Clinical trial NCT05552625: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: COVID-19
Antioxidative biomarker
Inflammatory biomarker
TADIOS
Lead sponsor: Helixmith Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female, aged between 18 to 65 years (both inclusive)
2. 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.
3. Patients who are hospitalized into designated hospital for COVID-19 treatment
4. Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19
5. 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).
6. Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study
7. Those who can comply with the requirements and processes in the clinical study
8. Women of childbearing age must be negative to urine pregnancy test during screening

Exclusion Criteria:

1. Patients with severe COVID-19
2. 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
3. Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding
4. Patients with cardiovascular, liver, cancer and kidney disease.
5. Self-reported patients being a recipient of immunosuppressive therapy
6. Self-reported patients who are allergic to this dietary supplements
7. 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
8. Patients who participated in another clinical trial within 1 month before screening
9. Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study
10. Patients consuming any herbal medicine
11. 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.

Primary outcomes:
measure: Evaluation of antioxidative and inflammatory Biomarkers
timeFrame: 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
measure: Clinical measurements - Ordinal Scale for COVID-19 Assessment
timeFrame: 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
measure: Clinical measurements - Clinical Recovery Scale for COVID-19 Assessment
timeFrame: Every day from screening till discharge and Day 14 after last IP administration
measure: Clinical measurements Clinical Improvement Scale for COVID-19 Assessment
timeFrame: Daily from screening to discharge or Day 14 after last IP administration
measure: Assessment of Quality of life - WHO-5 Well-Being Index
timeFrame: 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
measure: Assessment of Quality of life - Fatigue Severity Score
timeFrame: 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
measure: Hospitalization - Time to discharge
timeFrame: Day 1, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10)
Secondary outcomes:
measure: Safety and tolerability assessment after administration of TADIOS 1
timeFrame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
measure: Safety and tolerability assessment after administration of TADIOS - Hematology
timeFrame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
measure: Safety and tolerability assessment after administration of TADIOS - Serum Chemistry
timeFrame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
measure: Safety and tolerability assessment after administration of TADIOS - Urinalysis
timeFrame: Screening, Maximum Day 10 (The date of discharge or early termination, from Day 1 to Day 10) and Day 14 after last IP administration
measure: Safety and tolerability assessment after administration of TADIOS - Blood Pressure
timeFrame: 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
measure: Safety and tolerability assessment after administration of TADIOS - Body Temperature
timeFrame: 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
measure: Safety and tolerability assessment after administration of TADIOS - Pulse Rate
timeFrame: 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
measure: Safety and tolerability assessment after administration of TADIOS - Respiration Rate
timeFrame: 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
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Vagus Super Specialty Hospital
state: Karnataka
city: Bangalore
country: India
facility: Sparsh Superspeciality Hospital
state: Karnataka
city: Cochin
country: India
facility: Lakshmi Nursing Home
state: Kerala
city: Paravur
country: India
facility: Chaitanya Hospital
state: Kerala
city: Pune
country: India
facility: Gunjkar Multispeciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Oxycare Multispecialty Hospital
state: Maharashtra
Study officials:
affiliation: Sparsh Hospital
name: John M Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: