Influenza Virus InfectionNCT03618407
Effect of Early Antiviral Therapy on Duration of Cough in Flu Patients
An observational study of Influenza Virus Infection, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This study mainly focused on the effect of early antiviral treatment on the duration of cough in influenza patients.investigators conducted an early investigation of patients with positive influenza virus and asked whether patients used antiviral drugs in the early stages. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Influenza Virus Infection
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Dec 2019
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Flu patients who were diagnosed in our hospital from April 2018 to July 2019
Who may be able to join
- For patients with flu-free flu, cough for at least one week.
- In line with the flu etiological diagnostic criteria: According to the guidelines set by the National Health and Health Committee, the diagnosis is based on etiological screening methods or confirmed methods; ages 18 to 70 years.
- There are no influenza complications such as acute lower respiratory tract infection, tonsillitis, sinusitis, otitis media, myocarditis, etc.
- It is usually healthy and there are no chronic underlying diseases such as hypertension and diabetes.
- Treating with cough as the main symptom, the cough lasts for at least one week and the chest radiograph is normal.
- Signed informed consent.
Who cannot join
- Suspected flu patients who have not received the flu etiology test;
- There is a clear comorbid disease (combined with other sites of acute bacterial or viral infections);
- There is a clear cough caused by other reasons;
- With severe liver and kidney dysfunction;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
This study mainly focused on the effect of early antiviral treatment on the duration of cough in influenza patients.investigators conducted an early investigation of patients with positive influenza virus and asked whether patients used antiviral drugs in the early stages. According to the use of drugs, patients were divided into oral oseltamivir group, oral lotus phlegm group and other groups, and investigators will collected Inspection information and medication status,during the treatment period of patients.
Read the detailed description
Cough is a common symptom of respiratory diseases and helps to clear respiratory secretions and harmful factors, but frequent severe coughing has a serious impact on the patient's work, life and social activities. Upper respiratory tract viral infection is a common cause of coughing. Many patients have a long duration of cough after suffering from flu. Cough can last for several weeks, and most often have irritating dry cough or a small amount of white mucus sputum. This type of cough is also often referred to as "subacute cough" or "post-infection cough." The mechanisms that cause this cough have not been fully elucidated, and the effect of conventional treatment is not good, and chest imaging has no obvious abnormalities. The use of large amounts of antibiotics is ineffective or ineffective. Antihistamine H1 receptor antagonists and central antitussives are often only effective or ineffective in the short term. The effects of various bronchodilators and even hormone drugs are not clear. Due to the poor efficacy of multiple treatments, patients are repeatedly subjected to various tests, which not only increases the pain but also aggravates the economic burden.
Therefore, it is necessary to further clarify the causes and treatment measures of post-influenza cough patients.
- Conditions
- Influenza Virus Infection
- Keywords
- Influenza, Antiviral Treatment, Cough, Oseltamivir capsule, Lotus Clear Capsule
- Medical subject headings
- Influenza, Human, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral oseltamivir group | Patients with influenza virus positive and early oral oseltamivir capsules | |
| Oral Lotus Capsules group | Patients with positive influenza virus and early oral administration of lotus extract capsules | |
| other group | Influenza virus positive patients who were not treated with oral lotus capsule or oseltamivir capsules early |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough duration
Investigators will follow up every other week for follow-up calls or outpatients to ask about cough and medication, until the patient stops coughing, cough lasts from 1 day to 12 weeks, and cough time is greater than 12 weeks. Investigators should seriously exclude cough caused by other factors. No other factors are still included in the study, and the maximum time is no more than 6 months. If there are other factors causing cough, it will not be included in the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HuKe, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618407
- Sponsor's protocol ID
- HuKe
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Antiviral Therapy on Duration of Cough in Flu Patients
- ClinicalTrials.gov ID
- NCT03618407
- Acronym / sponsor ID
- HuKe
- Conditions
- Influenza Virus Infection
- Keywords
- Influenza, Antiviral Treatment, Cough, Oseltamivir capsule, Lotus Clear Capsule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Aug 2018 (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.
This study mainly focused on the effect of early antiviral treatment on the duration of cough in influenza patients.investigators conducted an early investigation of patients with positive influenza virus and asked whether patients used antiviral drugs in the early stages. According to the use of drugs, patients were divided into oral oseltamivir group, oral lotus phlegm group and other groups, and investigators will collected Inspection information and medication status,during the treatment period of patients.
Detailed description
Cough is a common symptom of respiratory diseases and helps to clear respiratory secretions and harmful factors, but frequent severe coughing has a serious impact on the patient's work, life and social activities. Upper respiratory tract viral infection is a common cause of coughing. Many patients have a long duration of cough after suffering from flu. Cough can last for several weeks, and most often have irritating dry cough or a small amount of white mucus sputum. This type of cough is also often referred to as "subacute cough" or "post-infection cough." The mechanisms that cause this cough have not been fully elucidated, and the effect of conventional treatment is not good, and chest imaging has no obvious abnormalities. The use of large amounts of antibiotics is ineffective or ineffective. Antihistamine H1 receptor antagonists and central antitussives are often only effective or ineffective in the short term. The effects of various bronchodilators and even hormone drugs are not clear. Due to the poor efficacy of multiple treatments, patients are repeatedly subjected to various tests, which not only increases the pain but also aggravates the economic burden.
Therefore, it is necessary to further clarify the causes and treatment measures of post-influenza cough patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral oseltamivir group | – | –Patients with influenza virus positive and early oral oseltamivir capsules |
| Oral Lotus Capsules group | – | –Patients with positive influenza virus and early oral administration of lotus extract capsules |
| other group | – | –Influenza virus positive patients who were not treated with oral lotus capsule or oseltamivir capsules early |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Flu patients who were diagnosed in our hospital from April 2018 to July 2019
Key inclusion criteria (6 listed)
- For patients with flu-free flu, cough for at least one week.
- In line with the flu etiological diagnostic criteria: According to the guidelines set by the National Health and Health Committee, the diagnosis is based on etiological screening methods or confirmed methods; ages 18 to 70 years.
- There are no influenza complications such as acute lower respiratory tract infection, tonsillitis, sinusitis, otitis media, myocarditis, etc.
- It is usually healthy and there are no chronic underlying diseases such as hypertension and diabetes.
- Treating with cough as the main symptom, the cough lasts for at least one week and the chest radiograph is normal.
Key exclusion criteria (5 listed)
- Suspected flu patients who have not received the flu etiology test;
- There is a clear comorbid disease (combined with other sites of acute bacterial or viral infections);
- There is a clear cough caused by other reasons;
- With severe liver and kidney dysfunction;
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cough duration
Time frame: 6 months
Investigators will follow up every other week for follow-up calls or outpatients to ask about cough and medication, until the patient stops coughing, cough lasts from 1 day to 12 weeks, and cough time is greater than 12 weeks. Investigators should seriously exclude cough caused by other factors. No other factors are still included in the study, and the maximum time is no more than 6 months. If there are other factors causing cough, it will not be included in the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Virus Infection, run by Renmin Hospital of Wuhan University at 1 site 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. 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 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.
Are results available for this study?
Results are not available in the source record.
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?
Cough duration (time frame: 6 months). 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 7 Aug 2018.