Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease

Alexandria University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Mild-to-moderate COVID-19

Treatments: Drug: Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05157139

0106922

Details and patient eligibility

About

• The study is a randomized clinical trial to assess a natural formula of vanillin & wheat germ oil to treat and stop the clinical progression of COVID-19.
• The study aims to treat people with mild-to-moderate COVID-19 before their cases become severe.
• The study duration is a 5-day experimental intervention and an extended 4 weeks follow up.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. PCR confirmed diagnosis for COVID-19.
2. Age ≥18 years.
3. Both genders
4. The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration.
5. Patients diagnosed as mild or moderate

Exclusion criteria

1. Patients diagnosed with severe Illness: Individuals who have SpO2 <92% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%.
2. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases.
3. Allergy to Vanilla flavor, vanillin, or wheat germ oil
4. Active cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Control

No Intervention group

Description:

Patients receiving only standard care

Intervention (low dose)

Active Comparator group

Description:

Two capsules twice daily for 3 days then one capsule twice daily for 2 days

Treatment:

Drug: Oral Capsule

Intervention (high dose)

Active Comparator group

Description:

two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days

Treatment:

Drug: Oral Capsule