Keeley, Tom J. H. http://orcid.org/0000-0003-1584-9093
Satram, Sacha
Ghafoori, Parima
Reyes, Carolina
Birch, Helen J. http://orcid.org/0000-0002-4924-4810
Raymond, Kimberly
Gelhorn, Heather L.
Kosinski, Mark
Saucier, Cory D. http://orcid.org/0000-0002-0420-6458
Mitchell Foster, April
Lopuski, Amanda
Powers, John H. III
Clinical trials referenced in this document:
Documents that mention this clinical trial
Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO PlusĀ©) instrument in patients with COVID-19
https://doi.org/10.1007/s11136-022-03336-3
Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19
https://doi.org/10.1186/s41687-023-00621-8
Funding for this research was provided by:
GlaxoSmithKline (GSK study 215031, GSK study 215032)
Vir (Vir-7831-5001)
Article History
Accepted: 21 December 2022
First Online: 27 January 2023
Declarations
:
: TJHK, PG, HJB, and AL are employees of, and hold stocks/shares in, GSK. CR and SS are employees of, and hold stocks/shares in, Vir Biotechnology. KR, MK, CDS, and AMF are employees of QualityMetric Incorporated; QualityMetric Incorporated received funding from GSK to conduct part of this research and did not receive funding for manuscript development. HLG is an employee of Evidera; Evidera received funding from GSK to conduct part of this research and did not receive funding for manuscript development. JHP has served as a consultant for Arrevus, Eicos, Eli Lilly, Evofem, Eyecheck, Gilead, GlaxoSmithKline, Johnson & Johnson, Microbion, OPKO, Otsuka, Resolve, Romark, Shinogi, SpineBioPharma, UTIlity, and Vir.
: Ethics approval for the qualitative study was granted by the New England Independent Review Board (NEIRB). NEIRB reviewed and approved all qualitative study materials prior to the start of recruitment. Ethics approval for the psychometric evaluation was covered by the COMET-ICE trial (NCT04545060) IRB.
: All subjects who participated in the qualitative interviews were required to sign an informed consent form prior to interview. Use of patient data in the psychometric evaluation was covered under the COMET-ICE trial's ethical approval (NCT04545060).
: Consent to publish was included in the informed consent form subjects were required to sign before participating in the qualitative interviews. Publishing of patient data analyzed in the psychometric evaluation was covered under the COMET-ICE trial's ethical approval (NCT04545060).