CoronavirusPhase 4NCT05625035
Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection
A Phase 4 study testing Lianhua Qingwen capsules in people with Coronavirus and Traditional Chinese Medicine, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The patients with coronavirus infection usually have fever, respiratory symptoms, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, Traditional Chinese Medicine
- What is being tested?
- Lianhua Qingwen capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed SARS-CoV-2 Infection by virus testing;
- ≥18 years of age;
- informed consent provided.
Who cannot join
- overt bacterial infection in the respiratory tract resulting from common pathologies, including primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
- asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g., purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and further respiratory tract pathologies potentially affecting the trial's data analysis;
- common pulmonary diseases (e.g., severe pulmonary interstitial lesions and bronchiectasis) confirmed by chest CT;
- severe pneumonia requiring ventilator use;
- previous or present diseases potentially affecting trial participation or influencing study outcome, based on the investigator's judgment;
- pregnancy or lactation in women;
- participation in a clinical study in the past 3 months;
- history of allergy to ≥2 drugs or foods or known allergy to the drug's constituents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
International Convention and Exhibition Center Shelter Hospital
Ürümqi, Xinjiang, 831400
Panpan Hao, MD, 86-18560086593, panda.how@sdu.edu.cn
About this study
Official title: Efficacy and Safety of Lianhua Qingwen in the Long-Term Rehabilitation of Patients With Coronavirus Infection: a Randomized, Open-Label, Comparative Study
The patients with coronavirus infection usually have fever, respiratory symptoms, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with coronavirus infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingwen capsules in patients with coronavirus infection. The duration of viral shedding and symptoms before discharge, as well as the negative conversion ratio and disappearance ratio of main symptoms after 7-day treatment, will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingwen on all infection events and the long-term rehabilitation of the symptoms induced by coronavirus infection.
- Conditions
- Coronavirus, Traditional Chinese Medicine
- Being tested
- Lianhua Qingwen capsules
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lianhua Qingwen capsulesDrug
Lianhua Qingwen capsules: 4 capsules once, three times daily
| Study group | Role | What they receive |
|---|---|---|
| Lianhua Qingwen plus conventional therapy | Experimental | Not described Receives: Drug: Lianhua Qingwen capsules |
| Conventional therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all Infection events
Recurrence coronavirus infection or any new infection events
Measured: From discharge to 6 months
Secondary outcomes (68)
Duration of viral shedding
Measured: 6 months
Negative conversion ratio
Measured: 7 days
Positive conversion ratio
Measured: From discharge to 6 months
Duration of main symptoms before discharge
Measured: 6 months
Disappearance ratio of main symptoms
Measured: 7 days
Recurrence frequency of main clinical symptoms
Measured: From discharge to 6 months
Mean duration of main clinical symptoms
Measured: From discharge to 6 months
Heart rate
Measured: 6 months
Heart rate
Measured: 7 days
Heart rate
Measured: Baseline
Blood pressure
both systolic and diastolic blood pressure
Measured: 6 months
Blood pressure
both systolic and diastolic blood pressure
Measured: 7 days
Blood pressure
both systolic and diastolic blood pressure
Measured: Baseline
Infection events except SARS-CoV-2
Measured: From discharge to 6 months
Frequency of fever
Measured: From discharge to 6 months
Mean duration of fever
Measured: From discharge to 6 months
Duration of fever before discharge
Measured: 6 months
Disappearance ratio of fever
Measured: 7 days
Frequency of respiratory symptoms
Measured: From discharge to 6 months
Mean duration of respiratory symptoms
Measured: From discharge to 6 months
Duration of respiratory symptoms before discharge
Measured: 6 months
Disappearance ratio of respiratory symptoms
Measured: 7 days
Frequency of nasal congestion or runny nose
Measured: From discharge to 6 months
Mean duration of nasal congestion or runny nose
Measured: From discharge to 6 months
Duration of nasal congestion or runny nose before discharge
Measured: 6 months
Disappearance ratio of nasal congestion or runny nose
Measured: 7 days
Frequency of chest distress
Measured: From discharge to 6 months
Mean duration of chest distress
Measured: From discharge to 6 months
Duration of chest distress before discharge
Measured: 6 months
Disappearance ratio of chest distress
Measured: 7 days
Frequency of palpitations
Measured: From discharge to 6 months
Mean duration of palpitations
Measured: From discharge to 6 months
Duration of palpitations before discharge
Measured: 6 months
Disappearance ratio of palpitations
Measured: 7 days
Frequency of pharyngeal discomfort
Measured: From discharge to 6 months
Mean duration of pharyngeal discomfort
Measured: From discharge to 6 months
Duration of pharyngeal discomfort before discharge
Measured: 6 months
Disappearance ratio of pharyngeal discomfort
Measured: 7 days
Frequency of headache
Measured: From discharge to 6 months
Mean duration of headache
Measured: From discharge to 6 months
Duration of headache before discharge
Measured: 6 months
Disappearance ratio of headache
Measured: 7 days
Frequency of dizziness
Measured: From discharge to 6 months
Mean duration of dizziness
Measured: From discharge to 6 months
Duration of dizziness before discharge
Measured: 6 months
Disappearance ratio of dizziness
Measured: 7 days
Frequency of toothache
Measured: From discharge to 6 months
Mean duration of toothache
Measured: From discharge to 6 months
Duration of toothache before discharge
Measured: 6 months
Disappearance ratio of toothache
Measured: 7 days
Frequency of muscle soreness
Measured: From discharge to 6 months
Mean duration of muscle soreness
Measured: From discharge to 6 months
Duration of muscle soreness before discharge
Measured: 6 months
Disappearance ratio of muscle soreness
Measured: 7 days
Frequency of physical decline
Measured: From discharge to 6 months
Mean duration of physical decline
Measured: From discharge to 6 months
Duration of physical decline before discharge
Measured: 6 months
Disappearance ratio of physical decline
Measured: 7 days
Frequency of gastrointestinal symptoms
Measured: From discharge to 6 months
Mean duration of gastrointestinal symptoms
Measured: From discharge to 6 months
Duration of gastrointestinal symptoms before discharge
Measured: 6 months
Disappearance ratio of gastrointestinal symptoms
Measured: 7 days
Frequency of urinary symptoms
Measured: From discharge to 6 months
Mean duration of urinary symptoms
Measured: From discharge to 6 months
Duration of urinary symptoms before discharge
Measured: 6 months
Disappearance ratio of urinary symptoms
Measured: 7 days
Drug-related adverse events
Measured: 6 months
Drug-related adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
- Investigators
- Panpan Hao, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625035
- Sponsor's protocol ID
- Lianhua Qingwen 2022
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 22 Nov 2022
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lianhua Qingwen in the Long-Term Rehabilitation of Patients With Coronavirus Infection: a Randomized, Open-Label, Comparative Study
- ClinicalTrials.gov ID
- NCT05625035
- Acronym / sponsor ID
- Lianhua Qingwen 2022
- Conditions
- Coronavirus, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Nov 2022 (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.
The patients with coronavirus infection usually have fever, respiratory symptoms, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with coronavirus infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingwen capsules in patients with coronavirus infection. The duration of viral shedding and symptoms before discharge, as well as the negative conversion ratio and disappearance ratio of main symptoms after 7-day treatment, will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingwen on all infection events and the long-term rehabilitation of the symptoms induced by coronavirus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lianhua Qingwen plus conventional therapy | Experimental | Drug: Lianhua Qingwen capsules |
| Conventional therapy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed SARS-CoV-2 Infection by virus testing;
- ≥18 years of age;
- informed consent provided.
Key exclusion criteria (8 listed)
- overt bacterial infection in the respiratory tract resulting from common pathologies, including primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
- asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g., purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and further respiratory tract pathologies potentially affecting the trial's data analysis;
- common pulmonary diseases (e.g., severe pulmonary interstitial lesions and bronchiectasis) confirmed by chest CT;
- severe pneumonia requiring ventilator use;
- previous or present diseases potentially affecting trial participation or influencing study outcome, based on the investigator's judgment;
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 |
|---|---|---|
| Lianhua Qingwen capsulesLianhua Qingwen capsules: 4 capsules once, three times daily | Drug | Lianhua Qingwen plus conventional therapy |
Primary outcome
Incidence of all Infection events
Time frame: From discharge to 6 months
Recurrence coronavirus infection or any new infection events
68 secondary outcomes
Duration of viral shedding
Time frame: 6 months
Negative conversion ratio
Time frame: 7 days
Positive conversion ratio
Time frame: From discharge to 6 months
Duration of main symptoms before discharge
Time frame: 6 months
Disappearance ratio of main symptoms
Time frame: 7 days
Recurrence frequency of main clinical symptoms
Time frame: From discharge to 6 months
Mean duration of main clinical symptoms
Time frame: From discharge to 6 months
Heart rate
Time frame: 6 months
Heart rate
Time frame: 7 days
Heart rate
Time frame: Baseline
Blood pressure
Time frame: 6 months
Blood pressure
Time frame: 7 days
Blood pressure
Time frame: Baseline
Infection events except SARS-CoV-2
Time frame: From discharge to 6 months
Frequency of fever
Time frame: From discharge to 6 months
Mean duration of fever
Time frame: From discharge to 6 months
Duration of fever before discharge
Time frame: 6 months
Disappearance ratio of fever
Time frame: 7 days
Frequency of respiratory symptoms
Time frame: From discharge to 6 months
Mean duration of respiratory symptoms
Time frame: From discharge to 6 months
Duration of respiratory symptoms before discharge
Time frame: 6 months
Disappearance ratio of respiratory symptoms
Time frame: 7 days
Frequency of nasal congestion or runny nose
Time frame: From discharge to 6 months
Mean duration of nasal congestion or runny nose
Time frame: From discharge to 6 months
Duration of nasal congestion or runny nose before discharge
Time frame: 6 months
Disappearance ratio of nasal congestion or runny nose
Time frame: 7 days
Frequency of chest distress
Time frame: From discharge to 6 months
Mean duration of chest distress
Time frame: From discharge to 6 months
Duration of chest distress before discharge
Time frame: 6 months
Disappearance ratio of chest distress
Time frame: 7 days
Frequency of palpitations
Time frame: From discharge to 6 months
Mean duration of palpitations
Time frame: From discharge to 6 months
Duration of palpitations before discharge
Time frame: 6 months
Disappearance ratio of palpitations
Time frame: 7 days
Frequency of pharyngeal discomfort
Time frame: From discharge to 6 months
Mean duration of pharyngeal discomfort
Time frame: From discharge to 6 months
Duration of pharyngeal discomfort before discharge
Time frame: 6 months
Disappearance ratio of pharyngeal discomfort
Time frame: 7 days
Frequency of headache
Time frame: From discharge to 6 months
Mean duration of headache
Time frame: From discharge to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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.
Panpan Hao, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lianhua Qingwen capsules in people with Coronavirus and Traditional Chinese Medicine, run by Qilu Hospital of Shandong 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 3 inclusion and 8 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 22 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Panpan Hao, MD (86-18560086593, panda.how@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all Infection events (time frame: From discharge to 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 22 Nov 2022.