Etude : REVIRAL2 / REVC006

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : REVIRAL2 / REVC006

Situation thérapeutique : Greffe

Traitement :

Cadre réglementaire : RIPH2

Dernière MÀJ : 24/06/2022
CIM10 - Localisation(s)
Informations principales
Titre : Randomized, double-blind, placebo-controlled trial of the safety, tolerability, and efficacy of RV521 in the treatment of adult subjects who have undergone hematopoietic cell transplantation (HCT) with a documented upper respiratory tract infection (URTI) with respiratory syncytial virus (RSV)

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Informations complémentaires
Schéma : Study design:
The purpose of this study is to compare the viral load, safety, tolerability, and clinical efficacy of RV521 compared to placebo. This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study. Up to 200 adult subjects with a documented symptomatic RSV URTI who have undergone HCT within 1 year of randomization and who are moderately to severely immunocompromised will be randomized.

Qualified subjects will be randomized in a 1:1 ratio to receive RV521 capsules or matching placebo twice daily for 10 days. After the completion of the 10-day double-blind treatment period, subjects will be followed for an additional 28 days. Study drug may be taken on an outpatient or inpatient basis, depending on clinical status and site practices. Randomization will be stratified by type of HCT graft and ALC count. There are 9 clinic visits planned for this study.

Study arms:
- Experimental: RV521 Capsules
RV521 is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. They are a white, opaque capsule and administered orally.
Each RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)

- Placebo Comparator: RV521 Placebo Capsules
RV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally.

Main objective:
- To evaluate clinical improvement relative to placebo, defined as the proportion of subjects who do not experience lower respiratory tract complications (LRTC) during the study period
- To compare the anti-viral activity of RV521 to that of placebo, measured by time weighted average change in viral load (DAVG) measured by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) from nasal swab samples.

Secondary objectives:
- To evaluate clinical improvement relative to placebo as defined by duration of RSV-related symptoms over 28 days
- To evaluate the anti-viral effect of RV521 defined as the timeweighted average change in viral load (DAVG) measured by a cell-based infectivity assay (CBIA) from nasal swab samples
- To evaluate the proportion of days with lowest daily pulse oximetry oxygen saturation (SpO2) ≥ 90% on room air
- To evaluate the requirements for respiratory supportive measures (oxygen and/or mechanical ventilation) and hospitalization/intensive care unit (ICU) utilization
- To compare the rates of mortality between subjects receiving RV521 to those receiving placebo
- To evaluate the safety and tolerability of RV521 in subjects with RSV URTI
- To evaluate of the pharmacokinetics/pharmacodynamic (PK/PD) relationship of RV521 treatment in adults with RSV URTI.

Phase : II

Stade : NA

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 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

Critères de non-inclusion : 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.
Informations relatives au promoteur
Promoteur :
ReViral Ltd
Type de sponsor : Industriel
ReViral Ltd - test

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur David BEAUVAIS

Secrétariat de recherche

Statut de l'essai : CLOS

MAJ : 24/06/2022