Table 2.

Industry-Sponsored COVID-19 Drug and Vaccine National Clinical Trials (NCT) Found in www.clinicaltrials.gov Using Search Terms: COVID-19; Pediatric; Industry-sponsored.

# NCT No. Abbreviated Study Design Age (Number; Centers*) Status
1 04551547 R, DB, PC vaccine study 3–17y (n=552) Recruiting
2 04456439 EAP of HMSC for MIS-C 2mo–17y (n=~50) Available
3 04649151 PC mRNA-1273 Vaccine S, RG, E study 12–17y (n=3,000; 7 ctrs) Not yet recruiting
4 04431453 S, T, PK, E of remdesivir <17y (n=52; 30 ctrs) Recruiting
5 04646031 Open label EAP of T89 botanical drug C+A+OA Available
6 04368728 R, PC, BNT162b1 + BNT162b2 >12y (n=43,998; 155 ctrs) Recruiting
7 04362137 R, DB, PC ruxolitinib in CS >12y (n=432; 61 ctrs) Completed
8 04409262 R+T versus R+P in severe pneumonia >12y (n=500; 73 ctrs) Recruiting
9 04597047 MC diagnostic study C+A+OA (n=200) Recruiting
10 04355793 EAP ruxolitinib in CS >12y Recruiting
11 04377620 PC ruxolitinib in ventilated ARDS pts >12y (n=500; 35 ctrs) Recruiting
12 04362189 PC study of HB-adMSCs C+A+OA (n=100) Active non-recruiting
13 04486313 PC, S, E of nitazoxanide >12y (n=800) Recruiting
14 04427501 PC, R, LY-CoV555 + LY-CoV016 >12y (n=1,200) Recruiting
15 04292899 S, E of remdesivir in severe COVID-19 >12y (n=4,891; 183 ctrs) Completed
16 04501952 S, E of remdesivir in outpatients >12y (n=1,264; 45 ctrs) Recruiting
17 04377711 R, DB, PC ciclesonide in outpatients 12–100y (n=400) Recruiting
18 04348435 R, DB, PC, S, E, HB-adMSCs to protect against COVID-19 C+A+OA (n=100) Enrolling by invitation
19 04292730 Remdesivir vs. SoC >12y (n=1,113; 184 pts) Completed
20 04337359 Ruxolitinib MAP 6–90y Available
21 04362813 DB, PC, S, E canakinumab in pneumonia >12y (n=451) Active non-recruiting
22 04422509 Lanadelumab >16y (n=80; 10 ctrs) Recruiting
23 04566770 Vaccine study >6y (n=481) Recruiting
24 04471519 DB, PC, vaccine study 12–65y (n=755) Recruiting
25 04617535 Compassionate use REGN-COV2 C+A+OA Available
26 04603651 Bamlanivimab EAP >12y No longer available
27 04349631 HB-adMSCs to protect against COVID-19 C+A+OA (n=56) Active non-recruiting
28 04323761 EAP remdesivir >12y Approved for marketing
29 04360096 Inhaled aviptadil 12–85y (n=288) Not yet recruiting
30 04453839 Aviptadil EAP 12–100y (n=24) Available
31 03808922 PC, DAS181 (1 subgroup only) C+A+OA (n=274; 58 ctrs) Recruiting
32 04452318 PC, REGN10933+REGN10987 protection >12y (n=2,000) Recruiting
33 04579640 Open-label randomized vitamin D to reduce risk and severity of COVID-19 >16y (n=6,200) Active non-recruiting
*Number relates to patients or participants, as defined in the study; not all studies provided both number of patients and number of centers.

ARDS, acute respiratory distress syndrome; C+A+OA, child+adult+older adult; CS, cytokine storm; DB, double-blind; E, efficacy; EAP, expanded access program; HB-adMSCs, Hope Biosciences allogeneic adipose-derived mesenchymal stem cells; HMSC, human mesenchymal stromal cells; MAP, managed access program; MC, multicenter; MIS-C, multisystem inflammatory syndrome in children; mo, months; PC, placebo-controlled; PK, pharmacokinetics; R, remdesivir; R+P, remdesivir+placebo; R+T, remdesivir+tocilizumab; RG, reactogenicity; S, safety; SoC, standard of care; T, tolerability; y, years.

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2021 April; 12(2): e0010. ISSN: 2076-9172
Published online 2021 April 29. doi: 10.5041/RMMJ.10433.