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

NCT06054438 | Completed DMC

• 2 other identifiers: UW23-011Innovation and Technology Fund
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• 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.

  will be assessed at baseline and 12 weeks.

Secondary Outcomes (5)

• the change in Insomnia Severity Index (ISI) from 0 to 12 weeks

  will be assessed at baseline and 12 weeks.

• the change in Brief Fatigue Inventory Form (BFI) from 0 to 12 weeks

  will be assessed at baseline and 12 weeks.

• the change in St. George's Respiratory Questionnaire (SGRQ) from 0 to 12 weeks

  will be assessed at baseline and 12 weeks.

• the change in Hospital Anxiety and Depression Scale (HADS) from 0 to 12 weeks

  will be assessed at baseline and 12 weeks.

• the change in Short Form 12 (SF12) from 0 to 12 weeks

  will be assessed at baseline and 12 weeks.

Study Arms (2)

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)

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)

Other: Chinese medicine nutritional supplement Cs4

Interventions

Chinese medicine nutritional supplement Cs4 OTHER

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 A- having treatment at first stage; Group B- having treatment at secondstage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to read and/or write Chinese or English;
• Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;
• \. Pregnant or lactating women; 5. Impaired hepatic or renal function.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The School of Chinese Medicine, HKU

Hong Kong, 00000, China

Location

Related Publications (6)

• 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.

  PMID: 32198918 BACKGROUND

• Garg 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.

  PMID: 34163217 BACKGROUND

• Chen 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.

  PMID: 32899766 BACKGROUND

• Han 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.

  PMID: 31951250 BACKGROUND

• Klok 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.

  PMID: 32398306 BACKGROUND

• Sivan 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.

  PMID: 35603810 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Yibin Feng, Doctor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 26, 2023
• Study Start: April 17, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)