RSV Illness in ≤12 Months of ParticipantsNCT00421304

A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

A study testing Motavizumab in people with RSV Illness in ≤12 Months of Participants, run by MedImmune LLC at 35 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness. Read more about this study

Who is it for?: Ages 0 to 12 months
Conditions the study is for: RSV Illness in ≤12 Months of Participants
What is being tested?: Motavizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 118 participants
Where: 35 sitesin 5 countries
Study dates: 10 Jan 2007to 17 Sep 2009
Phase: Interventional
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 0 to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Children must meet all of the following criteria:
Previously healthy
Age less or equal to 12 months at the time of randomization
Gestational age more or equal to 36 weeks
Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
Documented positive RSV test within 48 hours prior to randomization
Randomization within 12 hours of the decision to hospitalize a child for RSV illness
Written informed consent obtained from the participant's parent(s)/legal guardian

Who cannot join

Children must have none of the following:
Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
Any use of systemic or inhaled steroids within the past 30 days prior to randomization
Intubation for ventilatory support at randomization
Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency

Show all 13Show fewer

Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
Mechanical ventilation at any time prior to the onset of the current RSV infection
Congenital heart disease [children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
Previous reaction to IVIG, blood products, or other foreign proteins
Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Trial locations and contacts

35 sites in 5 countries.

Country

City, postcode or hospital

35 sites in 5 countries

United States26 sites

Research Site
Boston, Massachusetts, 02111
Research Site
Brooklyn, New York, 11201
Research Site
Buffalo, New York, 14222
Research Site
Chicago, Illinois, 60612
Research Site
Columbus, Ohio, 43205
Research Site
Dallas, Texas, 75390
Research Site
Honolulu, Hawaii, 96826
Research Site
Houston, Texas, 77030
Research Site
Jackson, Mississippi, 39216-4505
Research Site
Jacksonville, Florida
Research Site
Long Beach, California, 90806
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Mineola, New York, 11501
Research Site
Morgantown, West Virginia, 26506
Research Site
New Hyde Park, New York, 11040
Research Site
Oak Lawn, Illinois, 60453
Research Site
Oklahoma City, Oklahoma, 73104-5066
Research Site
Omaha, Nebraska, 68198
Research Site
Orange, California, 92868
Research Site
Portland, Oregon, 97239
Research Site
Rochester, New York, 14642
Research Site
Salt Lake City, Utah, 84108
Research Site
San Diego, California, 92123
Research Site
Seattle, Washington, 98105
Research Site
Syracuse, New York, 13210
Research Site
Tucson, Arizona, 85724

Other trials in United States

Chile4 sites

Research Site
Independencia
Research Site
Santiago, 8360160
Research Site
Santiago, 8380418
Research Site
Santiago

Other trials in Chile

New Zealand3 sites

Research Site
Auckland, 2025
Research Site
Hamilton
Research Site
Palmerston North, 5301

Other trials in New Zealand

Australia1 site

Research Site
Herston, 4029

Other trials in Australia

Panama1 site

Research Site
Panama City

Other trials in Panama

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness

Read the detailed description

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Conditions: RSV Illness in ≤12 Months of Participants
Being tested: Motavizumab, Placebo
Keywords: Respiratory Syncytial Virus illness, RSV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MotavizumabBiological
Also called MEDI-524
A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.
PlaceboOther
A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Study groups in NCT00421304
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study. Receives: Other: Placebo
Motavizumab 30 mg/kg	Experimental	Participants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study. Receives: Biological: Motavizumab
Motavizumab 100 mg/kg	Experimental	Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study. Receives: Biological: Motavizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (<=12) months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 1
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 2
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 3
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 4
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 5
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 6
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 7
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 30
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 90
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Measured: Day 180
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Motavizumab concentration in nasal wash aspirates is reported.
Measured: Day 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Motavizumab concentration in nasal wash aspirates is reported.
Measured: Day 1
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Motavizumab concentration in nasal wash aspirates is reported.
Measured: Day 2
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Motavizumab concentration in nasal wash aspirates is reported.
Measured: Day 7
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Motavizumab concentration in nasal wash aspirates is reported.
Measured: Day 30

Secondary outcomes (18)

Duration of RSV Hospitalization
Duration of RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Respiratory Assessment Change Score (RACS) Derived From Baseline
The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.
Measured: Baseline (Day 0), Days 1, 2, 3, 7, and 30
Oxygen Saturation Level During RSV Hospitalization
Oxygen saturation level during RSV hospitalization is reported.
Measured: Days 0, 1, 2, 3, 7, and 30
Heart Rate During RSV Hospitalization
Heart rate during RSV hospitalization is reported.
Measured: Days 0, 1, 2, 3, 7, and 30
Respiratory Rate During RSV Hospitalization
Respiratory rate during RSV hospitalization is reported.
Measured: Days 0, 1, 2, 3, 7, and 30
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
Number of participants with supplemental oxygen use during RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of Supplemental Oxygen Use During RSV Hospitalization
Duration of supplemental oxygen use during RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants on Mechanical Ventilation During RSV Hospitalization
Number of participants on mechanical ventilation during RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of Mechanical Ventilation During RSV Hospitalization
Duration of mechanical ventilation during RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants Admitted to the Intensive Care Unit (ICU)
Number of participants admitted to ICU is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of ICU Stay During RSV Hospitalization
Duration of ICU stay during RSV hospitalization is reported.
Measured: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants With Medically-attended Wheezing Episodes
Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.
Measured: From randomization (Day 0) through Day 360 (approximately 12 months)
Serum Concentration of Motavizumab
Motavizumab concentration in serum is reported.
Measured: Days 1, 7, 90, 180, and 360
Number of Participants With Detectable Anti-motavizumab Antibodies
Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.
Measured: Days 0, 180, and 360
Change From Baseline in Serum Cytokine Levels
Measured: Baseline (Day 0, pre-dose) through Day 360
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.
Measured: Baseline (Day 0, pre-dose) through Day 180
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: From the start of study drug (Day 0) through Day 90
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Measured: From the start of study drug (Day 0) through Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 200717 Sep 2009

First posted11 Jan 2007 (estimated)
Study start10 Jan 2007
Primary completion17 Sep 2009
Study completion17 Sep 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RSV Illness in ≤12 Months of ParticipantsStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00421304
Sponsor's protocol ID: MI-CP141
Status last verified: Jul 2021
First submitted: 9 Jan 2007
Last updated: 27 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.
PubMed 24356256

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
ClinicalTrials.gov ID: NCT00421304
Acronym / sponsor ID: MI-CP141
Conditions: RSV Illness in ≤12 Months of Participants
Keywords: Respiratory Syncytial Virus illness, RSV
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 10 Jan 2007 (actual)
Primary completion: 17 Sep 2009 (actual)
Study completion: 17 Sep 2009 (actual)
First posted: 11 Jan 2007 (estimated)
Results: Posted 27 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboParticipants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.
Motavizumab 30 mg/kg	Experimental	Biological: MotavizumabParticipants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.
Motavizumab 100 mg/kg	Experimental	Biological: MotavizumabParticipants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Who may qualify

Ages: 0 to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Previously healthy
Age less or equal to 12 months at the time of randomization
Gestational age more or equal to 36 weeks
Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
Documented positive RSV test within 48 hours prior to randomization

Key exclusion criteria (13 listed)

Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
Any use of systemic or inhaled steroids within the past 30 days prior to randomization
Intubation for ventilatory support at randomization
Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency

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
MotavizumabAlso: MEDI-524A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.	Biological	Motavizumab 100 mg/kg, Motavizumab 30 mg/kg
PlaceboA single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.	Other	Placebo

Primary outcome

Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0
Time frame: Day 0
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (<=12) months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
Time frame: Day 1
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
Time frame: Day 2
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
Time frame: Day 3
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
Time frame: Day 4
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
Time frame: Day 5
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
Time frame: Day 6
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
Time frame: Day 7
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
Time frame: Day 30
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
Time frame: Day 90
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
Time frame: Day 180
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children <=12 months of age who are hospitalized with lower respiratory tract illness.
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Time frame: Day 0
Motavizumab concentration in nasal wash aspirates is reported.
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Time frame: Day 1
Motavizumab concentration in nasal wash aspirates is reported.
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Time frame: Day 2
Motavizumab concentration in nasal wash aspirates is reported.
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Time frame: Day 7
Motavizumab concentration in nasal wash aspirates is reported.
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Time frame: Day 30
Motavizumab concentration in nasal wash aspirates is reported.

18 secondary outcomes

Duration of RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Respiratory Assessment Change Score (RACS) Derived From Baseline
Time frame: Baseline (Day 0), Days 1, 2, 3, 7, and 30
Oxygen Saturation Level During RSV Hospitalization
Time frame: Days 0, 1, 2, 3, 7, and 30
Heart Rate During RSV Hospitalization
Time frame: Days 0, 1, 2, 3, 7, and 30
Respiratory Rate During RSV Hospitalization
Time frame: Days 0, 1, 2, 3, 7, and 30
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of Supplemental Oxygen Use During RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants on Mechanical Ventilation During RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of Mechanical Ventilation During RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants Admitted to the Intensive Care Unit (ICU)
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Duration of ICU Stay During RSV Hospitalization
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Number of Participants With Medically-attended Wheezing Episodes
Time frame: From randomization (Day 0) through Day 360 (approximately 12 months)
Serum Concentration of Motavizumab
Time frame: Days 1, 7, 90, 180, and 360
Number of Participants With Detectable Anti-motavizumab Antibodies
Time frame: Days 0, 180, and 360
Change From Baseline in Serum Cytokine Levels
Time frame: Baseline (Day 0, pre-dose) through Day 360
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
Time frame: Baseline (Day 0, pre-dose) through Day 180
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the start of study drug (Day 0) through Day 90
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From the start of study drug (Day 0) through Day 30

Results and safety

Results posted to the registry on 27 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	32
Motavizumab 30 mg/kg	39	35
Motavizumab 100 mg/kg	39	31

Primary outcome: Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0

Time frame: Day 0. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	Placebo n = 37	Motavizumab 30 mg/kg n = 39	Motavizumab 100 mg/kg n = 36
Value	8.13 (0.73)	8.05 (1.22)	8.15 (0.86)

Placebo vs Motavizumab 30 mg/kg: p = 0.218, Wilcoxon's rank-sum test
Placebo vs Motavizumab 100 mg/kg: p = 0.643, Wilcoxon's rank-sum test
Motavizumab 30 mg/kg vs Motavizumab 100 mg/kg: p = 0.677, Wilcoxon's rank-sum test

Population analysed: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 0 were analyzed for this outcome.

Primary outcome: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1

Time frame: Day 1. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	Placebo n = 37	Motavizumab 30 mg/kg n = 38	Motavizumab 100 mg/kg n = 36
Value	7.61 (0.86)	7.54 (1.26)	7.40 (1.26)

Placebo vs Motavizumab 30 mg/kg: p = 0.257, Wilcoxon's rank-sum test
Placebo vs Motavizumab 100 mg/kg: p = 0.726, Wilcoxon's rank-sum test
Motavizumab 30 mg/kg vs Motavizumab 100 mg/kg: p = 0.551, Wilcoxon's rank-sum test

Primary outcome: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2

Time frame: Day 2. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	Placebo n = 37	Motavizumab 30 mg/kg n = 38	Motavizumab 100 mg/kg n = 36
Value	6.95 (1.21)	6.68 (1.21)	6.59 (1.35)

Placebo vs Motavizumab 30 mg/kg: p = 0.591, Wilcoxon's rank-sum test
Placebo vs Motavizumab 100 mg/kg: p = 0.393, Wilcoxon's rank-sum test
Motavizumab 30 mg/kg vs Motavizumab 100 mg/kg: p = 0.586, Wilcoxon's rank-sum test

Primary outcome: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3

Time frame: Day 3. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	Placebo n = 34	Motavizumab 30 mg/kg n = 38	Motavizumab 100 mg/kg n = 32
Value	6.12 (1.15)	6.11 (1.26)	5.95 (1.46)

Placebo vs Motavizumab 30 mg/kg: p = 0.894, Wilcoxon's rank-sum test
Placebo vs Motavizumab 100 mg/kg: p = 0.674, Wilcoxon's rank-sum test
Motavizumab 30 mg/kg vs Motavizumab 100 mg/kg: p = 0.636, Wilcoxon's rank-sum test

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of study drug (Day 0) through Day 90. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 37 (16.2%)	30 of 37 (81.1%)	0 of 37
Motavizumab 30 mg/kg	6 of 38 (15.8%)	22 of 38 (57.9%)	0 of 38
Motavizumab 100 mg/kg	7 of 38 (18.4%)	24 of 38 (63.2%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24356256Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.

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.

M. Pamela Griffin, M.D. study director

MedImmune LLC

35 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motavizumab in people with RSV Illness in ≤12 Months of Participants, run by MedImmune LLC at 35 sites in 5 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 8 inclusion and 13 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Chile, New Zealand, Australia, Panama. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2021). 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?

Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 (time frame: Day 0). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00421304, which also lists 1 linked publication.

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 27 Aug 2021.