Hospital Costa del Sol | Internal Medicine
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About
This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects with confirmed RSV infection who are at high risk for complications after RSV infection.
Enrollment
Sex
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Volunteers
Inclusion criteria
At least one of the following conditions that predispose them to complications after RSV infection:
The subject has a new onset of any of the following symptom(s) or worsening of pre-existing symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath.
The subject reports at least 2 of the following symptoms, one of which must be reported as at least 'moderate' severity: cough, cough with phlegm, wheezing, or short of breath
The subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample.
A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups, including a placebo group
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Central trial contact
Enanta Pharmaceuticals, Inc
Data sourced from clinicaltrials.gov
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