Back to resultsThe Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
TADIOS
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 focused on measuring COVID-19, Antioxidative biomarker, Inflammatory biomarker, TADIOS
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Vagus Super Specialty Hospital
- Sparsh Superspeciality Hospital
- Lakshmi Nursing Home
- Chaitanya Hospital
- Gunjkar Multispeciality Hospital
- Oxycare Multispecialty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TADIOS + Standard of care treatment
Placebo + Standard of care treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Evaluation of antioxidative and inflammatory Biomarkers
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
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 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
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
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
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
Duration of hospitalization
Time to discharge
Secondary Outcome Measures
Safety and tolerability assessment after administration of TADIOS 1
Subject incidence of Treatment-Emergent Adverse Events (TEAEs) and total number of unique TEAEs.
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.
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.
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.
Safety and tolerability assessment after administration of TADIOS - Blood Pressure
Change from baseline in Blood Pressure in mm Hg.
Safety and tolerability assessment after administration of TADIOS - Body Temperature
Change from baseline in Body Temperature ℃.
Safety and tolerability assessment after administration of TADIOS - Pulse Rate
Change from baseline in Pulse Rate in beats per minute.
Safety and tolerability assessment after administration of TADIOS - Respiration Rate
Change from baseline in Respiration Rate in breaths per minute.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05552625
Brief Title
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helixmith Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Antioxidative biomarker, Inflammatory biomarker, TADIOS
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TADIOS + Standard of care treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo + Standard of care treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TADIOS
Other Intervention Name(s)
Herbs
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose hydrate
Intervention Description
Combination of the following Lactose hydrate, Microcrystalline cellulose, Colloidal silicone dioxide, Povidone, Croscarmellose sodium, Magnesium stearate, Tabshield(79O245)
Primary Outcome Measure Information:
Title
Evaluation of antioxidative and inflammatory Biomarkers
Description
Change from baseline in Antioxidative and inflamatory biomarkers: TNF-α, CRP, IL-6, IL-1ra, Hb, and ferritin.
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
Title
Clinical measurements - Ordinal Scale for COVID-19 Assessment
Description
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.
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
Title
Clinical measurements - Clinical Recovery Scale for COVID-19 Assessment
Description
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).
Time Frame
Every day from screening till discharge and Day 14 after last IP administration
Title
Clinical measurements Clinical Improvement Scale for COVID-19 Assessment
Description
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).
Time Frame
Daily from screening to discharge or Day 14 after last IP administration
Title
Assessment of Quality of life - WHO-5 Well-Being Index
Description
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.
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
Title
Assessment of Quality of life - Fatigue Severity Score
Description
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.
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
Title
Hospitalization - Time to discharge
Description
Duration of hospitalization
Time to discharge
Time Frame
Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10)
Secondary Outcome Measure Information:
Title
Safety and tolerability assessment after administration of TADIOS 1
Description
Subject incidence of Treatment-Emergent Adverse Events (TEAEs) and total number of unique TEAEs.
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
Title
Safety and tolerability assessment after administration of TADIOS - Hematology
Description
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.
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
Title
Safety and tolerability assessment after administration of TADIOS - Serum Chemistry
Description
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.
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
Title
Safety and tolerability assessment after administration of TADIOS - Urinalysis
Description
Change from baseline in Urinalysis results: Color, pH, Specific gravity, albumin, bilirubin, glucose, urobilinogen, ketone, nitrite, hematuria, leukocyte and microscopy.
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
Title
Safety and tolerability assessment after administration of TADIOS - Blood Pressure
Description
Change from baseline in Blood Pressure in mm Hg.
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
Title
Safety and tolerability assessment after administration of TADIOS - Body Temperature
Description
Change from baseline in 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
Title
Safety and tolerability assessment after administration of TADIOS - Pulse Rate
Description
Change from baseline in Pulse Rate in beats per minute.
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
Title
Safety and tolerability assessment after administration of TADIOS - Respiration Rate
Description
Change from baseline in Respiration Rate in breaths per minute.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Paul, MD
Organizational Affiliation
Sparsh Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vagus Super Specialty Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560003
Country
India
Facility Name
Sparsh Superspeciality Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560022
Country
India
Facility Name
Lakshmi Nursing Home
City
Cochin
State/Province
Kerala
ZIP/Postal Code
683101
Country
India
Facility Name
Chaitanya Hospital
City
Paravur
State/Province
Kerala
ZIP/Postal Code
683513
Country
India
Facility Name
Gunjkar Multispeciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
4110019
Country
India
Facility Name
Oxycare Multispecialty Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411033
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19
We'll reach out to this number within 24 hrs