Ferrero, Fernando http://orcid.org/0000-0001-6335-0102
Lin, Chien-Yu http://orcid.org/0000-0003-4630-8724
Liese, Johannes
Luz, Kleber http://orcid.org/0000-0003-3025-0660
Stoeva, Tatyana
Nemeth, Agnes
Gijón, Manuel
Calvo, Cristina http://orcid.org/0000-0002-6503-3423
Natalini, Silvina http://orcid.org/0000-0001-5257-547X
Toh, Teck-Hock
Deleu, Sofie http://orcid.org/0009-0004-1272-8477
Chen, Bohang
Rusch, Sarah
Sánchez, Beatriz López
Leipoldt, Illse
Vijgen, Leen http://orcid.org/0000-0002-4356-2199
Huntjens, Dymphy
Baguet, Tristan
Bertzos, Kristi
Gamil, Mohamed
Stevens, Marita http://orcid.org/0000-0001-5233-8917
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
CROCuS, a Phase II Study Evaluating the Antiviral Activity, Clinical Outcomes, and Safety of Rilematovir in Children Aged ≥ 28 Days and ≤ 3 Years with Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus
https://doi.org/10.1007/s40272-024-00625-x
Funding for this research was provided by:
Janssen Research & Development
Article History
Accepted: 6 March 2024
First Online: 22 April 2024
Declarations
:
: The study was sponsored by Janssen Research & Development.
: Fernando Ferrero, Chien-Yu Lin, Kleber Luz, Tatyana Stoeva, Agnes Nemeth, Cristina Calvo, and Silvina Natalini have no conflicts of interest that are directly relevant to the content of this article. Johannes Liese received study grants for participation in the CROCuS trial. Manuel Gijón has received a public research grant from a public health institution (Instituto de Salud Carlos III, Madrid, Spain) to develop research tasks, with no conflicts of interests with the present study. Teck-Hock Toh received financial support from the study sponsor for travel to an investigator meeting prior to beginning the study. Sofie Deleu, Sarah Rusch, Leen Vijgen, and Mohamed Gamil are employees of Janssen Research & Development and may own stock or stock options. Bohang Chen is a prior employee of Janssen Research & Development and is a current employee of Bristol Myers Squibb. Beatriz López Sánchez is an employee of Janssen Research & Development under the legal entity Janssen Vaccines & Prevention B.V. Illse Leipoldt is an employee of Janssen-Cilag Pharmaceutical South Africa. Dymphy Huntjens is a prior employee of Janssen Research & Development and is a current employee of Priothera SAS and may own stock or stock options. Tristan Baguet is an employee of Janssen Research & Development. Kristi Bertzos is an employee of Janssen Global Services and holds stock options. Marita Stevens is a prior employee of Janssen Research & Development and may own stock or stock options.
: The final trial protocol and amendments were approved by an independent ethics committee or institutional review board at participating sites. The trial was conducted in compliance with the principles of the Declaration of Helsinki and the International Council for Harmonisation Guidelines on Good Clinical Practice.
: Written informed consent was provided by patients’ parents/legal guardians.
: Not applicable.
: The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at ExternalRef removed. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at ExternalRef removed.
: Not applicable.
: FF, C-YL, JL, KL, TS, AN, MaG, CC, SN, T-HT, SD, BC, SR, BLS, LV, DH, TB, MoG, and MS participated in the conception and design of the study. Material preparation, data collection, and analyses were performed by SD, SR, BLS, IL, LV, KB, and MS. Study center monitoring and data analysis were performed by the sponsor. Medical writers, funded by the sponsor, assisted with manuscript drafting. All authors provided input on previous drafts of the manuscript, approved the final version, and vouch for the accuracy and completeness of the data.