COVID-19Phase 2/3NCT05552625
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
A Phase 2/3 study testing TADIOS in people with COVID-19, run by Helixmith Co., Ltd. at 6 sites in India.
Trial summary
This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo in patients with mild to moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- TADIOS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesIndia
- Study dates
- 6 May 2021to 24 Feb 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, aged between 18 to 65 years (both inclusive)
- Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
- Patients who are hospitalized into designated hospital for COVID-19 treatment
- Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
- Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.
- Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache. The elderly may present with atypical symptoms. These patients do not have any signs of dehydration, sepsis or shortness of breath.
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- Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects).
- Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study
- Those who can comply with the requirements and processes in the clinical study
- Women of childbearing age must be negative to urine pregnancy test during screening
Who cannot join
- Patients with severe COVID-19
- Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigator's judgment
- Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
- Patients with cardiovascular, liver, cancer and kidney disease.
- Self-reported patients being a recipient of immunosuppressive therapy
- Self-reported patients who are allergic to this dietary supplements
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- Patients taking a health functional food or medicine that may affect the body's antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit
- Patients who participated in another clinical trial within 1 month before screening
- Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study
- Patients consuming any herbal medicine
- Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes). Menopause refers to 1 year of no menstruation.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Vagus Super Specialty Hospital
Bangalore, Karnataka, 560003
Sparsh Superspeciality Hospital
Bangalore, Karnataka, 560022
Lakshmi Nursing Home
Kochi, Kerala, 683101
Chaitanya Hospital
Paravūr, Kerala, 683513
Gunjkar Multispeciality Hospital
Pune, Maharashtra, 4110019
Oxycare Multispecialty Hospital
Pune, Maharashtra, 411033
About this study
Official title: Multicenter, Double-blind, Placebo-controlled, Maximum 10 Days Administration Study to Evaluate the Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo in patients with mild to moderate COVID-19.
Read the detailed description
100 patients diagnosed with COVID-19 by RT-PCR were randomized in a ratio of 1:1 into TADIOS group and placebo group to evaluate efficacy and safety after intake over 10 days.
- Conditions
- COVID-19
- Being tested
- TADIOS, Placebo
- Keywords
- COVID-19, Antioxidative biomarker, Inflammatory biomarker, TADIOS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TADIOSDrug
Also called Herbs
TADIOS is a combination extract which composed of three herbs, and each herbal medicine has been traditionally used as a food or a herbal medicine treating various respiratory diseases in Asia
PlaceboDrug
Also called Lactose hydrate
Combination of the following Lactose hydrate, Microcrystalline cellulose, Colloidal silicone dioxide, Povidone, Croscarmellose sodium, Magnesium stearate, Tabshield(79O245)
| Study group | Role | What they receive |
|---|---|---|
| TADIOS + Standard of care treatment | Active comparator | 4 tablets of 300 mg each will be administered to the subjects twice daily (1200 mg in the morning and 1200mg in the evening making it 2400 mg/day) for a maximum of 10 days. The subject can consume standard of care treatment as per prescribed by the physician. Receives: Drug: TADIOS |
| Placebo + Standard of care treatment | Placebo comparator | 4 tablets of 300 mg each will be administered to the subjects twice daily (1200 mg in the morning and 1200mg in the evening making it 2400 mg/day) for a maximum of 10 days. The subject can consume standard of care treatment as per prescribed by the physician. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of antioxidative and inflammatory Biomarkers
Change from baseline in Antioxidative and inflamatory biomarkers: TNF-α, CRP, IL-6, IL-1ra, Hb, and ferritin.
Measured: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Clinical measurements - Ordinal Scale for COVID-19 Assessment
Change from baseline in Covid-19 8-point Ordinal Scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death.
Measured: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Clinical measurements - Clinical Recovery Scale for COVID-19 Assessment
Time to clinical recovery in COVID-19 Clinical Symptom Scale: The clinical symptom scale has been designed for this study to access the clinical state and time taken to relieve the clinical symptoms of COVID-19 (fever, dry cough, tiredness, aches and pains, sore throat, diarrhea, headache, loss of taste, loss of smell, difficulty in breathing or shortness of breath and chest pain or pressure).
Measured: Every day from screening till discharge and Day 14 after last IP administration
Clinical measurements Clinical Improvement Scale for COVID-19 Assessment
Proportion of Clinical Improvement in Clinical Symptom Scale (Count of subjects with and without a symptom by treatment group on each day with the previous day counts during the study period).
Measured: Daily from screening to discharge or Day 14 after last IP administration
Assessment of Quality of life - WHO-5 Well-Being Index
Change from baseline in WHO-5 Well-Being Index: The total raw score, ranging from 0 to 25, will be multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Assessment of Quality of life - Fatigue Severity Score
Change from baseline in Fatigue Severity Score: Minimum total score possible is nine and the maximum is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Measured: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Hospitalization - Time to discharge
- Duration of hospitalization
- Time to discharge
Measured: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10)
Secondary outcomes (8)
Safety and tolerability assessment after administration of TADIOS 1
Subject incidence of Treatment-Emergent Adverse Events (TEAEs) and total number of unique TEAEs.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Hematology
Change from baseline in Hematology, Complete Blood Count results WBC, RBC, Hb, HCT, MCV, MCH, MCHC, PLT, MPV, differential count of WBC (Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil), and ESR.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Serum Chemistry
Change from baseline in Serum Chemistry results: total protein, albumin, globulin, A/G ratio, total bilirubin, AST, ALT, GGT, Random glucose, BUN, creatinine, estimated GFR, Ca2+, phosphate, Na+, K+, Cl-, CRP, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Urinalysis
Change from baseline in Urinalysis results: Color, pH, Specific gravity, albumin, bilirubin, glucose, urobilinogen, ketone, nitrite, hematuria, leukocyte and microscopy.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Blood Pressure
Change from baseline in Blood Pressure in mm Hg.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Body Temperature
Change from baseline in Body Temperature ℃.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Pulse Rate
Change from baseline in Pulse Rate in beats per minute.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Respiration Rate
Change from baseline in Respiration Rate in breaths per minute.
Measured: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start6 May 2021 (estimated)
- Primary completion24 Feb 2022 (estimated)
- Study completion24 Feb 2022 (estimated)
Why it stopped: This Phase I study was conducted in India and no subject data was provided to sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helixmith Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John M Paul, MD, Principal investigator, Sparsh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552625
- Sponsor's protocol ID
- 21PR0041-008
- Status last verified
- Aug 2025
- First submitted
- 20 Apr 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Placebo-controlled, Maximum 10 Days Administration Study to Evaluate the Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05552625
- Acronym / sponsor ID
- 21PR0041-008
- Conditions
- COVID-19
- Keywords
- COVID-19, Antioxidative biomarker, Inflammatory biomarker, TADIOS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This Phase I study was conducted in India and no subject data was provided to sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helixmith Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2021 (estimated)
- Primary completion
- 24 Feb 2022 (estimated)
- Study completion
- 24 Feb 2022 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo in patients with mild to moderate COVID-19.
Detailed description
100 patients diagnosed with COVID-19 by RT-PCR were randomized in a ratio of 1:1 into TADIOS group and placebo group to evaluate efficacy and safety after intake over 10 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TADIOS + Standard of care treatment | Active comparator | Drug: TADIOS4 tablets of 300 mg each will be administered to the subjects twice daily (1200 mg in the morning and 1200mg in the evening making it 2400 mg/day) for a maximum of 10 days. The subject can consume standard of care treatment as per prescribed by the physician. |
| Placebo + Standard of care treatment | Placebo comparator | Drug: Placebo4 tablets of 300 mg each will be administered to the subjects twice daily (1200 mg in the morning and 1200mg in the evening making it 2400 mg/day) for a maximum of 10 days. The subject can consume standard of care treatment as per prescribed by the physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or Female, aged between 18 to 65 years (both inclusive)
- Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples.
- Patients who are hospitalized into designated hospital for COVID-19 treatment
- Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
- Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India.
Key exclusion criteria (11 listed)
- Patients with severe COVID-19
- Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigator's judgment
- Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
- Patients with cardiovascular, liver, cancer and kidney disease.
- Self-reported patients being a recipient of immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TADIOSAlso: HerbsTADIOS is a combination extract which composed of three herbs, and each herbal medicine has been traditionally used as a food or a herbal medicine treating various respiratory diseases in Asia | Drug | TADIOS + Standard of care treatment |
| PlaceboAlso: Lactose hydrateCombination of the following Lactose hydrate, Microcrystalline cellulose, Colloidal silicone dioxide, Povidone, Croscarmellose sodium, Magnesium stearate, Tabshield(79O245) | Drug | Placebo + Standard of care treatment |
Primary outcome
Evaluation of antioxidative and inflammatory Biomarkers
Time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Change from baseline in Antioxidative and inflamatory biomarkers: TNF-α, CRP, IL-6, IL-1ra, Hb, and ferritin.
Clinical measurements - Ordinal Scale for COVID-19 Assessment
Time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Change from baseline in Covid-19 8-point Ordinal Scale: 0 = Uninfected, 1 = Ambulatory without limitation of activity, 2 = Ambulatory with limitation of activity, 3 = Hospitalized mild disease, no oxygen, 4 = Hospitalized mild disease, supplemental oxygen, 5 = Hospitalized severe disease, non-invasive ventilation or high-flow oxygen, 6 = Hospitalized severe disease, intubation and mechanical ventilation, 7 = Hospitalized severe disease, ventilation plus additional organ support, 8 = Death.
Clinical measurements - Clinical Recovery Scale for COVID-19 Assessment
Time frame: Every day from screening till discharge and Day 14 after last IP administration
Time to clinical recovery in COVID-19 Clinical Symptom Scale: The clinical symptom scale has been designed for this study to access the clinical state and time taken to relieve the clinical symptoms of COVID-19 (fever, dry cough, tiredness, aches and pains, sore throat, diarrhea, headache, loss of taste, loss of smell, difficulty in breathing or shortness of breath and chest pain or pressure).
Clinical measurements Clinical Improvement Scale for COVID-19 Assessment
Time frame: Daily from screening to discharge or Day 14 after last IP administration
Proportion of Clinical Improvement in Clinical Symptom Scale (Count of subjects with and without a symptom by treatment group on each day with the previous day counts during the study period).
Assessment of Quality of life - WHO-5 Well-Being Index
Time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Change from baseline in WHO-5 Well-Being Index: The total raw score, ranging from 0 to 25, will be multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Assessment of Quality of life - Fatigue Severity Score
Time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Change from baseline in Fatigue Severity Score: Minimum total score possible is nine and the maximum is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
Hospitalization - Time to discharge
Time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10)
1. Duration of hospitalization 2. Time to discharge
8 secondary outcomes
Safety and tolerability assessment after administration of TADIOS 1
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Hematology
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Serum Chemistry
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Urinalysis
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Blood Pressure
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Body Temperature
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Pulse Rate
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Safety and tolerability assessment after administration of TADIOS - Respiration Rate
Time frame: Screening, Maximum Day 10 (The date of discharge or early termination, at Day 1, 2, 4, 7, 10) and Day 14 after last IP administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Paul, MD principal investigator
Sparsh Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TADIOS in people with COVID-19, run by Helixmith Co., Ltd. at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of antioxidative and inflammatory Biomarkers (time frame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.