Respiratory Syncytial Virus InfectionsPhase 1NCT01230645
RV568 - Viral Challenge With RSV
A Phase 1 study testing RV568 in people with Respiratory Syncytial Virus Infections, run by Respivert Ltd at 1 site in United Kingdom.
Trial summary
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is effective in reducing the inflammation caused by viral infections such as RSV (respiratory syncytial virus). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RV568
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects aged 18 - 45 years
- agreeable to use adequate contraception throughout the study
- negative hepatitis B, hepatitis C and HIV screen
- negative drugs of abuse, alcohol and nicotine screen
- able to provide written informed consent and be willing to comply with the study restrictions and requirements
- low titres of RSV neutralising antibody measured during screening
Who cannot join
- acute or chronic illness or clinically relevant abnormality noted at the screening visit
- presence of febrile illness or symptoms of upper or lower respiratory tract infection in the 28 days prior to viral inoculation
- history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition
- diabetes
- history or evidence of autoimmune disease or known impaired immune responsiveness
- recent (within the last 3 years) and/or recurrent history of autonomic dysfunction
Show all 31Show fewer
- anatomic or neurological abnormality impairing the gag reflex or associated with an increased risk of aspiration, any abnormality significantly altering the anatomy of the nose or nasopharynx. Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome. Any nasal or sinus surgery within 4 months prior to virus administration.
- history of smoking in the past 6 months
- positive test for drugs or alcohol at screening
- inadequate venous access
- abnormal pulmonary function at screening
- abnormal laboratory or ECG at screening
- acute or chronic use of medication to treat nasal congestion
- use of any prescription drugs, herbal supplements, within 4 weeks prior to virus challenge, and/or over-the-counter medication, dietary supplements within 2 weeks prior to virus challenge
- treatment with systemic glucocorticoids, antiviral drugs, immunoglobulins or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to dosing. Receipt of any systemic chemotherapy agent at any time
- treatment with any investigational drug within 3 months, or prior participation in a clinical trial of any RSV IMP, medication or experimental RSV viral challenge delivered directly to the respiratory tract within 1 year prior to dosing, or receipt of more than 4 investigational drug within 12 months
- history of multiple and recurring allergies and/or adverse reaction to any components of the challenge virus preparation
- allergy to gentamicin
- significant history of seasonal hay fever or seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or chronic nasal or sinus condition
- intention to travel between first and last visit (to countries for which vaccinations are recommended or where high risk of infection exists)
- healthcare workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge
- household member or close contact (for an additional 2 weeks after discharge from the isolation facility) who is:
- less than 3 years of age;
- any person with any known immunodeficiency;
- any person receiving immunosuppressant medications;
- any person undergoing or soon to undergo cancer chemotherapy within 28 days of viral challenge;
- any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition including but not exclusive to the conditions listed below; or
- any person who has received a transplant (bone marrow or solid organ)
- employees or relatives of Retroscreen Virology or RespiVert Ltd
- other finding in the medical interview, physical exam, or screening investigations that, in the opinion of the Investigator, deem the subject unsuitable for the study
- subjects who in the opinion of their general practitioner or the Investigator, should not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Intranasal RV568 (400μg) Administered Twice Daily to Adult Male Volunteers Experimentally Inoculated With Live Respiratory Syncytial Virus
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is effective in reducing the inflammation caused by viral infections such as RSV (respiratory syncytial virus).
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RV568, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV568Drug
RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
PlaceboDrug
Placebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
| Study group | Role | What they receive |
|---|---|---|
| RV568 treatment group | Experimental | Not described Receives: Drug: RV568 |
| Placebo treatment group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL8 induction in nasal wash samples
Measured: 16 day quarantine period
Secondary outcomes (7)
RSV viral load
Measured: 16 day quarantine period
Changes in symptoms of RSV infection
Measured: 16 day quarantine period
Assessment of mucus weight and tissue counts
Measured: 16 day quarantine period
Viable nasal cell counts in nasal washes
Measured: 16 day quarantine period
Frequency of RSV infection
Measured: 16 day quarantine period
Plasma RV568 levels
Measured: 16 day quarantine period
Assessment of IL6 in nasal wash samples
Measured: 16 day quarantine period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anthony Gilbert, MD, Principal investigator, Retroscreen Virology Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230645
- Sponsor's protocol ID
- RVH003
- Other IDs
- 2010-021527-26
- Status last verified
- Feb 2011
- First submitted
- 27 Oct 2010
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Intranasal RV568 (400μg) Administered Twice Daily to Adult Male Volunteers Experimentally Inoculated With Live Respiratory Syncytial Virus
- ClinicalTrials.gov ID
- NCT01230645
- Acronym / sponsor ID
- RVH003
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 is effective in reducing the inflammation caused by viral infections such as RSV (respiratory syncytial virus).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV568 treatment group | Experimental | Drug: RV568 |
| Placebo treatment group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy male subjects aged 18 - 45 years
- agreeable to use adequate contraception throughout the study
- negative hepatitis B, hepatitis C and HIV screen
- negative drugs of abuse, alcohol and nicotine screen
- able to provide written informed consent and be willing to comply with the study restrictions and requirements
Key exclusion criteria (31 listed)
- acute or chronic illness or clinically relevant abnormality noted at the screening visit
- presence of febrile illness or symptoms of upper or lower respiratory tract infection in the 28 days prior to viral inoculation
- history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition
- diabetes
- history or evidence of autoimmune disease or known impaired immune responsiveness
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 |
|---|---|---|
| RV568RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8) | Drug | RV568 treatment group |
| PlaceboPlacebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8) | Drug | Placebo treatment group |
Primary outcome
IL8 induction in nasal wash samples
Time frame: 16 day quarantine period
7 secondary outcomes
RSV viral load
Time frame: 16 day quarantine period
Changes in symptoms of RSV infection
Time frame: 16 day quarantine period
Assessment of mucus weight and tissue counts
Time frame: 16 day quarantine period
Viable nasal cell counts in nasal washes
Time frame: 16 day quarantine period
Frequency of RSV infection
Time frame: 16 day quarantine period
Plasma RV568 levels
Time frame: 16 day quarantine period
Assessment of IL6 in nasal wash samples
Time frame: 16 day quarantine period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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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.
Anthony Gilbert, MD principal investigator
Retroscreen Virology Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RV568 in people with Respiratory Syncytial Virus Infections, run by Respivert Ltd at 1 site in United Kingdom.
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 6 inclusion and 31 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IL8 induction in nasal wash samples (time frame: 16 day quarantine period). 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 11 Feb 2011.