Upper Respiratory Tract InfectionPhase 2NCT00632463
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
A Phase 2 study testing RI-001 in people with Upper Respiratory Tract Infection and Lower Respiratory Tract Infection, run by ADMA Biologics, Inc. at 19 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Upper Respiratory Tract Infection, Lower Respiratory Tract Infection
- What is being tested?
- RI-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2008to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
- Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug.
- Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent.
- Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
- Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
- Patients must be actively taking at least one immunosuppressive agent.
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- Patients must have a positive RSV RT-PCR at the time of the randomization procedures.
- Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy.
- Female patients who are not breast-feeding.
- Patient/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedules or treatment regimen according to the judgment of the Investigator.
Who cannot join
- Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff.
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
- Unstable respiratory status so severe that survival is not expected for longer than 6 months.
- End organ dysfunction resulting in anticipated survival of less than 6 months.
- Known to be HIV positive.
- Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures.
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- Previous, current, or planned administration of an investigational RSV vaccine.
- Known hypersensitivity to immunoglobulin.
- Known Immunoglobulin (IgA) deficiency
- Known renal impairment requiring any form of dialysis (HD, PD, CRRT).
- Known hemodynamically significant congenital heart disease.
- Previous poor compliance with visit schedules.
- Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient.
- Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Johns Hopkins Medical Center
Baltimore, Maryland, 21205
New England Medical Center
Boston, Massachusetts, 02111
Rush University Medical Center
Chicago, Illinois, 60612
Children's Medical Center of Dallas
Dallas, Texas, 75235
Cook Children's Medical Center
Fort Worth, Texas, 76104
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Schneider Children's Hospital
New Hyde Park, New York, 11040
Oregon Health and Science University
Portland, Oregon, 97239
University of Rochester Medical Center
Rochester, New York, 14642
University of California San Francisco
San Francisco, California, 94143
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
All Children's Hospital
St. Petersburg, Florida, 33701
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Canada4 sites
Alberta Children's Hospital
Calgary, Alberta, T3B6A8
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T2M4
Hopital Sainte Justine
Montreal, Quebec, H3T1C5
Hospital for Sick Children
Toronto, Ontario, M5G1X8
About this study
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.
- Being tested
- RI-001
- Keywords
- Transplant, Immunosuppression
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RI-001Biological
Dose 1
RI-001Biological
Dose 2
RI-001Biological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose regimen 1 Receives: Biological: RI-001 |
| 2 | Experimental | Dose regimen 2 Receives: Biological: RI-001 |
| 3 | Placebo comparator | Placebo Receives: Biological: RI-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating RI-001 Titer
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.
Measured: Study day 18
Secondary outcomes (2)
Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
Measured: Study day 33
The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
Measured: 18 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADMA Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Upton Allen, MBBS, Principal investigator, Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632463
- Sponsor's protocol ID
- ADMA-001
- Status last verified
- Mar 2013
- First submitted
- 3 Mar 2008
- Last updated
- 24 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
- ClinicalTrials.gov ID
- NCT00632463
- Acronym / sponsor ID
- ADMA-001
- Keywords
- Transplant, Immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ADMA Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Posted 24 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: RI-001Dose regimen 1 |
| 2 | Experimental | Biological: RI-001Dose regimen 2 |
| 3 | Placebo comparator | Biological: RI-001Placebo |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
- Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug.
- Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent.
- Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
- Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
Key exclusion criteria (14 listed)
- Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff.
- Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
- Unstable respiratory status so severe that survival is not expected for longer than 6 months.
- End organ dysfunction resulting in anticipated survival of less than 6 months.
- Known to be HIV positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RI-001Dose 1 | Biological | 1 |
| RI-001Dose 2 | Biological | 2 |
| RI-001Placebo | Biological | 3 |
Primary outcome
Circulating RI-001 Titer
Time frame: Study day 18
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.
2 secondary outcomes
Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
Time frame: Study day 33
The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
Time frame: 18 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Upton Allen, MBBS principal investigator
Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RI-001 in people with Upper Respiratory Tract Infection and Lower Respiratory Tract Infection, run by ADMA Biologics, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating RI-001 Titer (time frame: Study day 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.