2019 Novel Coronavirus InfectionSMART-CORENCT05375773
Povidone Iodine Nasal Irrigation and Gargling to Reduce Viral Load in Asymptomatic Patients With COVID-19
A study testing PVP-I Nasal Irrigation and gargling in people with 2019 Novel Coronavirus Infection, run by Ruijin Hospital at 1 site in China.
Trial summary
The emergence of a novel coronavirus(SARS-CoV-2) in late 2019 has resulted in a global epidemic of the infectious condition COVID-19. Since March 2022, the Omicron mutant has caused widespread transmission in Shanghai, China, and is characterized by the majority of asymptomatic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019 Novel Coronavirus Infection
- What is being tested?
- PVP-I Nasal Irrigation and gargling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2022to 31 Oct 2022
- Phase
- Interventional
- 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
- Patients nucleic acid testing positive for COVID-19.
- Diagnose as asymptomatic patients infected by COVID-19, and receive medical observation at a Fang Chang Hospital.
- Be able to understand this study, willing to participate in, and sign the informed consent form.
- Commit to follow the research procedures and cooperate in the implementation of the whole process research.
- Can communicate with researchers through smart phones.
Who cannot join
- The nucleic acid test result of novel coronavirus has always been negative after entering the Fang Chang Hospital.
- patients who have history of nasal surgery, or current use of nasal saline irrigation or other intranasal medications.
- Patients with thyroid diseases , respiratory diseases or other serious basic diseases.
- Allergy to iodine.
- Participation in another prospective COVID related research project(clinical trial).
- Pregnancy or lactation
- Patients with immune deficiency (such as patients with malignant tumors, organ or bone marrow transplantation, patients with AIDS, and those taking immunosuppressive drugs within 3 months before screening).
- Other patients considered unsuitable by the investigator to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital,Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality
Meiqin Xue, 18917762673, xmq21966@rjh.com.cn
About this study
Official title: A Single-center, Open-label, Randomized Controlled Trial to Evaluate the Efficacy of Sino-nasal and Mouth Cavity Rinse With an Iodine-based Solution in Reducing Viral Load in Asymptomatic Coronavirus Diseases (COVID-19)
The emergence of a novel coronavirus(SARS-CoV-2) in late 2019 has resulted in a global epidemic of the infectious condition COVID-19. Since March 2022, the Omicron mutant has caused widespread transmission in Shanghai, China, and is characterized by the majority of asymptomatic patients. Although showing no obvious symptoms, the asymptomatic patients have high transmissibility because of high viral loads in their oropharynx and nasopharynx. Therefore，this study puts forwards the hypothesis that local flushing treatment in the sino-nasal and mouth cavity can reduce the viral load to reduce their transmissibility.
Nasal Irrigation and gargling is a safe and commonly used mechanism to treat a variety of sinonasal diseases including sinusitis, rhinitis, and upper respiratory tract infections. Povidone-iodine(PVP-I) is a water-soluble complex of povidone, a carrier molecule, and iodine, which has powerful microbicidal activity. Also, recent evidence of in-vitro virucidal action of povidone-iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2) has been supported.
Therefore, the study is designed to assess the virucidal effect of nasal irrigation and gargling with PVP-I against SARS-CoV-2 located in the throat. The hypothesis was that the treatment would be effective in improving the negative conversion rate of SARS-CoV-2 nucleic acid on day 10.
Read the detailed description
The purpose of the study is to evaluate if using nasal irrigation and gargling with PVP-I and hypertonic saline solution, can improve the negative conversion rate of SARS-CoV-2 nucleic acid on day 10 and reduce the incidence rate and severity of symptoms associated with COVID-19.
The study is a prospective, single-center, open-label, randomized controlled trial. The subjects who met the inclusion criteria were stratified according to gender, and randomly divided into control group and experimental group. Both groups were treated according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). Of them, the control group is as blank control, and the experimental group was rinsed with PVP-I containing hypertonic lotion prepared by 0.9% Normal saline（NS）, 10% sodium chloride（NaCl）, and povidone-iodine（PVP-I） gargle four times a day.
The participants in the control group and the experimental group will be required to fill in a daily record and report the main complaint of discomfort. The subjects in the experimental group are also asked to record the implementation of oral and nasal flushing every day.
The researchers are going to record the test results of novel coronavirus nucleic acid samples from the nasopharynx of all subjects in the control group and the experimental group every day.
- Conditions
- 2019 Novel Coronavirus Infection
- Being tested
- PVP-I Nasal Irrigation and gargling
- Keywords
- Povidone-Iodine, Nasal Lavage and gargling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVP-I Nasal Irrigation and garglingOther
The solution is prepared by the researcher, which contains 0.5% PVP-I and 2.27% hypertonic saline
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the Control group accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). |
| PVP-I Nasal Irrigation and gargling | Experimental | Participants in the intervention arm will be required to perform Nasal Irrigation and gargling 4 times daily. They will also accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). Receives: Other: PVP-I Nasal Irrigation and gargling |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative conversion rate
On the 10th day after entering the Fang Chang Hospital, the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling. the "turning negative" is defined as the person whose nucleic acid detection is negative for two times after an interval of more than 24 hours according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition).
Measured: the 10th day after entering the Fang Chang Hospital
Secondary outcomes (5)
negative conversion rate
the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling
Measured: the 5th 、7th and 14th day after entering the Fang Chang Hospital
the length of time for patient s when nucleic acid result turns to be negative
Number of days
Measured: 1-14 days or until the nucleic acid result is negative
Intraoral viral load
Intraoral viral load as deciphered by Reverse transcription polymerase chain reaction (RT-PCR) testing
Measured: 10th day of using Nasal Irrigation and gargling
Number of participants reporting side effects of nasal irrigation
Number of participants in intervention arm reporting side effects
Measured: 1-14 days or until the participant reports that they are well
Self-reported clinical discomfort
Number of participants reported, including headache, cough, runny nose, chest pain, fever, muscle soreness / fatigue, diarrhea / nausea / vomiting, loss of taste / smell and other symptoms
Measured: 1-14 days or until the participant reports that they are well
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start16 Apr 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for 2019 Novel Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WU Beiwen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375773
- Sponsor's protocol ID
- xmq21966
- Acronym
- SMART-CORE
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
PubMed 32074444Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18.
PubMed 27513397Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.
PubMed 18209140Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.
PubMed 30705369Ramalingam S, Cai B, Wong J, Twomey M, Chen R, Fu RM, Boote T, McCaughan H, Griffiths SJ, Haas JG. Antiviral innate immune response in non-myeloid cells is augmented by chloride ions via an increase in intracellular hypochlorous acid levels. Sci Rep. 2018 Sep 11;8(1):13630. doi: 10.1038/s41598-018-31936-y.
PubMed 30206371Vogt PM, Hauser J, Mueller S, Bosse B, Hopp M. Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study. Infect Dis Ther. 2017 Dec;6(4):545-555. doi: 10.1007/s40121-017-0172-z. Epub 2017 Oct 10.
PubMed 29019097Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.
PubMed 29633177Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212 Suppl 1(Suppl 1):119-23. doi: 10.1159/000089211.
PubMed 16490989Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.
PubMed 26416214Anderson DE, Sivalingam V, Kang AEZ, Ananthanarayanan A, Arumugam H, Jenkins TM, Hadjiat Y, Eggers M. Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease. Infect Dis Ther. 2020 Sep;9(3):669-675. doi: 10.1007/s40121-020-00316-3. Epub 2020 Jul 8.
PubMed 32643111Arefin MK, Rumi SKNF, Uddin AKMN, Banu SS, Khan M, Kaiser A, Chowdhury JA, Khan MAS, Hasan MJ. Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: an open-label randomized clinical trial. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2963-2967. doi: 10.1007/s12070-021-02616-7. Epub 2021 May 18.
PubMed 34026595
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Randomized Controlled Trial to Evaluate the Efficacy of Sino-nasal and Mouth Cavity Rinse With an Iodine-based Solution in Reducing Viral Load in Asymptomatic Coronavirus Diseases (COVID-19)
- ClinicalTrials.gov ID
- NCT05375773
- Acronym / sponsor ID
- SMART-CORE / xmq21966
- Conditions
- 2019 Novel Coronavirus Infection
- Keywords
- Povidone-Iodine, Nasal Lavage and gargling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 17 May 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 emergence of a novel coronavirus(SARS-CoV-2) in late 2019 has resulted in a global epidemic of the infectious condition COVID-19. Since March 2022, the Omicron mutant has caused widespread transmission in Shanghai, China, and is characterized by the majority of asymptomatic patients. Although showing no obvious symptoms, the asymptomatic patients have high transmissibility because of high viral loads in their oropharynx and nasopharynx. Therefore，this study puts forwards the hypothesis that local flushing treatment in the sino-nasal and mouth cavity can reduce the viral load to reduce their transmissibility.
Nasal Irrigation and gargling is a safe and commonly used mechanism to treat a variety of sinonasal diseases including sinusitis, rhinitis, and upper respiratory tract infections. Povidone-iodine(PVP-I) is a water-soluble complex of povidone, a carrier molecule, and iodine, which has powerful microbicidal activity. Also, recent evidence of in-vitro virucidal action of povidone-iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2) has been supported.
Therefore, the study is designed to assess the virucidal effect of nasal irrigation and gargling with PVP-I against SARS-CoV-2 located in the throat. The hypothesis was that the treatment would be effective in improving the negative conversion rate of SARS-CoV-2 nucleic acid on day 10.
Detailed description
The purpose of the study is to evaluate if using nasal irrigation and gargling with PVP-I and hypertonic saline solution, can improve the negative conversion rate of SARS-CoV-2 nucleic acid on day 10 and reduce the incidence rate and severity of symptoms associated with COVID-19.
The study is a prospective, single-center, open-label, randomized controlled trial. The subjects who met the inclusion criteria were stratified according to gender, and randomly divided into control group and experimental group. Both groups were treated according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). Of them, the control group is as blank control, and the experimental group was rinsed with PVP-I containing hypertonic lotion prepared by 0.9% Normal saline（NS）, 10% sodium chloride（NaCl）, and povidone-iodine（PVP-I） gargle four times a day.
The participants in the control group and the experimental group will be required to fill in a daily record and report the main complaint of discomfort. The subjects in the experimental group are also asked to record the implementation of oral and nasal flushing every day.
The researchers are going to record the test results of novel coronavirus nucleic acid samples from the nasopharynx of all subjects in the control group and the experimental group every day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the Control group accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). |
| PVP-I Nasal Irrigation and gargling | Experimental | Other: PVP-I Nasal Irrigation and garglingParticipants in the intervention arm will be required to perform Nasal Irrigation and gargling 4 times daily. They will also accept standard treatment for the management of their symptoms according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients nucleic acid testing positive for COVID-19.
- Diagnose as asymptomatic patients infected by COVID-19, and receive medical observation at a Fang Chang Hospital.
- Be able to understand this study, willing to participate in, and sign the informed consent form.
- Commit to follow the research procedures and cooperate in the implementation of the whole process research.
- Can communicate with researchers through smart phones.
Key exclusion criteria (8 listed)
- The nucleic acid test result of novel coronavirus has always been negative after entering the Fang Chang Hospital.
- patients who have history of nasal surgery, or current use of nasal saline irrigation or other intranasal medications.
- Patients with thyroid diseases , respiratory diseases or other serious basic diseases.
- Allergy to iodine.
- Participation in another prospective COVID related research project(clinical trial).
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 |
|---|---|---|
| PVP-I Nasal Irrigation and garglingThe solution is prepared by the researcher, which contains 0.5% PVP-I and 2.27% hypertonic saline | Other | PVP-I Nasal Irrigation and gargling |
Primary outcome
negative conversion rate
Time frame: the 10th day after entering the Fang Chang Hospital
On the 10th day after entering the Fang Chang Hospital, the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling. the "turning negative" is defined as the person whose nucleic acid detection is negative for two times after an interval of more than 24 hours according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition).
5 secondary outcomes
negative conversion rate
Time frame: the 5th 、7th and 14th day after entering the Fang Chang Hospital
the length of time for patient s when nucleic acid result turns to be negative
Time frame: 1-14 days or until the nucleic acid result is negative
Intraoral viral load
Time frame: 10th day of using Nasal Irrigation and gargling
Number of participants reporting side effects of nasal irrigation
Time frame: 1-14 days or until the participant reports that they are well
Self-reported clinical discomfort
Time frame: 1-14 days or until the participant reports that they are well
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 32074444Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 27513397Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18.
- Background: PubMed 18209140Slapak I, Skoupa J, Strnad P, Hornik P. Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children. Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74. doi: 10.1001/archoto.2007.19.
- Background: PubMed 30705369Ramalingam S, Graham C, Dove J, Morrice L, Sheikh A. A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold. Sci Rep. 2019 Jan 31;9(1):1015. doi: 10.1038/s41598-018-37703-3.
- Background: PubMed 30206371Ramalingam S, Cai B, Wong J, Twomey M, Chen R, Fu RM, Boote T, McCaughan H, Griffiths SJ, Haas JG. Antiviral innate immune response in non-myeloid cells is augmented by chloride ions via an increase in intracellular hypochlorous acid levels. Sci Rep. 2018 Sep 11;8(1):13630. doi: 10.1038/s41598-018-31936-y.
- Background: PubMed 29019097Vogt PM, Hauser J, Mueller S, Bosse B, Hopp M. Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study. Infect Dis Ther. 2017 Dec;6(4):545-555. doi: 10.1007/s40121-017-0172-z. Epub 2017 Oct 10.
- Background: PubMed 29633177Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.
- Background: PubMed 16490989Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212 Suppl 1(Suppl 1):119-23. doi: 10.1159/000089211.
- Background: PubMed 26416214Eggers M, Eickmann M, Zorn J. Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther. 2015 Dec;4(4):491-501. doi: 10.1007/s40121-015-0091-9. Epub 2015 Sep 28.
- Background: PubMed 32643111Anderson DE, Sivalingam V, Kang AEZ, Ananthanarayanan A, Arumugam H, Jenkins TM, Hadjiat Y, Eggers M. Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease. Infect Dis Ther. 2020 Sep;9(3):669-675. doi: 10.1007/s40121-020-00316-3. Epub 2020 Jul 8.
- Background: PubMed 34026595Arefin MK, Rumi SKNF, Uddin AKMN, Banu SS, Khan M, Kaiser A, Chowdhury JA, Khan MAS, Hasan MJ. Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: an open-label randomized clinical trial. Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):2963-2967. doi: 10.1007/s12070-021-02616-7. Epub 2021 May 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVP-I Nasal Irrigation and gargling in people with 2019 Novel Coronavirus Infection, run by Ruijin Hospital 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 5 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 24 May 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.
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 Meiqin Xue (18917762673, xmq21966@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative conversion rate (time frame: the 10th day after entering the Fang Chang Hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05375773, which also lists 11 linked publications.
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 24 May 2022.