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Remdesivir for Children with COVID-19

Is remdesivir effective?

  • Ambulatory Setting: For children in the ambulatory setting, evidence is extrapolated from adult studies in which treatment may reduce the rate of hospitalization.
  • Inpatient Setting:
As a whole, studies of hospitalized children are inconclusive because treatment arms differed significantly by disease severity, comorbidities, number of days of remdesivir treatment, and other treatments given.

Is remdesivir safe?

  • Elevations in AST, ALT, and creatinine have been reported in patients with varying comorbidities and severity of COVID-19 illness. Most lab abnormalities were transient. Some comorbidities and COVID-19 disease itself can cause such laboratory abnormalities. Without matched controls, the abnormalities cannot be clearly attributed to remdesivir.


To determine the value of daily intravenous remdesivir for a specific patient, the COVID-19 Clinical Pathway Committee recommends shared decision-making with consideration of feasibility, patient comfort, cost (including non-monetary), and values of the patient/family.

For a comprehensive summary, refer to COVID-19 in Children - Evidence for Treatment with Remdesivir.

References:

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Bhimraj, A., Morgan, R.L., Hirsch Shumaker, A., Baden, L.R., Chi-Chung Cheng, V., Edwards, K.M., Gallagher, J.C., Gandhi, R.T., Muller, W.J., Nakamura, M.M. O’Horo, J.C., Shafer, R.W., Shoham, S., Murad, M.H., Mustafa, R. A., Sultan, S., & Falck-Ytter, Y. (2024, June). Infectious Diseases Society of America: Guidelines on the treatment and management of patients with COVID-19, Clinical Infectious Diseases, 78(7), e250-e349. https://doi.org/10.1093/cid/ciac724

Goldman, J. D., Lye, D. C. B., Hui, D. S., Marks, K. M., Bruno, R., Montejano, R., Spinner, C. D., Galli, M., Ahn, M. Y., Nahass, R. G., Chen, Y. S., SenGupta, D., Hyland, R. H., Osinusi, A. O., Cao, H., Blair, C., Wei, X., Gaggar, A., Brainard, D. M., Towner, W. J., … GS-US-540-5773 Investigators (2020). Remdesivir for 5 or 10 days in patients with severe COVID-19. The New England journal of medicine, 383(19), 1827–1837. https://doi.org/10.1056/NEJMoa2015301

Goldman, D. L., Aldrich, M. L., Hagmann, S. H. F., Bamford, A., Camacho-Gonzalez, A., Lapadula, G., Lee, P., Bonfanti, P., Carter, C. C., Zhao, Y., Telep, L., Pikora, C., Naik, S., Marshall, N., Katsarolis, I., Das, M., DeZure, A., Desai, P., Cao, H., Chokkalingam, A. P., … Méndez-Echevarría, A. (2021). Compassionate use of remdesivir in children with severe COVID-19. Pediatrics, 147(5), e2020047803. https://doi.org/10.1542/peds.2020-047803

Gottlieb, R. L., Vaca, C. E., Paredes, R., Mera, J., Webb, B. J., Perez, G., Oguchi, G., Ryan, P., Nielsen, B. U., Brown, M., Hidalgo, A., Sachdeva, Y., Mittal, S., Osiyemi, O., Skarbinski, J., Juneja, K., Hyland, R. H., Osinusi, A., Chen, S., Camus, G., … GS-US-540-9012 (PINETREE) Investigators (2022). Early remdesivir to prevent progression to severe Covid-19 in outpatients. The New England journal of medicine, 386(4), 305–315. https://doi.org/10.1056/NEJMoa2116846

Jinda, T., Mizuno, S., Tatami, S., Kasai, M., & Ishida, T. (2024). Risk factors for liver enzyme elevation with remdesivir use in the treatment of paediatric COVID-19. J Paediatr Child Health, 60(7), 299–302. doi:10.1111/jpc.16569 Kautsch, K., Wiśniowska, J., Friedman-Gruszczyńska, J., & Buda, P. (2024). Evaluation of the safety profile and therapeutic efficacy of remdesivir in children with SARS-CoV-2 infection - a single-center, retrospective, cohort study. Eur J Pediatr, 183(2), 591-598. doi:10.1007/s00431-023-05287-4

Manabe, S., Mizuno, S., Jinda, T., & Kasai, M. (2022). Safety of remdesivir in 20 children with COVID-19-case series-Biological & Pharmaceutical Bulletin, 45(12), 1853–1856. https://doi.org/10.1248/bpb.b22-00470

Minotti, C., Mengato, D., De Pieri, M., Trivellato, S., Francavilla, A., Di Chiara, C., Liberati, C., Mattera, R., Biffi, A., Giaquinto, C., Venturini, F., & Donà, D. (2023). Early treatments of fragile children with COVID-19: Results of CLEVER (Children COVID Early Treatment), a retrospective, observational study. Viruses, 15(1), 192. https://doi.org/10.3390/v15010192

Player, b., Huppler, A.R., Pan, A.Y., Liegl, M., Havens, P.L., Ray, K., Mitchell, M., & Graff, K. (2024). Safety of remdesivir in the treatment of acute SARS-CoV-2 infection in pediatric patients. BMC Infectious Diseases, 24, 987. https://doi.org/10.1186/s12879-024-09833-9

Romani, L., Roversi, M., Bernardi, S., Venturini, E., Garazzino, S., Donà, D., Krzysztofiak, A., Montagnani, C., Funiciello, E., Calò Carducci, F. I., Marabotto, C., Castagnola, E., Salvini, F., Lancella, L., Lo Vecchio, A., Galli, L., Castelli Gattinara, G., & Italian Society of Pediatric Infectious Diseases (SITIP) (2024). Use of remdesivir in children with COVID-19: Report of an Italian multicenter study. Italian journal of pediatrics, 50(1), 32. https://doi.org/10.1186/s13052-024-01606-z 

Samuel, A. M., Hacker, L. L., Zebracki, J., Bogenschutz, M. C., Schulz, L., Strayer, J., Vanderloo, J. P., Cengiz, P., & Henderson, S. (2023). Remdesivir use in pediatric patients for SARS-CoV-2 treatment: Single academic center study. The Pediatric Infectious Disease Journal, 42(4), 310–314. https://doi.org/10.1097/INF.0000000000003814

Shoji, K., Asai, Y., Akiyama, T., Tsuzuki, S., Matsunaga, N., Suzuki, S., Iwamoto, N., Funaki, T., Miyairi, I., & Ohmagari, N. (2023). Clinical efficacy of remdesivir for COVID-19 in children: A propensity-score-matched analysis. Journal of Infection and Chemotherapy: Official Journal of the Japan Society of Chemotherapy, 29(9), 930–933. https://doi.org/10.1016/j.jiac.2023.06.006

Spinner, C. D., Gottlieb, R. L., Criner, G. J., Arribas López, J. R., Cattelan, A. M., Soriano Viladomiu, A., Ogbuagu, O., Malhotra, P., Mullane, K. M., Castagna, A., Chai, L. Y. A., Roestenberg, M., Tsang, O. T. Y., Bernasconi, E., Le Turnier, P., Chang, S. C., SenGupta, D., Hyland, R. H., Osinusi, A. O., Cao, H., … GS-US-540-5774 Investigators (2020). Effect of remdesivir vs standard care on clinical status at 11 Days in patients with moderate COVID-19: A randomized clinical trial. JAMA, 324(11), 1048–1057. https://doi.org/10.1001/jama.2020.16349

These pathways do not establish a standard of care to be followed in every case. It is recognized that each case is different, and those individuals involved in providing health care are expected to use their judgment in determining what is in the best interests of the patient based on the circumstances existing at the time. It is impossible to anticipate all possible situations that may exist and to prepare a pathway for each. Accordingly, these pathways should guide care with the understanding that departures from them may be required at times.

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Remdesivir for Children with COVID-19