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Antiviral
RV521 Capsules for Stem Cell Transplant Complications (REVIRAL2 Trial)
Phase 2
Waitlist Available
Research Sponsored by ReViral Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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/
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at visit 2/day 1 (pre-dose), visit 4/day 3, visit 6/day 14 and visit 8/day 28
Awards & highlights
REVIRAL2 Trial Summary
This trial is testing a new RSV drug for people who are at high risk for complications and have had a bone marrow transplant.
Eligible Conditions
- Stem Cell Transplant Complications
- Respiratory Syncytial Virus
- Lower Respiratory Tract Infection
REVIRAL2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREVIRAL2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at visit 2/day 1 (pre-dose), visit 4/day 3, visit 6/day 14 and visit 8/day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at visit 2/day 1 (pre-dose), visit 4/day 3, visit 6/day 14 and visit 8/day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in RSV nasal viral load (via RT-qPCR)
Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study
Secondary outcome measures
Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)
+21 moreREVIRAL2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RV521 CapsulesExperimental Treatment1 Intervention
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.
Group II: RV521 Placebo CapsulesPlacebo Group1 Intervention
RV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally.
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Who is running the clinical trial?
ReViral LtdLead Sponsor
4 Previous Clinical Trials
208 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,873 Total Patients Enrolled
Seth Hetherington, MDStudy DirectorReViral Ltd
1 Previous Clinical Trials
51 Total Patients Enrolled
Frequently Asked Questions
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