fever resolution, and symptom recovery compared to controls (4.9 vs. 11.0 days, P = 0.01; 11.2 vs. 16.4 days, P = 0.01; 4.6 vs. 17.6 days, P < 0.01). This effect was most noticeable in children with underlying conditions or those treated early. No significant differences were observed in ICU transfers or mortality (P > 0.05). The AUC₀-₁₂h of Nirmatrelvir did not significantly alter treatment outcomes.

Conclusion: Our findings suggest that Paxlovid may be a safe and effective option for treating severe or critical COVID-19 in children.

Keywords: COVID-19; Children; Critical; Paxlovid; Pharmacokinetics.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was approved by the Ethics Committee of the Children’s Hospital of Zhejiang University School of Medicine (IRB No. 2023-IRB-0176-P-01). Informed consent was obtained from the legal guardians of all children in two groups. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
Kaplan–Meier Analysis of the Effects of Paxlovid Treatment. Efficacy outcome of (A) the time to negative conversion after treatment, (B) fever duration after treatment, and (C) symptom recovery time after treatment
Fig. 3
Fig. 3
Efficacy Assessment of Paxlovid and Matched Control Groups, Stratified by Clinical Type and Timing of Medication Initiation. Efficacy outcomes of patients (A) with severe COVID-19, (B) with critical COVID-19, (C) who take medicine within five days from onset of symptoms and (D) who take medicine beyond five days from onset of symptoms. *P < 0.05, **P < 0.01
See this image and copyright information in PMC

References

    1. WHO COVID-19 Dashboard. Geneva: World Health Organization. 2023 [Available from: https://covid19.who.int/October2023
    1. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for High-Risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386(15):1397–408. 10.1056/NEJMoa2118542. - PMC - PubMed
    1. Huang J, Yin D, Qin X, et al. Case report: application of nirmatrelvir/ritonavir to treat COVID-19 in a severe aplastic anemia child after allogeneic hematopoietic stem cell transplantation. Front Pead. 2022;10:935118. 10.3389/fped.2022.935118. - PMC - PubMed
    1. Vora SB, Englund JA, Trehan I, et al. Monoclonal antibody and antiviral therapy for Mild-to-Moderate COVID-19 in pediatric patients. Pediatr Infect Dis J. 2023;42(1):32–4. 10.1097/inf.0000000000003740. [published Online First: 2022/12/09]. - PMC - PubMed
    1. Young C, Papiro T, Greenberg JH. Elevated tacrolimus levels after treatment with nirmatrelvir/ritonavir (Paxlovid) for COVID-19 infection in a child with a kidney transplant. Pediatr Nephrol. 2023;38(4):1387–88. 10.1007/s00467-022-05712-0. [published Online First: 2022/08/19]. - PMC - PubMed

Substances

LinkOut - more resources