The Efficacy and Safety of TADIOS as an Adjuvant Therapy in Patients Diagnosed With Mild to Moderate COVID-19

Helixmith

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: TADIOS; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552625

21PR0041-008

Details and patient eligibility

About

This study will assess the safety and efficacy and tolerability of TADIOS compared to placebo in patients with mild to moderate COVID-19.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

TADIOS + Standard of care treatment

Active Comparator group

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.

Treatment:

Drug: TADIOS

Placebo + Standard of care treatment

Placebo Comparator group

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.

Treatment:

Drug: Placebo