Study of RV521 for the treatment of adults who have received a blood cell transplant and that have a respiratory infection caused by the virus RSV

Phase 1

• Conditions: Symptomatic RSV infection (upper airway involvement only) in subjects who have undergone HCT transplantation within 1 year of Randomization and who are moderately to severely immunocompromised.; MedDRA version: 21.1Level: PTClassification code 10035732Term: Pneumonia respiratory syncytial viralSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: HLGTClassification code 10024970Term: Respiratory tract infectionsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: PTClassification code 10024968Term: Lower respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10065188Term: Lower respiratory tract infection viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003746-33-FR
• Lead Sponsor: ReViral Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-20
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1 Has undergone autologous or allogeneic HCT using any conditioning regimen within 1
year of randomization. Subjects who have undergone HCT more than 1 year before
Randomization are eligible if all other inclusion/exclusion criteria are satisfied and
under at least one of the following conditions:
a Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or
b Has used systemic corticosteroids in the 30 days prior to RSV infection
2 Has moderate to severe immunocompromise, defined as a score = 5 on the ISI-RSV
and/or an ALC of = 500 cells/ mm3
3 Documentation of positive RSV infection in the upper airway
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1 Use of non-marketed investigational agents within 30 days, OR use of an
investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of
screening, whichever is longer, OR use of any investigational RSV vaccines after HCT.
2 Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor
of CYP3A4, within 2 weeks of Randomization.
3 Receiving a prescription, OTC, or herbal medication that is a substrate of CYP3A4 with
a narrow therapeutic index where monitoring blood levels is not possible.
4 Known chronic infection with hepatitis B, C, or HIV.
5 Is in the pre-engraftment period during RSV infection.
6 Admitted to the hospital primarily for lower respiratory tract disease of any cause as
determined by the Investigator.
7 Any condition requiring mechanical ventilation or vasopressor support at the time of
randomization.
8 Clinically significant bacteremia or fungemia within 5 days prior to Screening that has
not been adequately treated.
9 Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to
Screening that has not been adequately treated.
10 Excessive nausea/vomiting at Screening or an inability to swallow capsules.
11 Elevation of hepatic enzymes or renal compromise.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified