EUCTR2014-002137-58-GB进行中（未招募）1 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •An informed consent document signed and dated by the subject or a legal guardian of the subject and Investigator or his/her designee
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
- •Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation while enrolled in the study and for at least 90 days after administration of the last dose of study medication.
- •All subjects must refrain from blood donation while enrolled in the study and for 30 days after the last dose of IMP.
- •= 18 years of age at Screening
- •Willing to adhere to protocol specific requirements for contraception
- •Subject is a current inpatient
- •New onset of acute respiratory infectious symptoms, or acute worsening of chronic symptoms related to ongoing respiratory disease for = 5 days prior to screening:
- •Upper respiratory tract symptoms: Nasal congestion, runny nose, sore throat, or earache
- •Lower respiratory tract symptoms: Cough, sputum production, wheezing, dyspnea, or chest tightness
- •Willingness to perform necessary study procedures and have available a working telephone or email
- •Documented to be RSV-positive as per protocol Section 6.1.1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Related to concomitant or previous medication use:
- •- Use of any investigational medicinal product in the 28 days prior to screening, OR use of any investigational monoclonal antibody within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccine ever
- •- Chronic use (> 28 days of use) of systemic immunosuppressive agents (i.e. alkylating agents, calcineurin inhibitors, immunophilin-binding but not a calcineurin inhibitor, antimetabolites, polyclonal antibodies, monoclonal antibodies) during the 28 days prior to Screening, or anticipated use during the 28 days following Screening
- •-Use of oral prednisone or other corticosteroid equivalent to:
- •- > 20 mg/day > 14 days prior to screening is not permitted.
- •- > 20 mg/day = 14 days, including corticosteroids received during current hospitalisation (ie bolus doses) is permitted.
- •- = 20 mg/day, regardless of duration is permitted.
- •- Subjects taking a moderate or strong cytochrome P450 (CYP) enzyme inducer including but not limited to rifampin, St John’s wort, carbamazepine, and phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin within 2 weeks prior to the first dose of IMP
- •Related to medical history:
- •-Pregnant, breastfeeding, or lactating females
- •-Subjects requiring > 50% supplemental oxygen (while the subject is awake) at Screening
- •- Subjects with a CFS > 7 at Baseline
- •-Known significant abnormality altering the anatomy of the nose or nasopharynx that in, the opinion of the investigator, will preclude obtaining adequate nasal swab sampling in either nasal passage
- •-Waiting for or recently (within the past 12 months) received a bone marrow, stem cell, or solid organ transplant, or who have received radiation or chemotherapy within 12 months prior to screening
- •- Subjects with HIV/AIDS and a known CD4 count < 200 cells / µl
- •-History of severe dementia or Alzheimer’s disease
- •- History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
- •Related to medical condition:
- •- Influenza-positive as determined by local diagnostic test
- •- Known MERS-CoV infection or known coinfection with other coronavirus
- •-Use of mechanical ventilation during the current admission, not including noninvasive ventilation
- •- Clinically significant bacteremia or fungemia that has not been adequatly treated prior to screening, as determined by the investigator
- •- Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as determined by the investigator
- •- Excessive nausea/vomiting at admission, as determined by the investigator, that precludes administration of an orally administered IMP
- •-Subjects with an unstable medical condition, as determined by the investigator, that preclude participation in the study
- •Related to allergies:
- •- Known allergy to components of the IMP (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc).
- •- Documented history of acute (anaphyl
研究者
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