A clinical trial investigating the anti-virus effects, kinetics and safety of GS-5806 in adults with RSV (respiratory syncytial virus) infectio

Phase 2

• Conditions: Infecção por vírus sincicial respiratório (VSR) do trato respiratório superior. Diseases of the respiratory system. Acute upper respiratory infection, unspecified. Respiratory syncytial virus as the cause of diseases classified to other chapters.; J06.9; B97.4

• Registration Number: RBR-4hm9bf
• Lead Sponsor: Fundação Doutor Amaral Carvalho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Received an autologous or allogeneic hematopoietic cell transplantation (HCT) using any conditioning regimen; Documented to be RSV-positive (respiratory syncytial virus) as determined by local testing for example, PCR (polymerase chain reaction), DFA (direct fluorescent antibody), RVP (respiratory virus pannel) assay, or culture using an upper respiratory tract sample collected 6 days or less prior to Day 1; New onset of at least 1 of the following respiratory symptoms for 7 days or less prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic respiratory symptoms 7 days or less prior to Day 1; No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care 48 hours or less prior to Screening, a chest X-ray must be obtained for Screening; O2 saturation equal or higher than 92% on room air; An informed consent document signed and dated by the subject or a legal guardian of the subject and the investigator or his or her designee; A negative urine or serum pregnancy test is required for female subjects, unless surgically sterile or greater than two years post-menopausal; Male and female subjects of childbearing potential must agree to contraceptive requirements as described in Appendix 5; Willingness to complete necessary study procedures and have available a working telephone or email.

Exclusion Criteria

Related to concomitant or previous medication use: Use of non-marketed according to region investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whicheveris longer, OR use of any investigational RSV vaccines after HCT; Use of a strong cytochrome P450 enzyme inducer including but not limited to rifampin, St. John’s Wort, carbamazepine, and phenytoin, within 2 weeks prior to the first dose of IMP; Related to medical history: Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator; Pregnant, reastfeeding, or lactating females; Unable to tolerate nasal sampling required for this study, as determined by the investigator; Known history of HIV and or AIDS with a CD4 count <200 cells/microL within the last month; History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities; Related to medical condition at Screening: A relapse, including molecular relapse, of the underlying disease for which they received a transplant at Screening; Documented to be positive for other respiratory viruses limited to influenza, parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus within 7 days prior to the Screening visit, as determined by local testing; Clinically significant bacteremia or fungemia within 7 days prior to Screening that has not been adequately treated, as determined by the investigator; Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated, as determined by the investigator; Excessive nausea/vomiting at Screening, as determined by the investigator, or an inability to swallow pills that precludes oral administration of the IMP; Any condition which, in the opinion of the investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints; Related to allergies: Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients like microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc; Allergy to sulfa drugs; Related to laboratory results: Creatinine clearance lesser than 30 mL/min, calculated using the Cockcroft-Gault method; AST/ALT higher than 3x ULN; Total bilirubin higher than 3x ULN.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR of nasal samples. To test the null hypothesis that there is no difference between the GS-5806 and placebo treatment groups in the time-weighted average change in viral load, a parametric analysis of covariance (ANCOVA) model with corresponding Baseline viral load as a covariate will be used, with a 2 sided 0.05 level. Adjusted means and 95% confidence intervals (CIs) will also be presented.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who develop a lower respiratory tract complication (LRTC) through Day 28, defined as one of the below as determined by the adjudication committee: Primary RSV lower respiratory tract infection (LRTI); Secondary bacterial LRTI; LRTI due to unusual pathogens; LRTI, noninfectious or of unknown etiology. The comparison between groups is performed using Fisher’s exact test. ;Proportion of subjects developing respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) through Day 28. The need for mechanical ventilation is assessed clinically. The comparison between groups is performed using Fisher’s exact test. ;Proportion of subjects whose oxigen saturation drops below 92% through Day 28. O2 saturation is measured by pulse oximetry or arterial blood gas. The comparison between groups is performed using Fisher’s exact test.