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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild-to-moderate COVID-19

Intervention / Treatment
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* Drug: Oral Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCR confirmed diagnosis for COVID-19. Age ≥18 years. Both genders The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration. Patients diagnosed as mild or moderate Exclusion Criteria: 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%. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases. Allergy to Vanilla flavor, vanillin, or wheat germ oil Active cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients receiving only standard care | |
| Active Comparator: Intervention (low dose)<br>Two capsules twice daily for 3 days then one capsule twice daily for 2 days | Drug: Oral Capsule<br>* Oral Capsule of vanillin & wheat germ oil<br>|
| Active Comparator: Intervention (high dose)<br>two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days | Drug: Oral Capsule<br>* Oral Capsule of vanillin & wheat germ oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Mean change in the disease severity (clinical assessment). | Time taken for the changes from moderate or mild or complete recovery/FDA assessment of key COVID-19-related symptoms score | 3-5 days | 
| 2. Rate of disease remission. | For mild/moderate symptoms patients: fever, cough and other symptoms relieved | 3-5 days | 
| 3. Hospitaization & Survival rate | Comparing the influence of the intervention on the hospitalization & Survival rate followed for up to 4 weeks. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4. Mean change in complete blood picture | CBC | 3-5 days | 
| 5. Mean change in C reactive protein (CRP) | CRP | 3-5 days | 
| 9. The mean change in serum interleukin-6 (IL-6) | serum IL-6 | 3-5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild-to-moderate COVID-19 vanillin, wheat germ oil