About: A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

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About: A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
Creator	Boeckh, Michael Kim, Yae-Jean Waghmare, Alpana Ljungman, Per Jordan, Robert Shoham, Shmuel Guo, Ying Lee, Dong-Gun Hirsch, Hans Bergeron, Anne Porter, Danielle Chemaly, Roy Small, Catherine Watkins, Timothy Chien, Jason Blanchard, Elodie Dadwal, Sanjeet German, Polina Marty, Francisco Mckevitt, Matt Mullane, Kathleen
Source	PMC
abstract	BACKGROUND: Presatovir significantly reduced nasal viral load, signs, and symptoms of respiratory syncytial virus (RSV) infection in a human challenge study. We evaluated presatovir in hematopoietic-cell transplant (HCT) recipients with RSV lower respiratory tract infection (LRTI). METHODS: Patients with confirmed RSV in upper and lower respiratory tract and new chest X-ray abnormalities were randomized (1:1), stratified by supplemental oxygen and ribavirin use, to receive oral presatovir 200 mg or placebo every 4 days for 5 doses. The primary endpoint was time-weighted average change in nasal RSV viral load through day 9. Secondary endpoints included supplemental oxygen-free days, incident respiratory failure requiring mechanical ventilation, and all-cause mortality. RESULTS: From January 31, 2015, to March 20, 2017, 60 patients from 17 centers were randomized (31 presatovir, 29 placebo); 59 received study treatment (50 allogeneic, 9 autologous HCT). In the efficacy population (29 presatovir, 28 placebo), presatovir treatment did not significantly reduce time-weighted average change in viral load (−1.12 vs −1.09 log(10) copies/mL; treatment difference −0.02 log(10) copies/mL, 95% confidence interval: −.62, .57; P = .94), median supplemental oxygen-free days (26 vs 28 days, P = .84), incident respiratory failure (10.3 vs 10.7%, P = .98), or all-cause mortality (0 vs 7.1%, P = .19) versus placebo. Adverse events were similar between arms (presatovir 80%, placebo 79%). Resistance-associated substitutions in RSV fusion protein emerged in 6/29 presatovir-treated patients. CONCLUSIONS: Presatovir treatment was well tolerated in HCT patients with RSV LRTI but did not improve virologic or clinical outcomes versus placebo. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov, NCT02254421; EudraCT, #2014-002475-29
has issue date	2019-12-03(xsd:dateTime)
bibo:doi	10.1093/cid/ciz1167
bibo:pmid	31915807
has license	cc-by-nc-nd
sha1sum (hex)	bbb35eef3b6121c337dba0f92d136c339b76328d
schema:url	https://doi.org/10.1093/cid/ciz1167
resource representing a document's title	A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
has PubMed Central identifier	PMC7108198
has PubMed identifier	31915807
schema:publication	Clin Infect Dis
resource representing a document's body	covid:bbb35eef3b6121c337dba0f92d136c339b76328d#body_text
is schema:about of	named entity 'PRESATOVIR' named entity 'NASAL' named entity 'CELL TRANSPLANT' named entity 'HUMAN' named entity 'BACKGROUND' named entity 'MULTICENTER STUDY' named entity 'EFFECTS' covid:arg/bbb35eef3b6121c337dba0f92d136c339b76328d named entity 'CLINICAL' named entity 'RANDOMIZED' named entity 'SIGNS' named entity 'LOWER RESPIRATORY TRACT' named entity '2019' named entity 'PLACEBO-CONTROLLED' named entity 'DOUBLE' named entity 'LOWER RESPIRATORY TRACT INFECTION' named entity 'EVALUATED' named entity 'HEMATOPOIETIC' named entity 'RESPIRATORY SYNCYTIAL VIRUS' named entity 'TOLERABILITY' named entity 'PHASE 2B' named entity 'PHARMACOKINETICS' named entity 'SAFETY' named entity 'ANTIVIRAL' named entity 'EVALUATING' named entity 'TRANSPLANT RECIPIENTS' named entity 'CHALLENGE STUDY' named entity 'VIRAL LOAD' named entity 'INFECTIOUS DISEASES' named entity 'HEMATOPOIETIC CELL' named entity 'CELL TRANSPLANT' named entity 'INFECTION' named entity 'REDUCED' named entity 'BLIND' named entity 'INFECTION' named entity 'RESPIRATORY SYNCYTIAL VIRUS' named entity 'SYMPTOMS' named entity 'PRESATOVIR' named entity 'RSV' named entity 'study' named entity 'human' named entity 'RSV' named entity 'RSV' named entity 'Presatovir' named entity 'Clinical Infectious Diseases' named entity 'Infection' named entity 'Multicenter' named entity 'viral disease' named entity 'oxygen saturation' named entity 'URTI' named entity 'Acute kidney injury' named entity 'reverse transcription' named entity 'RSV infection' named entity 'GVHD' named entity 'infection' named entity 'lower respiratory tract' named entity 'presatovir' named entity 'bronchoalveolar lavage' named entity 'placebo' named entity 'viral load' named entity 'RSV infection'

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