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

Mild-to-moderate COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157139
• Other study ID #: 0106922
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2021
• Est. completion date: April 2022

Study information

• Verified date: December 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mild-to-moderate COVID-19
• Virus Diseases

Intervention

Drug:
• Oral Capsule
Oral Capsule of vanillin & wheat germ oil

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (4)

Lead Sponsor	Collaborator
Alexandria University	Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	2. Rate of disease remission.	For mild/moderate symptoms patients: fever, cough and other symptoms relieved	3-5 days
Primary	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	4. Mean change in complete blood picture	CBC	3-5 days
Secondary	5. Mean change in C reactive protein (CRP)	CRP	3-5 days
Secondary	9. The mean change in serum interleukin-6 (IL-6)	serum IL-6	3-5 days