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Examining the Function of Cs4 on Post-COVID-19 Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06054438
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Professor FENG Yibin, The University of Hong Kong

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Long COVID Other: Chinese medicine nutritional supplement Cs4 Phase 2

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

  1. Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
  2. The self-declared post-COVID-19 Functional Status scale should be at least over 1;
  3. The post-COVID symptoms have lasted at least 28 days after diagnosis;
  4. Currently not taking any other orally administered Chinese medicine;
  5. Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
  6. Voluntary participation in this clinical study. Exclusion Criteria

1. 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Group A- having treatment at first stage

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)

 Other: Chinese medicine nutritional supplement Cs4
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.
Group B- having treatment at secondstage

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)

 Other: Chinese medicine nutritional supplement Cs4
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the change in Insomnia Severity Index (ISI) from 0 to 12 weeks [ Time Frame: will be assessed at baseline and 12 weeks. ]
    To evaluate insomnia. Maximum values: 28, minimum values:0. Higher scores mean a worse outcome.

  2. the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks [ Time Frame: will be assessed at baseline and 12 weeks. ]
    To evaluate fatigue. Maximum values: 10, minimum values:0. Higher scores mean a worse outcome.

  3. the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks [ Time Frame: will be assessed at baseline and 12 weeks. ]
    To evaluate respiratory symptoms. Maximum values: 100, minimum values:0. Higher scores mean a worse outcome.

  4. the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks [ Time Frame: will be assessed at baseline and 12 weeks. ]
    To evaluate anxiety and depression. Maximum values: 21, minimum values:0. Higher scores mean a worse outcome.

  5. the change in Short Form 12 (SF12) from 0 to 12 weeks [ Time Frame: will be assessed at baseline and 12 weeks. ]
    To evaluate overall quality of life. Maximum values: 100, minimum values:0. Higher scores mean better physical and mental health functioning.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients with age from 18 to 75 years old, who have been previously diagnosed with COVID-19 and recovered;
  2. The self-declared post-COVID-19 Functional Status scale should be at least over 1;
  3. The post-COVID symptoms have lasted at least 28 days after diagnosis;
  4. Currently not taking any other orally administered Chinese medicine;
  5. Negative COVID-19 antigen or nucleic acid test within 3 days prior to signing the consent form;
  6. Voluntary participation in this clinical study.

Exclusion Criteria:

  1. 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.

Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054438


Contacts
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Contact: Yuanyuan Chen, MPhil 85262877807 loracyy@connect.hku.hk

Locations
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China
The School of Chinese Medicine, HKU Recruiting
Hong Kong, China, 00000
Contact: Van Szeto    39176475    vann@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yibin Feng, Doctor The University of Hong Kong
More Information
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Publications:

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Responsible Party: Professor FENG Yibin, Professor, Director, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT06054438    
Other Study ID Numbers: UW23-011
Innovation and Technology Fund ( Other Grant/Funding Number: PRP/069/22FX )
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Acute COVID-19 Syndrome
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Pathologic Processes