RSV InfectionPhase 2REVIRAL2NCT04267822
Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV
A Phase 2 study testing RV521 oral tablet in people with RSV Infection and Stem Cell Transplant Complications, run by Pfizer.
Trial summary
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- RSV Infection, Stem Cell Transplant Complications, Lower Resp Tract Infection
- What is being tested?
- RV521 oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2020to 31 Jul 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has undergone autologous or allogeneic HCT using any conditioning regimen within 1 year of randomization. Subjects who have undergone HCT more than 1 year before Randomization are eligible if all other inclusion/exclusion criteria are satisfied and under at least one of the following conditions:
- Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or
- Has used systemic corticosteroids in the 30 days prior to RSV infection
- Has moderate to severe immunocompromise, defined as a score ≥ 5 on the ISI-RSV and/or an ALC of ≤ 500 cells/ mm3
- Documentation of positive RSV infection in the upper airway
Who cannot join
- Use of non-marketed investigational agents within 30 days, OR use of an investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT.
- Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor of CYP3A4, within 2 weeks of Randomization.
- Receiving a prescription, OTC, or herbal medication that is a substrate of CYP3A4 with a narrow therapeutic index where monitoring blood levels is not possible.
- Known chronic infection with hepatitis B, C, or HIV.
- Is in the pre-engraftment period during RSV infection.
- Admitted to the hospital primarily for lower respiratory tract disease of any cause as determined by the Investigator.
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- Any condition requiring mechanical ventilation or vasopressor support at the time of randomization.
- Clinically significant bacteremia or fungemia within 5 days prior to Screening that has not been adequately treated.
- Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated.
- Excessive nausea/vomiting at Screening or an inability to swallow capsules.
- Elevation of hepatic enzymes or renal compromise.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Eligible subjects are adults with a documented symptomatic RSV infection who have undergone HCT transplantation and are moderately to severely immunocompromised. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 or placebo, twice daily for 10 days.
Read the detailed description
The purpose of this study is to compare the viral load, safety, tolerability, and clinical efficacy of RV521 compared to placebo. This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study. Up to 200 adult subjects with a documented symptomatic RSV URTI who have undergone HCT within 1 year of randomization and who are moderately to severely immunocompromised will be randomized.
Qualified subjects will be randomized in a 1:1 ratio to receive RV521 capsules or matching placebo twice daily for 10 days. After the completion of the 10-day double-blind treatment period, subjects will be followed for an additional 28 days. Study drug may be taken on an outpatient or inpatient basis, depending on clinical status and site practices. Randomization will be stratified by type of HCT graft and ALC count. There are 9 clinic visits planned for this study.
- Being tested
- RV521 oral tablet, Placebo oral tablet
- Keywords
- RV521, lower respiratory tract complication, HCT, hematopoietic cell transplantation, LRTI, Respiratory tract infection, immunocompromise
- Medical subject headings
- Respiratory Syncytial Virus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV521 oral tabletDrug
Also called sisunatovir
Each RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)
Placebo oral tabletDrug
Also called vehicle
Each placebo dose is four capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)
| Study group | Role | What they receive |
|---|---|---|
| RV521 Capsules | Experimental | RV521 is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. They are a white, opaque capsule and administered orally. Receives: Drug: RV521 oral tablet |
| RV521 Placebo Capsules | Placebo comparator | RV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study
Progression to LRTC during the study defined as one of the following:
- Primary LRTI caused by RSV
- Secondary bacterial LRTI
- LRTI caused by another pathogen
- LRTC of unknown etiology
Measured: Pre-dose baseline (Day 1) through Visit 8 (Day 28)
Change in RSV nasal viral load (via RT-qPCR)
RSV change measured by the time-weighted average (DAVG) viral load using RT qPCR
Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Secondary outcomes (24)
Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs
Safety analyses will include a summary of AEs, including but not limited to n (%) of subjects in each treatment group and overall.
Measured: First dose of study drug through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters)
BP will be collected in mm Hg. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Measured: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)
Body Temperature will be collected in degrees Fahrenheit (°F) or degrees Celsius (°C). Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Measured: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)
Respiration rate will be measured in breaths per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Measured: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)
Heart rate will be measured in beats per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.
Measured: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI
Weight and height will be collected and combined to report BMI
Measured: Baseline through Visit 8 (Day 28)
Evaluate the proportion of subjects with changes and shifts in hematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline.
Results at each visit will be summarized using the statistics n, mean, standard deviation, median, minimum and maximum. Also, change from baseline will also be summarized by post baseline visits.
Measured: Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28
Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline
ECGs will be taken with a centrally supplied ECG machine and electronically transmitted to a central ECG repository. ECG will only be evaluated by the Investigator for normal, abnormal NCS and abnormal CS.
Parameters collected will be:
- Ventricular Heart Rate (bpm)
- PR Interval (msec)
- QRS Interval (msec)
- QT Interval (msec)
- QTcB Interval (msec)
Results at each visit will be summarized using the statistics: n (number of observations), mean, SD, median, minimum and maximum.
Measured: Measurements will be taken at Day 1/Visit 2 (pre-dose and at 5-hours post-dose), on Day 3/Visit 4 (at 5 hours post-dose), and at Visit 6 (Day 14)
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR
Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by RT-qPCR.
Measured: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA
Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by CBIA.
Measured: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Mean change in RSV viral load assessed via CBIA
change measured by the time weighted average (DAVG) viral load using CBIA
Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Mean change from baseline in viral RNA shedding
RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.
Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA at each timepoint
RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.
Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Time to improvement in RSV-related symptoms
Defined as all symptoms present at initiation of therapy are mild or no longer present. (absent/resolved)
Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)
Time to total resolution of all RSV-related symptoms
Defined as all symptoms are no longer present.
Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)
Proportion of days with lowest daily SpO2 ≥ 90% on room air
SpO2 measured at every visit. For subjects on oxygen or who are mechanically ventilated may have this waived.
Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)
Number of days where supplementary oxygen was required
Use of daily supplementary oxygen will be collected throughout the study.
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects who require hospitalization during the study
Daily hospitalization utilization will be collected
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Mean number of days of hospitalization during the study
Daily hospitalization utilization will be collected
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects requiring ICU
Daily ICU utilization will be collected
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Mean number of days in ICU
Daily ICU utilization will be collected
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects requiring mechanical ventilation
Daily mechanical ventilation requirements will be collected
Measured: Baseline (Day 1) through Visit 8 (Day 28)
Number of subjects who experience death (all-cause mortality)
Patient outcome will be followed and collected
Measured: First dose of study drug through Visit 8 (Day 28)
Number of subjects who experience death attributable to LRTC
Patient outcome will be followed and collected
Measured: First dose of study drug through Visit 8 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start15 Jun 2020 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Model description
- A Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PfizerCT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267822
- Sponsor's protocol ID
- REVC006
- Other IDs
- C5241011
- Acronym
- REVIRAL2
- Status last verified
- May 2023
- First submitted
- 5 Feb 2020
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)
- ClinicalTrials.gov ID
- NCT04267822
- Acronym / sponsor ID
- REVIRAL2 / REVC006
- Keywords
- RV521, lower respiratory tract complication, HCT, hematopoietic cell transplantation, LRTI, Respiratory tract infection, immunocompromise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- 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.
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Eligible subjects are adults with a documented symptomatic RSV infection who have undergone HCT transplantation and are moderately to severely immunocompromised. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 or placebo, twice daily for 10 days.
Detailed description
The purpose of this study is to compare the viral load, safety, tolerability, and clinical efficacy of RV521 compared to placebo. This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study. Up to 200 adult subjects with a documented symptomatic RSV URTI who have undergone HCT within 1 year of randomization and who are moderately to severely immunocompromised will be randomized.
Qualified subjects will be randomized in a 1:1 ratio to receive RV521 capsules or matching placebo twice daily for 10 days. After the completion of the 10-day double-blind treatment period, subjects will be followed for an additional 28 days. Study drug may be taken on an outpatient or inpatient basis, depending on clinical status and site practices. Randomization will be stratified by type of HCT graft and ALC count. There are 9 clinic visits planned for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| RV521 Capsules | Experimental | Drug: RV521 oral tabletRV521 is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. They are a white, opaque capsule and administered orally. |
| RV521 Placebo Capsules | Placebo comparator | Drug: Placebo oral tabletRV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has undergone autologous or allogeneic HCT using any conditioning regimen within 1 year of randomization. Subjects who have undergone HCT more than 1 year before Randomization are eligible if all other inclusion/exclusion criteria are satisfied and under at least one of the following conditions:
- Has moderate to severe immunocompromise, defined as a score ≥ 5 on the ISI-RSV and/or an ALC of ≤ 500 cells/ mm3
- Documentation of positive RSV infection in the upper airway
Key exclusion criteria (11 listed)
- Use of non-marketed investigational agents within 30 days, OR use of an investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT.
- Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor of CYP3A4, within 2 weeks of Randomization.
- Receiving a prescription, OTC, or herbal medication that is a substrate of CYP3A4 with a narrow therapeutic index where monitoring blood levels is not possible.
- Known chronic infection with hepatitis B, C, or HIV.
- Is in the pre-engraftment period during RSV infection.
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 |
|---|---|---|
| RV521 oral tabletAlso: sisunatovirEach RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total) | Drug | RV521 Capsules |
| Placebo oral tabletAlso: vehicleEach placebo dose is four capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total) | Drug | RV521 Placebo Capsules |
Primary outcome
Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study
Time frame: Pre-dose baseline (Day 1) through Visit 8 (Day 28)
Progression to LRTC during the study defined as one of the following: * Primary LRTI caused by RSV * Secondary bacterial LRTI * LRTI caused by another pathogen * LRTC of unknown etiology
Change in RSV nasal viral load (via RT-qPCR)
Time frame: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
RSV change measured by the time-weighted average (DAVG) viral load using RT qPCR
24 secondary outcomes
Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs
Time frame: First dose of study drug through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters)
Time frame: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)
Time frame: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)
Time frame: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)
Time frame: Baseline through Visit 8 (Day 28)
Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI
Time frame: Baseline through Visit 8 (Day 28)
Evaluate the proportion of subjects with changes and shifts in hematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline.
Time frame: Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28
Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline
Time frame: Measurements will be taken at Day 1/Visit 2 (pre-dose and at 5-hours post-dose), on Day 3/Visit 4 (at 5 hours post-dose), and at Visit 6 (Day 14)
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR
Time frame: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA
Time frame: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)
Mean change in RSV viral load assessed via CBIA
Time frame: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Mean change from baseline in viral RNA shedding
Time frame: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA at each timepoint
Time frame: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)
Time to improvement in RSV-related symptoms
Time frame: Daily from baseline (Day 1) through Visit 8 (Day 28)
Time to total resolution of all RSV-related symptoms
Time frame: Daily from baseline (Day 1) through Visit 8 (Day 28)
Proportion of days with lowest daily SpO2 ≥ 90% on room air
Time frame: Daily from baseline (Day 1) through Visit 8 (Day 28)
Number of days where supplementary oxygen was required
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects who require hospitalization during the study
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Mean number of days of hospitalization during the study
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects requiring ICU
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Mean number of days in ICU
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Proportion of subjects requiring mechanical ventilation
Time frame: Baseline (Day 1) through Visit 8 (Day 28)
Number of subjects who experience death (all-cause mortality)
Time frame: First dose of study drug through Visit 8 (Day 28)
Number of subjects who experience death attributable to LRTC
Time frame: First dose of study drug through Visit 8 (Day 28)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
PfizerCT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RV521 oral tablet in people with RSV Infection and Stem Cell Transplant Complications, run by Pfizer.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study (time frame: Pre-dose baseline (Day 1) through Visit 8 (Day 28)). The study lists 2 primary outcomes in all. 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 8 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.