Table 4 Summary of previous studies of RDV adverse effects (select) in pediatric patients
| Â | Mendez-Echevarria et al. (2020) [20] | Goldman et al. (2021) [16] | CARAVAN study, interim results (2022) [14] | Manabe et al. (2022) [18] | Jugulete et al. (2023) [19] | Samuel et al. (2023) [15] |
|---|---|---|---|---|---|---|
Methodology and study sample | Multicenter observational study of children < 16 y/o approved for compassionate-use RDV during March 2020 | Multicenter observational study of children < 18 y/o approved for compassionate-use RDV from March to April 2020 | Multicenter, phase 2/3 single arm, open-label study of children < 18 y/o | Single-center, retrospective observational study of patients ≤ 19 y/o with mild-severe COVID-19 from February to June 2020 | Single-center, retrospective cohort study of patients < 18 y/o with mild-severe COVID-19 who received RDV vs. symptomatic treatment alone†from July 2020 to September 2022 | Single-center, retrospective observational study of patients < 18 y/o with severe COVID-19 from October 2020 to February 2022 |
Country | Spain | International (USA, Spain, UK, Italy, France, Germany) | International (USA, Spain, UK, Italy) | Japan | Romania | USA |
Sample size (n) | 8 | 77 | 53 | 20 | 126 | 48 |
Patients on invasive respiratory support at baseline | 4 (50) | 39 (51) | 12 (23) | 0 | 0 | 0 |
Maximum duration of RDV (days) | 10 | 10 | 10 | 10 | 10 | 5 |
Adverse event, n (%) | Â | Â | Â | Â | Â | Â |
 Hypotension | 0 | - | - | 0 | - | - |
 Hypertension | 0 | 1 (1) | 4 (8) | 0 | - | 26 (54) |
 Bradycardia | 0 | 1 (1) | 3 (6) | 0 | - | 6 (13) |
 Acute kidney injury | 0 | 1 (1) | 6 (11) | 0 | 0 | 0 |
 AST increased | 0 | 4 (5) | - | 4 (20) | 78 (62)* | 0* |
 ALT increased | 0 | 5 (7) | 4 (8)* | 3 (15) | 68 (54)* | 0* |
 Serious AE | 0 | 12 (16)** | 0 | 0 | 0 | 0 |
 Discontinued RDV | 0 | 5 | 2 | 0 | 0 | - |