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

• 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.

Study Overview

• Status: Recruiting
• Conditions: Mild-to-moderate COVID-19
• Intervention / Treatment: Drug: Oral Capsule

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Recruiting
    • Alexandria University
    • Contact: Ahmed I ElMallah, PhD; Phone Number: +201001708794; Email: ahmed.elmallah@alexu.edu.eg]
    • Principal Investigator: Ayman I Baess, PhD
    • Principal Investigator: Noha A Hamdy, PhD
    • Principal Investigator: Hanya H Sweilam, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: mild-to-moderate COVID-19 vanillin, wheat germ oil
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Virus Diseases
• Other Study ID Numbers: 0106922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The research team will share after results
• IPD Sharing Time Frame: up to March 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No