Respiratory Syncytial Virus InfectionPhase 2NCT06206720
A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
A Phase 2 study testing Deuremidevir Hydrobromide for Suspension in people with Respiratory Syncytial Virus Infection, run by Vigonvita Life Sciences at 22 sites in China.
Trial summary
To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- Deuremidevir Hydrobromide for Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 22 sitesChina
- Study dates
- 31 Jan 2024to 16 Jun 2025
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female infants ≥1 month and ≤24 months；
- Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
- Onset of RSV infection symptoms should be ≤ 5 days；
- Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
- Patient must have a Wang Respiratory Score ≥ 5;
- Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;
- The parent/legal guardian must have provided written informed consent for the patient to participate.
Who cannot join
- Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;
- Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
- Requires vasopressors or inotropic support at the time of enrollment;
- Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
- Patients with hypercapnia (Except for patients who have recovered at the time of screening);
- Chronic or persistent feeding difficulties;
Show all 19Show fewer
- Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;
- Symptomatic because of inborn errors of metabolism;
- Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;
- Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).
- Clinical evidence of hepatic decompensation
- Renal failure including renal anomalies likely to be associated with renal insufficiency;
- Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months);
- Suspected or known to have congenital acquired immunodeficiency;
- A history of epilepsy or seizures;
- A history of high allergies;
- Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;
- Participation in an investigational drug or device study within 30 days prior to the date of screening;
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
The first Affiliated hospital of Bengbu Medical University
Bengbu, Anhui
Changde First people's Hospital
Changde, Hunan
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan
Chongqing University Jiangjin Hospital
Chongqing, Chongqing Municipality
Guangdong Women and Children's Hospital and Health Institute
Guangzhou, Guangdong
Panyu Maternal and Child care Service centre of Guangzhou
Guangzhou, Guangdong
Hainan women and children's Medical centre
Haikou, Hainan
Shulan (hangzhou) Hosipital
Hangzhou, Zhejiang, 310022
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hangzhou First people's Hospital
Hangzhou, Zhejiang
Liaocheng People's Hospital
Liaocheng, Shandong
Linfen Central Hospital
Linfen, Shanxi, 041000
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Mianyang Central Hospital
Mianyang, Sichuan
Jiangxi Maternal and Child Health
Nanchang, Jiangxi
Sanmenxia Central Hospital
Sanmenxia, Henan
The Sceond Affiliated hospital of Shantou University Medical college
Shantou, Guangdong
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Shenzhen Guangming District People's Hospital
Shenzhen, Guangdong, 518106
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215003
Xiamen Children's Hospital
Xiamen, Fujian, 361006
Xiamen Maternity and Child Healthcare Hospital
Xiamen, Fujian
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.
To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.
Read the detailed description
This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.
It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- Deuremidevir Hydrobromide for Suspension, 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.
Deuremidevir Hydrobromide for SuspensionDrug
Also called VV116
15 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times.
20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times.
20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times.
PlaceboDrug
Also called VV116 placebo
15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times.
20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times.
20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times.
| Study group | Role | What they receive |
|---|---|---|
| Deuremidevir Hydrobromide for Suspension | Experimental | Deuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients. Receives: Drug: Deuremidevir Hydrobromide for Suspension |
| Placebo | Experimental | Placebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events during the study
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: From baseline through study completion, up to Day 26
Subject withdrawals due to Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: From baseline through study completion, up to Day 26
Time to resolution of 6 clinical symptoms related to RSV infection
Time to resolution of 6 clinical symptoms related to RSV infection
Measured: From baseline through study completion, up to Day 14
Time to resolution of individual clinical symptoms related to RSV infection
Time to resolution of individual clinical symptoms related to RSV infection
Measured: From baseline through study completion, up to Day 14
Differences of the proportion of subjects with wheezing remission
Differences of the proportion of subjects with wheezing remission
Measured: From baseline up to Day2-7 and Day14
Differences of the proportion of subjects with wheezing resolution
Differences of the proportion of subjects with wheezing resolution
Measured: From baseline up to Day2-7 and Day14
Difference of the proportion of subjects with cough remission
Difference of the proportion of subjects with cough remission
Measured: From baseline up to Day2-7 and Day14
Difference of the proportion of subjects with cough resolution
Difference of the proportion of subjects with cough resolution
Measured: From baseline up to Day2-7、Day14 and D26
Changes of bronchiolitis score
The differences of change in the bronchiolitis score are to be evaluated between the Deuterium Hydrobromide for suspension and placebo arms after treatment. The total score is reported with a range from 0 to 12. The minimum and maximum values of 0 and 3 separately are defined for each scoring item. A decreasing value of the total score represents a clinical improvement. Subscales are not applicable in this scoring system.
Measured: From baseline up to Day2-7 and Day14
Proportions of subjects achieving symptom remission &disease remission
Symptom remission was defined as bronchiolitis score ≤1. Disease remission was defined as bronchiolitis score ≤1 and with no assisted ventilation.
Measured: From baseline up to Day2-7 and Day14
Time from first treatment to symptom remission &disease remission
The time difference from the first treatment to the time subjects achieved symptom remission between the Deuterium Hydrobromide for suspension and placebo arms.
The time difference from the first treatment to the time subjects achieved disease remission between the Deuterium Hydrobromide for suspension and placebo arms.
Measured: From first treatment through study completion, up to Day 14
Differences of frequency of Intensive Care Unit (ICU) admission
The differences of frequency of ICU admission between Deuterium Hydrobromide for suspension and placebo arms.
Measured: From first treatment through study completion, up to Day 14
Differences of length of ICU stay
The differences of length of ICU stay between Deuterium Hydrobromide for suspension and placebo arms.
Measured: From first treatment through study completion, up to Day 14
Differences of frequency of assisting ventilation
The frequency difference from the first treatment to the end of assisting ventilation therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.
Measured: From first treatment through study completion, up to Day 14
Differences in the duration of receiving oxygen therapy
The duration difference from the first treatment to the end of receiving oxygen therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.
Measured: From first treatment through study completion, up to Day 14
Changes of viral load
The antiviral effects in infants hospitalized with RSV are to be determined by measuring the differences in viral load determined by RT-PCR between the Deuterium Hydrobromide for suspension and placebo arms after treatment.
Measured: From baseline up to Day2-7 and Day14
Changes of area under curve of viral load
The antiviral effects are to be determined by measuring the differences in area under curve (AUC).
Measured: From baseline up to Day2-7 and Day14
Apparent total body clearance (CL/F)
Apparent clearance of of 116-N1.
Measured: From baseline up to Day2-7
Area under the plasma concentration time curve from time zero to the last(AUC0-t)
Area under the plasma concentration time curve from time zero to the last of 116-N1.
Measured: From baseline up to Day2-7
apparent volume of distribution(V)
Apparent volume of distribution during the terminal phase of 116-N1.
Measured: From baseline up to Day2-7
Secondary outcomes (7)
The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection
Check if there is a positive correlation between viral load and the resolution time of 6 clinical signs
Measured: From baseline up to Day2-7 and Day14
The correlation between viral load and bronchiolitis score
Check if there is a positive correlation between changes in viral load and changes in bronchiolitis score.
Measured: From baseline up to Day2-7and Day14
The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects
The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects.
Measured: From baseline up to Day2-7 and Day14
The difference in length of hospital stay
The difference in length of hospital stay between the experimental drug group and the placebo group due to RSV infection related diseases.
Measured: From baseline up to Day2-7 and Day14
Proportions of subjects with viral load below LLOQ
The proportion of subjects whose viral load values are below LLOQ (lower limit of quantitation) after treatment.
Measured: From baseline up to Day2-7 and Day14
The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs
The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs
Measured: From baseline up to Day2-7 and Day14
The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and bronchiolitis score and RSV viral load (VL) in respiratory sample
The correlation between AUC0-t（ Area under the plasma concentration time curve from time zero to the last） and bronchiolitis score and RSV viral load (VL) in respiratory sample.
Measured: From baseline up to Day2-7 and Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start31 Jan 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- lanjuan li, Principal investigator, Shulan (Hangzhou) HospitalZhen Qin, Principal investigator, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206720
- Sponsor's protocol ID
- VV116-RSV-II/III-01
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.
- ClinicalTrials.gov ID
- NCT06206720
- Acronym / sponsor ID
- VV116-RSV-II/III-01
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 16 Jan 2024 (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.
To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.
Detailed description
This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.
It is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deuremidevir Hydrobromide for Suspension | Experimental | Drug: Deuremidevir Hydrobromide for SuspensionDeuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients. |
| Placebo | Experimental | Drug: PlaceboPlacebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male or female infants ≥1 month and ≤24 months；
- Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
- Onset of RSV infection symptoms should be ≤ 5 days；
- Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
- Patient must have a Wang Respiratory Score ≥ 5;
Key exclusion criteria (19 listed)
- Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;
- Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
- Requires vasopressors or inotropic support at the time of enrollment;
- Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
- Patients with hypercapnia (Except for patients who have recovered at the time of screening);
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 |
|---|---|---|
| Deuremidevir Hydrobromide for SuspensionAlso: VV11615 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times. 20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times. | Drug | Deuremidevir Hydrobromide for Suspension |
| PlaceboAlso: VV116 placebo15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times. 20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events during the study
Time frame: From baseline through study completion, up to Day 26
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Subject withdrawals due to Adverse Events
Time frame: From baseline through study completion, up to Day 26
An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time to resolution of 6 clinical symptoms related to RSV infection
Time frame: From baseline through study completion, up to Day 14
Time to resolution of 6 clinical symptoms related to RSV infection
Time to resolution of individual clinical symptoms related to RSV infection
Time frame: From baseline through study completion, up to Day 14
Time to resolution of individual clinical symptoms related to RSV infection
Differences of the proportion of subjects with wheezing remission
Time frame: From baseline up to Day2-7 and Day14
Differences of the proportion of subjects with wheezing remission
Differences of the proportion of subjects with wheezing resolution
Time frame: From baseline up to Day2-7 and Day14
Differences of the proportion of subjects with wheezing resolution
Difference of the proportion of subjects with cough remission
Time frame: From baseline up to Day2-7 and Day14
Difference of the proportion of subjects with cough remission
Difference of the proportion of subjects with cough resolution
Time frame: From baseline up to Day2-7、Day14 and D26
Difference of the proportion of subjects with cough resolution
Changes of bronchiolitis score
Time frame: From baseline up to Day2-7 and Day14
The differences of change in the bronchiolitis score are to be evaluated between the Deuterium Hydrobromide for suspension and placebo arms after treatment. The total score is reported with a range from 0 to 12. The minimum and maximum values of 0 and 3 separately are defined for each scoring item. A decreasing value of the total score represents a clinical improvement. Subscales are not applicable in this scoring system.
Proportions of subjects achieving symptom remission &disease remission
Time frame: From baseline up to Day2-7 and Day14
Symptom remission was defined as bronchiolitis score ≤1. Disease remission was defined as bronchiolitis score ≤1 and with no assisted ventilation.
Time from first treatment to symptom remission &disease remission
Time frame: From first treatment through study completion, up to Day 14
The time difference from the first treatment to the time subjects achieved symptom remission between the Deuterium Hydrobromide for suspension and placebo arms. The time difference from the first treatment to the time subjects achieved disease remission between the Deuterium Hydrobromide for suspension and placebo arms.
Differences of frequency of Intensive Care Unit (ICU) admission
Time frame: From first treatment through study completion, up to Day 14
The differences of frequency of ICU admission between Deuterium Hydrobromide for suspension and placebo arms.
Differences of length of ICU stay
Time frame: From first treatment through study completion, up to Day 14
The differences of length of ICU stay between Deuterium Hydrobromide for suspension and placebo arms.
Differences of frequency of assisting ventilation
Time frame: From first treatment through study completion, up to Day 14
The frequency difference from the first treatment to the end of assisting ventilation therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.
Differences in the duration of receiving oxygen therapy
Time frame: From first treatment through study completion, up to Day 14
The duration difference from the first treatment to the end of receiving oxygen therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.
Changes of viral load
Time frame: From baseline up to Day2-7 and Day14
The antiviral effects in infants hospitalized with RSV are to be determined by measuring the differences in viral load determined by RT-PCR between the Deuterium Hydrobromide for suspension and placebo arms after treatment.
Changes of area under curve of viral load
Time frame: From baseline up to Day2-7 and Day14
The antiviral effects are to be determined by measuring the differences in area under curve (AUC).
Apparent total body clearance (CL/F)
Time frame: From baseline up to Day2-7
Apparent clearance of of 116-N1.
Area under the plasma concentration time curve from time zero to the last(AUC0-t)
Time frame: From baseline up to Day2-7
Area under the plasma concentration time curve from time zero to the last of 116-N1.
apparent volume of distribution(V)
Time frame: From baseline up to Day2-7
Apparent volume of distribution during the terminal phase of 116-N1.
7 secondary outcomes
The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection
Time frame: From baseline up to Day2-7 and Day14
The correlation between viral load and bronchiolitis score
Time frame: From baseline up to Day2-7and Day14
The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects
Time frame: From baseline up to Day2-7 and Day14
The difference in length of hospital stay
Time frame: From baseline up to Day2-7 and Day14
Proportions of subjects with viral load below LLOQ
Time frame: From baseline up to Day2-7 and Day14
The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs
Time frame: From baseline up to Day2-7 and Day14
The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and bronchiolitis score and RSV viral load (VL) in respiratory sample
Time frame: From baseline up to Day2-7 and Day14
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 23 Jul 2025.
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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.
lanjuan li principal investigator
Shulan (Hangzhou) Hospital
Zhen Qin principal investigator
Shulan (Hangzhou) Hospital
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deuremidevir Hydrobromide for Suspension in people with Respiratory Syncytial Virus Infection, run by Vigonvita Life Sciences at 22 sites in China.
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 7 inclusion and 19 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. 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. 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 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?
Incidence of Adverse Events during the study (time frame: From baseline through study completion, up to Day 26). The study lists 20 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 23 Jul 2025.