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

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.

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;
• Inability to communicate (e.g. with cognitive impairment) 3. Allergy to Cordyceps sinensis;

• Pregnant or lactating women; 5. Impaired hepatic or renal function.