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

Phase 2

• Conditions: Mild-to-moderate COVID-19
• Interventions: Drug: Oral Capsule

• Registration Number: NCT05157139
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-14
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-03
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (low dose)	Oral Capsule	Two capsules twice daily for 3 days then one capsule twice daily for 2 days
Intervention (high dose)	Oral Capsule	two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days

Primary Outcome Measures

Name	Time	Method
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. Rate of disease remission.	3-5 days	For mild/moderate symptoms patients: fever, cough and other symptoms relieved
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

Name	Time	Method
5. Mean change in C reactive protein (CRP)	3-5 days	CRP
9. The mean change in serum interleukin-6 (IL-6)	3-5 days	serum IL-6
4. Mean change in complete blood picture	3-5 days	CBC

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt