Cordyceps is a medicinal Chinese medicine. The benefits of cordyceps-related therapeuticaction 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 Cs4is a Chinese medicine nutritional supplement fermented by Cordyceps. This Projectconducts a two-stage waitlist-controlled trial to examine the therapeutic effect of theCs4 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 Awill have treatment while group B will have no Cs4 treatment. In the second-stageclinical trial for 12 weeks, group A will have no Cs4 treatment while group B will haveCs4 treatment. A 12-week follow-up will be conducted after the intervention of Cs4 forgroup A. The primary outcome will be the change from 0 to 12 weeks in symptom severitymeasured by self-declared modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm). Inour study, we intend to analyse the efficacy of Cs4 on the improvement of long Covidsymptoms by using a comprehensive measurement to cover most symptoms, and becondition-specific. The secondary outcomes will include the change from 0 to 12 weeks ofInsomnia Severity Index (ISI), Brief Fatigue Inventory Form, St. George's RespiratoryQuestionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), and the Short Form 12(SF12). Blood tests will be assessed for safety study. primary outcomes and secondaryoutcomes will be assessed at baseline (week 0) and week 12. The anticipated outcome ofthe study is to provide evidence of Cs4 in the improvement of long COVID symptoms. Thisproject can serve to the development of a nutritional supplement for the management ofpost-COVID-related health problems.
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.
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.
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.
The School of Chinese Medicine, HKU
Hong Kong 1819729, China
Yibin Feng, Doctor, Principal Investigator
The University of Hong Kong