Long COVIDNCT06054438
Examining the Function of Cs4 on Post-COVID-19 Disorders
A study testing Chinese medicine nutritional supplement Cs4 in people with Long COVID, run by The University of Hong Kong at 1 site in China.
Trial summary
Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeutic action have been studied due to its anti-inflammation and immunomodulation features. Thus, Cordyceps may have efficacy against health problems in the post-COVID era. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Chinese medicine nutritional supplement Cs4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 31 Mar 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
- The self-declared post-COVID-19 Functional Status scale should be at least over 1;
- The post-COVID symptoms have lasted at least 28 days after diagnosis;
- Currently not taking any other orally administered Chinese medicine;
- Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
- Voluntary participation in this clinical study.
Who cannot join
- Inability to read and/or write Chinese or English;
- Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;
- 4. Pregnant or lactating women; 5. Impaired hepatic or renal function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Immunomodulatory and Health Improving Function of a Chinese Medicine Nutritional Supplement Cs4 on Immunity-related Disorders in the Post-COVID Era
Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeutic action have been studied due to its anti-inflammation and immunomodulation features. Thus, Cordyceps may have efficacy against health problems in the post-COVID era. the Cs4 is a Chinese medicine nutritional supplement fermented by Cordyceps. This Project conducts a two-stage waitlist-controlled trial to examine the therapeutic effect of the Cs4 on long-COVID patients. 110 Patients will be recruited and divided into two groups. Each group contains 55 patients. In the first-stage clinical trial for 12 weeks, group A will have treatment while group B will have no Cs4 treatment. In the second-stage clinical trial for 12 weeks, group A will have no Cs4 treatment while group B will have Cs4 treatment. A 12-week follow-up will be conducted after the intervention of Cs4 for group A. The primary outcome will be the change from 0 to 12 weeks in symptom severity measured by self-declared modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm). In our study, we intend to analyse the efficacy of Cs4 on the improvement of long Covid symptoms by using a comprehensive measurement to cover most symptoms, and be condition-specific. The secondary outcomes will include the change from 0 to 12 weeks of Insomnia Severity Index (ISI), Brief Fatigue Inventory Form, St. George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), and the Short Form 12 (SF12). Blood tests will be assessed for safety study. primary outcomes and secondary outcomes will be assessed at baseline (week 0) and week 12. The anticipated outcome of the study is to provide evidence of Cs4 in the improvement of long COVID symptoms. This project can serve to the development of a nutritional supplement for the management of post-COVID-related health problems.
Read the detailed description
Research Methodologies Participants Setting This is a waitlist-controlled trial to examine the therapeutic effect of Cs4 on long-COVID patients, which are divided into two groups. The study will be conducted in the Specialist Clinical Centre for Teaching and Research (Sassoon Road), School of Chinese Medicine, The University of Hong Kong (HKU).
Inclusion Criteria
- Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
- The self-declared post-COVID-19 Functional Status scale should be at least over 1;
- The post-COVID symptoms have lasted at least 28 days after diagnosis;
- Currently not taking any other orally administered Chinese medicine;
- Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
- Voluntary participation in this clinical study. Exclusion Criteria
- Inability to read and/or write Chinese or English; 2. Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis; 4. Pregnant or lactating women; 5. Impaired hepatic or renal function. Methods Participants will be recruited through the webpage of the School of Chinese Medicine, HKU. Clinical history and comprehensive examination will be performed during the first interview by registered Chinese Medicine practitioners or registered nurses who will be informed about the aims, procedure and nature of the study, and possible side effects of Cs4 and written consent will be obtained from each subject who agrees to get into the study. The participant will be also informed that they have the freedom to withdraw at any time during the study.
Study design This will be a waitlist-controlled trial in which participants will alternately receive the intervention of Cs4 for 12 weeks, followed by a 12-week follow-up. 110 long-COVID patients will be randomly divided into two groups (Group A and Group B). Randomisation will be carried out according to the computer- based Excel random number generator. An integer number between 1 and 110 will be assigned to each individual at random. Group A consists of individuals assigned integer numbers between 1 and 55. Group B consists of individuals assigned integer numbers between 56 and 110.
Intervention Cs4 will be provided by Chinese Pharm, produced by GMP standard manufacturing. The intervention will be given according to the product instruction. Each capsule is 0.4g. According to the product sheet, adults should take 3-4 capsules daily as a way to nourish and strengthen the lungs and kidneys. In our study, the participants are people with long-COVID symptoms. Therefore, in order to achieve maximum efficacy, we will follow the directions and let participants take the maximum amount allowed by the product which is 4 capsules daily. Participants will take one capsule (each 400mg) 4 times a day, for a total of 1.6g. Treatment will last 12 weeks.
- Conditions
- Long COVID
- Being tested
- Chinese medicine nutritional supplement Cs4
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine nutritional supplement Cs4Other
Cs4 will be provided by Chinese Pharm, produced by GMP standard manufacturing. The intervention will be given according to the product instruction. Each capsule is 0.4g. According to the product sheet, adults should take 3-4 capsules daily as a way to nourish and strengthen the lungs and kidneys. In our study, the participants are people with long-COVID symptoms. Therefore, in order to achieve maximum efficacy, we will follow the directions and let participants take the maximum amount allowed by the product which is 4 capsules daily. Participants will take one capsule (each 400mg) 4 times a day, for a total of 1.6g. Treatment will last 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A- having treatment at first stage | Other | 110 long-COVID patients will be divided into 2 groups (55 individuals per group).
⚫ Group A: 55 long-COVID patients (NO. 1- NO.55) Group B: 55 long-COVID patients (NO. 56- NO.110)
Group distribution and treatment in a two-stage waitlist design: ⚫ First-stage clinical trial for 12 weeks:
Group A (patients NO.1-55 will have treatment) Group B (patients NO.56-110 will have no Cs4 treatment on the waiting list)
⚫ Second-stage clinical trial for 12 weeks (After finishing the first-stage study): Group A (patients NO.1-55 will have no Cs4 treatment) Group B (patients NO.56-110 will have Cs4 treatment) Receives: Other: Chinese medicine nutritional supplement Cs4 |
| Group B- having treatment at secondstage | Other | 110 long-COVID patients will be divided into 2 groups (55 individuals per group).
⚫ Group A: 55 long-COVID patients (NO. 1- NO.55) Group B: 55 long-COVID patients (NO. 56- NO.110)
Group distribution and treatment in a two-stage waitlist design: ⚫ First-stage clinical trial for 12 weeks:
Group A (patients NO.1-55 will have treatment) Group B (patients NO.56-110 will have no Cs4 treatment on the waiting list)
⚫ Second-stage clinical trial for 12 weeks (After finishing the first-stage study): Group A (patients NO.1-55 will have no Cs4 treatment) Group B (patients NO.56-110 will have Cs4 treatment) Receives: Other: Chinese medicine nutritional supplement Cs4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in symptom severity from 0 to 12 weeks measured by the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Symptom severity is one of the sub-scale of C19-YRSm. Range 0-78, with higher scores indicating greater impact of symptoms. C19-YRSm is the first validated scale describing post-COVID-19 symptoms and grading the severity of symptoms and functional disability.
Measured: will be assessed at baseline and 12 weeks.
Secondary outcomes (5)
the change in Insomnia Severity Index (ISI) from 0 to 12 weeks
To evaluate insomnia. Maximum values: 28, minimum values:0. Higher scores mean a worse outcome.
Measured: will be assessed at baseline and 12 weeks.
the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks
To evaluate fatigue. Maximum values: 10, minimum values:0. Higher scores mean a worse outcome.
Measured: will be assessed at baseline and 12 weeks.
the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks
To evaluate respiratory symptoms. Maximum values: 100, minimum values:0. Higher scores mean a worse outcome.
Measured: will be assessed at baseline and 12 weeks.
the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks
To evaluate anxiety and depression. Maximum values: 21, minimum values:0. Higher scores mean a worse outcome.
Measured: will be assessed at baseline and 12 weeks.
the change in Short Form 12 (SF12) from 0 to 12 weeks
To evaluate overall quality of life. Maximum values: 100, minimum values:0. Higher scores mean better physical and mental health functioning.
Measured: will be assessed at baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start17 Apr 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor FENG Yibin, The University of Hong Kong
- Investigators
- Yibin Feng, Doctor, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054438
- Sponsor's protocol ID
- UW23-011
- Other IDs
- Innovation and Technology Fund
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitworth J. COVID-19: a fast evolving pandemic. Trans R Soc Trop Med Hyg. 2020 Apr 8;114(4):241-248. doi: 10.1093/trstmh/traa025. No abstract available.
PubMed 32198918Garg M, Maralakunte M, Garg S, Dhooria S, Sehgal I, Bhalla AS, Vijayvergiya R, Grover S, Bhatia V, Jagia P, Bhalla A, Suri V, Goyal M, Agarwal R, Puri GD, Sandhu MS. The Conundrum of 'Long-COVID-19': A Narrative Review. Int J Gen Med. 2021 Jun 14;14:2491-2506. doi: 10.2147/IJGM.S316708. eCollection 2021.
PubMed 34163217Chen J, Chan WM, Leung HY, Leong PK, Yan CTM, Ko KM. Anti-Inflammatory Effects of a Cordyceps sinensis Mycelium Culture Extract (Cs-4) on Rodent Models of Allergic Rhinitis and Asthma. Molecules. 2020 Sep 4;25(18):4051. doi: 10.3390/molecules25184051.
PubMed 32899766Han F, Dou M, Wang Y, Xu C, Li Y, Ding X, Xue W, Zheng J, Tian P, Ding C. Cordycepin protects renal ischemia/reperfusion injury through regulating inflammation, apoptosis, and oxidative stress. Acta Biochim Biophys Sin (Shanghai). 2020 Feb 3;52(2):125-132. doi: 10.1093/abbs/gmz145.
PubMed 31951250Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.
PubMed 32398306Sivan M, Preston N, Parkin A, Makower S, Gee J, Ross D, Tarrant R, Davison J, Halpin S, O'Connor RJ, Horton M. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) patient-reported outcome measure for Long Covid or Post-COVID-19 syndrome. J Med Virol. 2022 Sep;94(9):4253-4264. doi: 10.1002/jmv.27878. Epub 2022 Jun 1.
PubMed 35603810
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Immunomodulatory and Health Improving Function of a Chinese Medicine Nutritional Supplement Cs4 on Immunity-related Disorders in the Post-COVID Era
- ClinicalTrials.gov ID
- NCT06054438
- Acronym / sponsor ID
- UW23-011
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Sep 2023 (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.
Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeutic action have been studied due to its anti-inflammation and immunomodulation features. Thus, Cordyceps may have efficacy against health problems in the post-COVID era. the Cs4 is a Chinese medicine nutritional supplement fermented by Cordyceps. This Project conducts a two-stage waitlist-controlled trial to examine the therapeutic effect of the Cs4 on long-COVID patients. 110 Patients will be recruited and divided into two groups. Each group contains 55 patients. In the first-stage clinical trial for 12 weeks, group A will have treatment while group B will have no Cs4 treatment. In the second-stage clinical trial for 12 weeks, group A will have no Cs4 treatment while group B will have Cs4 treatment. A 12-week follow-up will be conducted after the intervention of Cs4 for group A. The primary outcome will be the change from 0 to 12 weeks in symptom severity measured by self-declared modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm). In our study, we intend to analyse the efficacy of Cs4 on the improvement of long Covid symptoms by using a comprehensive measurement to cover most symptoms, and be condition-specific. The secondary outcomes will include the change from 0 to 12 weeks of Insomnia Severity Index (ISI), Brief Fatigue Inventory Form, St. George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), and the Short Form 12 (SF12). Blood tests will be assessed for safety study. primary outcomes and secondary outcomes will be assessed at baseline (week 0) and week 12. The anticipated outcome of the study is to provide evidence of Cs4 in the improvement of long COVID symptoms. This project can serve to the development of a nutritional supplement for the management of post-COVID-related health problems.
Detailed description
Research Methodologies Participants Setting This is a waitlist-controlled trial to examine the therapeutic effect of Cs4 on long-COVID patients, which are divided into two groups. The study will be conducted in the Specialist Clinical Centre for Teaching and Research (Sassoon Road), School of Chinese Medicine, The University of Hong Kong (HKU).
Inclusion Criteria
- Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
- The self-declared post-COVID-19 Functional Status scale should be at least over 1;
- The post-COVID symptoms have lasted at least 28 days after diagnosis;
- Currently not taking any other orally administered Chinese medicine;
- Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
- Voluntary participation in this clinical study. Exclusion Criteria
- Inability to read and/or write Chinese or English; 2. Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis; 4. Pregnant or lactating women; 5. Impaired hepatic or renal function. Methods Participants will be recruited through the webpage of the School of Chinese Medicine, HKU. Clinical history and comprehensive examination will be performed during the first interview by registered Chinese Medicine practitioners or registered nurses who will be informed about the aims, procedure and nature of the study, and possible side effects of Cs4 and written consent will be obtained from each subject who agrees to get into the study. The participant will be also informed that they have the freedom to withdraw at any time during the study.
Study design This will be a waitlist-controlled trial in which participants will alternately receive the intervention of Cs4 for 12 weeks, followed by a 12-week follow-up. 110 long-COVID patients will be randomly divided into two groups (Group A and Group B). Randomisation will be carried out according to the computer- based Excel random number generator. An integer number between 1 and 110 will be assigned to each individual at random. Group A consists of individuals assigned integer numbers between 1 and 55. Group B consists of individuals assigned integer numbers between 56 and 110.
Intervention Cs4 will be provided by Chinese Pharm, produced by GMP standard manufacturing. The intervention will be given according to the product instruction. Each capsule is 0.4g. According to the product sheet, adults should take 3-4 capsules daily as a way to nourish and strengthen the lungs and kidneys. In our study, the participants are people with long-COVID symptoms. Therefore, in order to achieve maximum efficacy, we will follow the directions and let participants take the maximum amount allowed by the product which is 4 capsules daily. Participants will take one capsule (each 400mg) 4 times a day, for a total of 1.6g. Treatment will last 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A- having treatment at first stage | Other | Other: Chinese medicine nutritional supplement Cs4110 long-COVID patients will be divided into 2 groups (55 individuals per group). ⚫ Group A: 55 long-COVID patients (NO. 1- NO.55) Group B: 55 long-COVID patients (NO. 56- NO.110) Group distribution and treatment in a two-stage waitlist design: ⚫ First-stage clinical trial for 12 weeks: Group A (patients NO.1-55 will have treatment) Group B (patients NO.56-110 will have no Cs4 treatment on the waiting list) ⚫ Second-stage clinical trial for 12 weeks (After finishing the first-stage study): Group A (patients NO.1-55 will have no Cs4 treatment) Group B (patients NO.56-110 will have Cs4 treatment) |
| Group B- having treatment at secondstage | Other | Other: Chinese medicine nutritional supplement Cs4110 long-COVID patients will be divided into 2 groups (55 individuals per group). ⚫ Group A: 55 long-COVID patients (NO. 1- NO.55) Group B: 55 long-COVID patients (NO. 56- NO.110) Group distribution and treatment in a two-stage waitlist design: ⚫ First-stage clinical trial for 12 weeks: Group A (patients NO.1-55 will have treatment) Group B (patients NO.56-110 will have no Cs4 treatment on the waiting list) ⚫ Second-stage clinical trial for 12 weeks (After finishing the first-stage study): Group A (patients NO.1-55 will have no Cs4 treatment) Group B (patients NO.56-110 will have Cs4 treatment) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
- The self-declared post-COVID-19 Functional Status scale should be at least over 1;
- The post-COVID symptoms have lasted at least 28 days after diagnosis;
- Currently not taking any other orally administered Chinese medicine;
- Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
Key exclusion criteria (3 listed)
- Inability to read and/or write Chinese or English;
- Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;
- 4. Pregnant or lactating women; 5. Impaired hepatic or renal function.
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 |
|---|---|---|
| Chinese medicine nutritional supplement Cs4Cs4 will be provided by Chinese Pharm, produced by GMP standard manufacturing. The intervention will be given according to the product instruction. Each capsule is 0.4g. According to the product sheet, adults should take 3-4 capsules daily as a way to nourish and strengthen the lungs and kidneys. In our study, the participants are people with long-COVID symptoms. Therefore, in order to achieve maximum efficacy, we will follow the directions and let participants take the maximum amount allowed by the product which is 4 capsules daily. Participants will take one capsule (each 400mg) 4 times a day, for a total of 1.6g. Treatment will last 12 weeks. | Other | Group A- having treatment at first stage, Group B- having treatment at secondstage |
Primary outcome
the change in symptom severity from 0 to 12 weeks measured by the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm)
Time frame: will be assessed at baseline and 12 weeks.
Symptom severity is one of the sub-scale of C19-YRSm. Range 0-78, with higher scores indicating greater impact of symptoms. C19-YRSm is the first validated scale describing post-COVID-19 symptoms and grading the severity of symptoms and functional disability.
5 secondary outcomes
the change in Insomnia Severity Index (ISI) from 0 to 12 weeks
Time frame: will be assessed at baseline and 12 weeks.
the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks
Time frame: will be assessed at baseline and 12 weeks.
the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks
Time frame: will be assessed at baseline and 12 weeks.
the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks
Time frame: will be assessed at baseline and 12 weeks.
the change in Short Form 12 (SF12) from 0 to 12 weeks
Time frame: will be assessed at baseline and 12 weeks.
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 9 Jul 2024.
- Background: PubMed 32198918Whitworth J. COVID-19: a fast evolving pandemic. Trans R Soc Trop Med Hyg. 2020 Apr 8;114(4):241-248. doi: 10.1093/trstmh/traa025. No abstract available.
- Background: PubMed 34163217Garg M, Maralakunte M, Garg S, Dhooria S, Sehgal I, Bhalla AS, Vijayvergiya R, Grover S, Bhatia V, Jagia P, Bhalla A, Suri V, Goyal M, Agarwal R, Puri GD, Sandhu MS. The Conundrum of 'Long-COVID-19': A Narrative Review. Int J Gen Med. 2021 Jun 14;14:2491-2506. doi: 10.2147/IJGM.S316708. eCollection 2021.
- Background: PubMed 32899766Chen J, Chan WM, Leung HY, Leong PK, Yan CTM, Ko KM. Anti-Inflammatory Effects of a Cordyceps sinensis Mycelium Culture Extract (Cs-4) on Rodent Models of Allergic Rhinitis and Asthma. Molecules. 2020 Sep 4;25(18):4051. doi: 10.3390/molecules25184051.
- Background: PubMed 31951250Han F, Dou M, Wang Y, Xu C, Li Y, Ding X, Xue W, Zheng J, Tian P, Ding C. Cordycepin protects renal ischemia/reperfusion injury through regulating inflammation, apoptosis, and oxidative stress. Acta Biochim Biophys Sin (Shanghai). 2020 Feb 3;52(2):125-132. doi: 10.1093/abbs/gmz145.
- Background: PubMed 32398306Klok FA, Boon GJAM, Barco S, Endres M, Geelhoed JJM, Knauss S, Rezek SA, Spruit MA, Vehreschild J, Siegerink B. The Post-COVID-19 Functional Status scale: a tool to measure functional status over time after COVID-19. Eur Respir J. 2020 Jul 2;56(1):2001494. doi: 10.1183/13993003.01494-2020. Print 2020 Jul.
- Background: PubMed 35603810Sivan M, Preston N, Parkin A, Makower S, Gee J, Ross D, Tarrant R, Davison J, Halpin S, O'Connor RJ, Horton M. The modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) patient-reported outcome measure for Long Covid or Post-COVID-19 syndrome. J Med Virol. 2022 Sep;94(9):4253-4264. doi: 10.1002/jmv.27878. Epub 2022 Jun 1.
- 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.
Yibin Feng, Doctor principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese medicine nutritional supplement Cs4 in people with Long COVID, run by The University of Hong Kong 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 3 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 9 Jul 2024. 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?
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?
the change in symptom severity from 0 to 12 weeks measured by the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) (time frame: will be assessed at baseline and 12 weeks.). 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 NCT06054438, which also lists 6 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 9 Jul 2024.