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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04267822




Registration number
NCT04267822
Ethics application status
Date submitted
5/02/2020
Date registered
13/02/2020

Titles & IDs
Public title
Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV
Scientific title
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)
Secondary ID [1] 0 0
C5241011
Secondary ID [2] 0 0
REVC006
Universal Trial Number (UTN)
Trial acronym
REVIRAL2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ototoxicity 0 0
RSV Infection 0 0
Stem Cell Transplant Complications 0 0
Lower Resp Tract Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RV521 oral tablet
Treatment: Drugs - Placebo oral tablet
Treatment: Drugs - DB-020

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.

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

Active comparator: DB-020 for Injection, 12%/placebo - dosage

Active comparator: DB-020 for Injection, 25%/placebo - dosage


Treatment: Drugs: RV521 oral tablet
Each RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)

Treatment: Drugs: Placebo oral tablet
Each placebo dose is four capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)

Treatment: Drugs: DB-020
Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study
Timepoint [1] 0 0
Pre-dose baseline (Day 1) through Visit 8 (Day 28)
Primary outcome [2] 0 0
Change in RSV nasal viral load (via RT-qPCR)
Timepoint [2] 0 0
Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Secondary outcome [1] 0 0
Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs
Timepoint [1] 0 0
First dose of study drug through Visit 8 (Day 28)
Secondary outcome [2] 0 0
Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters)
Timepoint [2] 0 0
Baseline through Visit 8 (Day 28)
Secondary outcome [3] 0 0
Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)
Timepoint [3] 0 0
Baseline through Visit 8 (Day 28)
Secondary outcome [4] 0 0
Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)
Timepoint [4] 0 0
Baseline through Visit 8 (Day 28)
Secondary outcome [5] 0 0
Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)
Timepoint [5] 0 0
Baseline through Visit 8 (Day 28)
Secondary outcome [6] 0 0
Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI
Timepoint [6] 0 0
Baseline through Visit 8 (Day 28)
Secondary outcome [7] 0 0
Evaluate the proportion of subjects with changes and shifts in hematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline.
Timepoint [7] 0 0
Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28
Secondary outcome [8] 0 0
Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline
Timepoint [8] 0 0
Measurements will be taken at Day 1/Visit 2 (pre-dose and at 5-hours post-dose), on Day 3/Visit 4 (at 5 hours post-dose), and at Visit 6 (Day 14)
Secondary outcome [9] 0 0
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR
Timepoint [9] 0 0
Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Secondary outcome [10] 0 0
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA
Timepoint [10] 0 0
Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Secondary outcome [11] 0 0
Mean change in RSV viral load assessed via CBIA
Timepoint [11] 0 0
Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Secondary outcome [12] 0 0
Mean change from baseline in viral RNA shedding
Timepoint [12] 0 0
Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Secondary outcome [13] 0 0
Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA at each timepoint
Timepoint [13] 0 0
Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Secondary outcome [14] 0 0
Time to improvement in RSV-related symptoms
Timepoint [14] 0 0
Daily from baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [15] 0 0
Time to total resolution of all RSV-related symptoms
Timepoint [15] 0 0
Daily from baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [16] 0 0
Proportion of days with lowest daily SpO2 = 90% on room air
Timepoint [16] 0 0
Daily from baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [17] 0 0
Number of days where supplementary oxygen was required
Timepoint [17] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [18] 0 0
Proportion of subjects who require hospitalization during the study
Timepoint [18] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [19] 0 0
Mean number of days of hospitalization during the study
Timepoint [19] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [20] 0 0
Proportion of subjects requiring ICU
Timepoint [20] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [21] 0 0
Mean number of days in ICU
Timepoint [21] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [22] 0 0
Proportion of subjects requiring mechanical ventilation
Timepoint [22] 0 0
Baseline (Day 1) through Visit 8 (Day 28)
Secondary outcome [23] 0 0
Number of subjects who experience death (all-cause mortality)
Timepoint [23] 0 0
First dose of study drug through Visit 8 (Day 28)
Secondary outcome [24] 0 0
Number of subjects who experience death attributable to LRTC
Timepoint [24] 0 0
First dose of study drug through Visit 8 (Day 28)

Eligibility
Key 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:

1. Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or
2. 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/06/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
PfizerCT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04267822