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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
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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)
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Secondary ID [1]
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C5241011
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Secondary ID [2]
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REVC006
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Universal Trial Number (UTN)
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Trial acronym
REVIRAL2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ototoxicity
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RSV Infection
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Stem Cell Transplant Complications
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Lower Resp Tract Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study
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Assessment method [1]
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Progression to LRTC during the study defined as one of the following:
* Primary LRTI caused by RSV
* Secondary bacterial LRTI
* LRTI caused by another pathogen
* LRTC of unknown etiology
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Timepoint [1]
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Pre-dose baseline (Day 1) through Visit 8 (Day 28)
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Primary outcome [2]
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Change in RSV nasal viral load (via RT-qPCR)
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Assessment method [2]
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RSV change measured by the time-weighted average (DAVG) viral load using RT qPCR
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Timepoint [2]
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Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
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Secondary outcome [1]
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Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs
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Assessment method [1]
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Safety analyses will include a summary of AEs, including but not limited to n (%) of subjects in each treatment group and overall.
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Timepoint [1]
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First dose of study drug through Visit 8 (Day 28)
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Secondary outcome [2]
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Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters)
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Assessment method [2]
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BP will be collected in mm Hg. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
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Timepoint [2]
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Baseline through Visit 8 (Day 28)
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Secondary outcome [3]
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Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)
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Assessment method [3]
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Body Temperature will be collected in degrees Fahrenheit (°F) or degrees Celsius (°C). Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
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Timepoint [3]
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Baseline through Visit 8 (Day 28)
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Secondary outcome [4]
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Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)
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Assessment method [4]
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Respiration rate will be measured in breaths per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
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Timepoint [4]
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Baseline through Visit 8 (Day 28)
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Secondary outcome [5]
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Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)
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Assessment method [5]
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Heart rate will be measured in beats per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
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Timepoint [5]
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Baseline through Visit 8 (Day 28)
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Secondary outcome [6]
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Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI
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Assessment method [6]
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Weight and height will be collected and combined to report BMI
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Timepoint [6]
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Baseline through Visit 8 (Day 28)
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Secondary outcome [7]
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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.
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Assessment method [7]
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Results at each visit will be summarized using the statistics n, mean, standard deviation, median, minimum and maximum. Also, change from baseline will also be summarized by post baseline visits.
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Timepoint [7]
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Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28
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Secondary outcome [8]
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Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline
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Assessment method [8]
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ECGs will be taken with a centrally supplied ECG machine and electronically transmitted to a central ECG repository. ECG will only be evaluated by the Investigator for normal, abnormal NCS and abnormal CS.
Parameters collected will be:
* Ventricular Heart Rate (bpm)
* PR Interval (msec)
* QRS Interval (msec)
* QT Interval (msec)
* QTcB Interval (msec)
Results at each visit will be summarized using the statistics: n (number of observations), mean, SD, median, minimum and maximum.
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Timepoint [8]
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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)
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Secondary outcome [9]
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Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR
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Assessment method [9]
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Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by RT-qPCR.
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Timepoint [9]
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Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
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Secondary outcome [10]
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Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA
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Assessment method [10]
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Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by CBIA.
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Timepoint [10]
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Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
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Secondary outcome [11]
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Mean change in RSV viral load assessed via CBIA
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Assessment method [11]
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change measured by the time weighted average (DAVG) viral load using CBIA
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Timepoint [11]
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Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
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Secondary outcome [12]
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Mean change from baseline in viral RNA shedding
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Assessment method [12]
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RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.
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Timepoint [12]
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Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
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Secondary outcome [13]
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Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA at each timepoint
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Assessment method [13]
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RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.
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Timepoint [13]
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Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
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Secondary outcome [14]
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Time to improvement in RSV-related symptoms
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Assessment method [14]
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Defined as all symptoms present at initiation of therapy are mild or no longer present. (absent/resolved)
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Timepoint [14]
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Daily from baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [15]
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Time to total resolution of all RSV-related symptoms
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Assessment method [15]
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Defined as all symptoms are no longer present.
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Timepoint [15]
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Daily from baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [16]
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Proportion of days with lowest daily SpO2 = 90% on room air
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Assessment method [16]
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SpO2 measured at every visit. For subjects on oxygen or who are mechanically ventilated may have this waived.
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Timepoint [16]
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Daily from baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [17]
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Number of days where supplementary oxygen was required
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Assessment method [17]
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Use of daily supplementary oxygen will be collected throughout the study.
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Timepoint [17]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [18]
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Proportion of subjects who require hospitalization during the study
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Assessment method [18]
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Daily hospitalization utilization will be collected
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Timepoint [18]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [19]
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Mean number of days of hospitalization during the study
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Assessment method [19]
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Daily hospitalization utilization will be collected
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Timepoint [19]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [20]
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Proportion of subjects requiring ICU
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Assessment method [20]
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Daily ICU utilization will be collected
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Timepoint [20]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [21]
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Mean number of days in ICU
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Assessment method [21]
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Daily ICU utilization will be collected
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Timepoint [21]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [22]
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Proportion of subjects requiring mechanical ventilation
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Assessment method [22]
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Daily mechanical ventilation requirements will be collected
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Timepoint [22]
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Baseline (Day 1) through Visit 8 (Day 28)
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Secondary outcome [23]
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Number of subjects who experience death (all-cause mortality)
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Assessment method [23]
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Patient outcome will be followed and collected
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Timepoint [23]
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First dose of study drug through Visit 8 (Day 28)
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Secondary outcome [24]
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Number of subjects who experience death attributable to LRTC
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Assessment method [24]
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Patient outcome will be followed and collected
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Timepoint [24]
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First dose of study drug through Visit 8 (Day 28)
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/06/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2023
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Eligible subjects are adults with a documented symptomatic RSV infection who have undergone HCT transplantation and are moderately to severely immunocompromised. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 or placebo, twice daily for 10 days.
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Trial website
https://clinicaltrials.gov/study/NCT04267822
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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PfizerCT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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