CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
RI-001 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00632463
NCT00632463Phase 2Completed
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RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

ADMA Biologics, Inc.·interventional·Posted Mar 10, 2008·Updated Apr 24, 2013

In Brief

A Phase 2 clinical trial evaluating RI-001 for Upper Respiratory Tract Infection and Lower Respiratory Tract Infection. Completed, enrolled 21 participants across 19 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Respiratory Tract Infection, Lower Respiratory Tract Infection
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2008
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.3 years ago

Interventions

RI-001biological

Dose 1

RI-001biological

Dose 2

RI-001biological

Placebo