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

• Sponsor: Alexandria University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05157139
• Collaborator: Assoc. Prof. Ayman Ibrahim Baess (Other), Dr. Noha Alaa Eldine Hassan Hamdy (Other), Ph. Hanya Hesham Sweilam (Other)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 24.2

Study Details

Study Description

Brief Summary

• 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.

Condition or Disease	Intervention/Treatment	Phase
Mild-to-moderate COVID-19	Drug: Oral Capsule	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 1. Mean change in the disease severity (clinical assessment). [3-5 days]

   Time taken for the changes from moderate or mild or complete recovery/FDA assessment of key COVID-19-related symptoms score

2. 2. Rate of disease remission. [3-5 days]

   For mild/moderate symptoms patients: fever, cough and other symptoms relieved

3. 3. Hospitaization & Survival rate [up to 4 weeks]

   Comparing the influence of the intervention on the hospitalization & Survival rate followed for up to 4 weeks.

Secondary Outcome Measures

1. 4. Mean change in complete blood picture [3-5 days]

   CBC

2. 5. Mean change in C reactive protein (CRP) [3-5 days]

   CRP

3. 9. The mean change in serum interleukin-6 (IL-6) [3-5 days]

   serum IL-6

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University	Alexandria		Egypt	21521

Sponsors and Collaborators

• Alexandria University
• Assoc. Prof. Ayman Ibrahim Baess
• Dr. Noha Alaa Eldine Hassan Hamdy
• Ph. Hanya Hesham Sweilam

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Ibrahim ElMallah, Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University, Alexandria University
• ClinicalTrials.gov Identifier: NCT05157139
• Other Study ID Numbers: 0106922
• First Posted: Dec 14, 2021
• Last Update Posted: Jan 31, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Ibrahim ElMallah, Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University, Alexandria University: mild-to-moderate COVID-19 vanillin, wheat germ oil
• Additional relevant MeSH terms: COVID-19; Virus Diseases

Study Results

No Results Posted as of Jan 31, 2022