Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000273583
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
18/03/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of SRS-MHT-44 against Long COVID in Adults Aged 18-65 Years.
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of SRS-MHT-44 against Long COVID in Adults Aged 18-65 Years.
Secondary ID [1] 310547 0
None
Universal Trial Number (UTN)
U1111-1297-5454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 331375 0
Condition category
Condition code
Alternative and Complementary Medicine 328119 328119 0 0
Herbal remedies
Inflammatory and Immune System 328120 328120 0 0
Other inflammatory or immune system disorders
Infection 328121 328121 0 0
Other infectious diseases
Neurological 329610 329610 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Herbal formula (SHR-MHT-44) (15mls taken orally, three times daily (approximately 4 to 6hrs apart) with or without food, delivering 45 mls a day for 8 weeks). Adherence to liquid intake will be measured by bottle returns at weeks 4 and 8.
Intervention code [1] 326939 0
Treatment: Other
Comparator / control treatment
A placebo liquid containing no herbal ingredients but matching in appearance and containing distilled water, saline solution (isotonic, 0.9%), glycerin, caramel colour, and flavouring
Control group
Placebo

Outcomes
Primary outcome [1] 335995 0
Investigator-Initiated Visual Analogue Scale (VAS): Weighted Total score
Timepoint [1] 335995 0
Day 0 (pre-commencement of intervention), 31, and 61 (primary endpoint) post-intervention commencement
Primary outcome [2] 335996 0
Investigator-Initiated Health-Related Quality of Life (HRQoL): Weighted Total score
Timepoint [2] 335996 0
Day 0 (pre-commencement of intervention), 31, and 61 (primary endpoint) post-intervention commencement
Secondary outcome [1] 426397 0
Investigator-Initiated VAS Neurological subscale score
Timepoint [1] 426397 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [2] 426398 0
Investigator-Initiated VAS Respiratory subscale score
Timepoint [2] 426398 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [3] 426399 0
Investigator-Initiated VAS Cardiological subscale score
Timepoint [3] 426399 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [4] 426400 0
Investigator-Initiated VAS Muscular subscale score
Timepoint [4] 426400 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [5] 426401 0
Investigator-Initiated VAS Emotional/ Psychological subscale score
Timepoint [5] 426401 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [6] 426402 0
Investigator-Initiated VAS General subscale score
Timepoint [6] 426402 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [7] 426403 0
Investigator-Initiated HRQoL Neurological Subscale score
Timepoint [7] 426403 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [8] 426404 0
Investigator-Initiated HRQoL Self-care Subscale score
Timepoint [8] 426404 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [9] 426405 0
Investigator-Initiated HRQoL Mobility Subscale score
Timepoint [9] 426405 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [10] 426406 0
Investigator-Initiated HRQoL Emotion/ Mood Subscale score
Timepoint [10] 426406 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [11] 426407 0
Investigator-Initiated HRQoL General Subscale score
Timepoint [11] 426407 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [12] 426408 0
Investigator-Initiated HRQoL Work Subscale score
Timepoint [12] 426408 0
Day 0 (pre-commencement of intervention), 31, and 61 post-intervention commencement
Secondary outcome [13] 426409 0
Change in blood inflammatory markers comprising mean percentage change in blood concentrations of C-reactive protein and Procalcitonin (composite measure via a blood test)
Timepoint [13] 426409 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [14] 426410 0
Change in cardiac-related markers comprising mean percentage change in blood concentrations of Troponin, D-Dimer, Brain Natriuretic Peptide, and N-terminal pro-hormone BNP (composite measure)
Timepoint [14] 426410 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [15] 426411 0
Change in Renal/Liver/Bone-related blood markers comprising mean percentage change in blood concentrations of creatinine, albumin, and bone alkaline phosphatase (composite measure via a blood test)
Timepoint [15] 426411 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [16] 426412 0
Change in respiratory/ endurance-related markers comprising mean percentage change in blood concentrations of complete blood count and ferritin (composite measure via a blood test)
Timepoint [16] 426412 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [17] 426413 0
Change in immune-related blood markers comprising mean percentage change in blood concentrations of Lymphocytes T (CD3) and B (CD19) subpopulations, CD4/CD8 ratio, and IgG and IgM antibodies against SARS-CoV-2 (composite measure via a blood test)
Timepoint [17] 426413 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [18] 426414 0
Change in blood concentrations of Glycosylated Haemoglobin (via a blood test)
Timepoint [18] 426414 0
Day 0 (pre-commencement of intervention) and 61 post-intervention commencement
Secondary outcome [19] 431670 0
Patient-Abridged VAS: Weighted Total score (exploratory measure)
Timepoint [19] 431670 0
Day 15 and 45 post-intervention commencement
Secondary outcome [20] 431671 0
Patient-Abridged HRQoL: Weighted Total score (exploratory measure)
Timepoint [20] 431671 0
Day 15 and 45 post-intervention commencement
Secondary outcome [21] 431673 0
Pulse Oximeter Score (exploratory measure)
Timepoint [21] 431673 0
Day 0 (pre-commencementof intervention), 31, and 61 post-intervention commencement

Eligibility
Key inclusion criteria
1) Adults aged between 18 and 65 years.

2) Participants have an adequate understanding of the clinical research, agree to follow study procedures, and provide an autonomously signed informed consent.

3) BMI between 18.5 and 30 kg/m2

4) Diagnosis or evidence of Long COVID comprising:
a. An initial documented COVID-19 infection (positive Rapid Antigen Test/RT-PCR during acute infection, or clinical diagnosis by a doctor during or after acute illness) and for at least 3 months (greater than or equal to 12 weeks) prior to Screening, and
b. A negative result on a COVID-19 rapid antigen test at the first in-person assessment, and
c. Symptoms must have developed only after initial COVID infection, and
d. Symptoms must be experienced for at least 3 months (greater than or equal to 12 weeks) after the initial COVID-19 infection, and
e. After the telephone interview, the reported presence of at least 2 or more symptoms from 3 or more categories below

MUSCULAR (CATEGORY 1)
• Muscle aches and pains
• Muscle weakness (e.g. don’t feel as strong physically, more effort than normal required for physical tasks or movement)
• Impaired mobility (e.g. difficulty walking, legs struggling to support body weight)
• Pain in joints

RESPIRATORY (CATEGORY 2)
• Coughing
• Sneezing
• Breathing difficulties (e.g. physically struggle to exhale, throat feels like it is closing up/squeezing sensation)
• Shortness of breath? (e.g. can’t get enough air, feels like you’ve been running or after heavy exertion)
• Lightheaded
• Shallow breathing

NEUROLOGICAL (CATEGORY 3)
• Headache
• Brain fog or signs of uncharacteristic ‘slowness’ or confusion (cognitive impairment)
• Difficulty concentrating or focusing on a task
• Gaps in short-term memory/being more forgetful than usual
• Difficulty recalling information
• Restlessness
• Fatigue
• Lack of energy and endurance
• Lethargy
• Easily get tired/exhaust yourself
• Difficulty falling asleep/insomnia
• Broken/interrupted sleep
• Unsatisfying sleep
• Cannot switch off your mind/racing thoughts
• Trouble maintaining balance
• Shooting nerve pain (neuropathy)
• Visual disturbances or impaired vision post-infection

CARDIOLOGICAL (CATEGORY 4)
• Chest pain and/or tight chest
• Fast heartbeat/pounding heart
• Heart palpations
• Poor blood circulation
• Feeling cold (e.g. chills, cold hands and feet)
• Dizziness
• Pins and needles
• ‘Heavy’ legs

EMOTIONAL/PSYCHOLOGICAL (CATEGORY 5)
• Low mood
• Irritability
• Anxiety
• Nervousness
• Easily moved to tears
• Feelings of frustration
• Feelings of helplessness
• Depression
• Worry

GENERAL (CATEGORY 6)
• Ongoing changes to sense of smell and taste
• Loss of appetite
• Weight loss
• General malaise/feeling unwell
• Flare-ups of old disease symptoms (e.g. latent viral infection) and/or inflammation of old injuries
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Active COVID-19 infection at visit 1 as evidenced by:
a. A positive COVID-19 rapid antigen test (RAT) at visit 1
b. Medical evaluation confirming the presence of a body temperature greater than or equalt to 38ºC, and/or the onset of recent symptoms indicative of acute COVID-19 infection, including but not limited to a sore throat, runny nose, and loss of taste or smell.

2) Serious medical conditions that could introduce confounding in the interpretation of the treatment effect, or any serious medical condition that, in the opinion of the investigators, could complicate proper interpretation of the symptomatology as being of Long COVID. This includes, but is not limited to, the following:
a. Cancer
b. Diabetes (type I/insulin-dependent)
c. Chronic Obstructive Pulmonary Disease (COPD) Stage II (moderate) or higher
d. Chronic kidney disease (CDK Stage 3 or higher)
e. Heart failure (NYHA Class II or higher)
f. Autoimmune conditions

3) Participants with a non-serious illness but unstable condition as evidenced by:
a. ECOG Performance Status greater than 2
b. Illness requiring hospitalisation in the last 3 months
c. Therapeutic regimen has been inconsistent and irregular within the last 3 months
d. Foreseeable evolution of the illness during the trial period will require treatment changes

4) Women who are pregnant or breastfeeding

5) Recently received a COVID-19 vaccine or booster or any other treatment for active/Long COVID in the last 30 days, or intend to do so during the study period.

6) Received any blood, plasma products or immunoglobulins within the past 60 days or intend to do so during the study period.

7) Received any immunosuppressive treatments within the past 90 days or intend to do so during the study period.

8) Taken part in other interventional studies within the last 90 days, or intend to do so during the course of the present study.

9) Have any surgery or treatments scheduled during the study period that, in the opinion of the researcher, may compromise adherence to the study

10) History of allergic reactions or hypersensitivity to the ingredients in the experimental product or placebo.

11) Currently taking, or recently changed, herbal and nutraceutical supplements reasonably expected to influence study measures.

12) Current smoker or heavy smoker in the last 3 years

13) A history of excessive alcohol consumption and/or drug abuse in the last 12 months

14) Planned major lifestyle change in the next 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Permuted block randomisation using a randomisation table created by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2024
Actual
5/07/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
120
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314750 0
Commercial sector/Industry
Name [1] 314750 0
SRS BioScience of Longevity Ltd
Country [1] 314750 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 316731 0
Commercial sector/Industry
Name [1] 316731 0
SRS BioScience of Longevity Ltd
Address [1] 316731 0
15 St. Benedicts Street, Newton, Auckland 1010
Country [1] 316731 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313759 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 313759 0
Ethics committee country [1] 313759 0
Australia
Date submitted for ethics approval [1] 313759 0
10/11/2022
Approval date [1] 313759 0
08/08/2023
Ethics approval number [1] 313759 0
0116E_2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129270 0
Dr Adrian Lopresti
Address 129270 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 129270 0
Australia
Phone 129270 0
+61 8 94487376
Fax 129270 0
Email 129270 0
[email protected]
Contact person for public queries
Name 129271 0
Adrian Lopresti
Address 129271 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 129271 0
Australia
Phone 129271 0
+61 8 94487376
Fax 129271 0
Email 129271 0
[email protected]
Contact person for scientific queries
Name 129272 0
Adrian Lopresti
Address 129272 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 129272 0
Australia
Phone 129272 0
+61 8 94487376
Fax 129272 0
Email 129272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.