Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00632463 · ClinicalTrials.gov registry record · Phase 2
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
A Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, sponsored by ADMA Biologics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 19
- Study locations
NCT00632463: Completed Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, sponsored by ADMA Biologics.
NCT00632463 is a Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection that has completed, run by ADMA Biologics. The registered enrollment target is 21 participants, below the 1,463-participant average among 3 other Lower Respiratory Tract Infection trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00632463, a Phase 2 study of Lower Respiratory Tract Infection and Upper Respiratory Tract Infection, has completed, sponsored by ADMA Biologics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 19
- Study locations
Study Summary
RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.
Primary Outcome
The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.
Conditions Studied
Interventions
- BIOLOGICAL RI-001
Study Locations (19)
New York
- Schneider Children's Hospital - New Hyde Park
- University of Rochester Medical Center - Rochester
Texas
- Children's Medical Center of Dallas - Dallas
- Cook Children's Medical Center - Fort Worth
Washington
- Seattle Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center - Seattle
Quebec
- Hopital Maisonneuve Rosemont - Montreal
- Hopital Sainte Justine - Montreal
California
- University of California San Francisco - San Francisco
Colorado
- University of Colorado Health Sciences Center - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00632463 record still lists
NCT00632463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,463-participant average among 3 other Lower Respiratory Tract Infection trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Lower Respiratory Tract Infection appearing as the primary indexed condition, and to 1 intervention - of which RI-001 is the first listed.
NCT00632463 lists 19 locations in 15 states (New York, Texas, Washington).
Frequently Asked Questions
What is clinical trial NCT00632463 about?
NCT00632463 is a clinical study titled "RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness". RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being in...
What is the current status of trial NCT00632463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-02. Estimated completion is 2010-05.
What conditions does trial NCT00632463 study?
This clinical trial studies the following conditions: Lower Respiratory Tract Infection, Upper Respiratory Tract Infection.
What interventions are being tested in trial NCT00632463?
The interventions under investigation include: RI-001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00632463?
This trial is sponsored by ADMA Biologics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00632463 being conducted?
This trial has 19 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lower Respiratory Tract Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
RECRUITING · NA
-
Reducing Overuse of Antibiotics With Decision Support
RECRUITING · NA
-
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia