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

NCT05157139 | Unknown Phase 2 DMC

• 1 other identifier: 0106922
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild-to-moderate COVID-19

Keywords

mild-to-moderate COVID-19 vanillin, wheat germ oil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 4. Mean change in complete blood picture

  3-5 days

• 5. Mean change in C reactive protein (CRP)

  3-5 days

• 9. The mean change in serum interleukin-6 (IL-6)

  3-5 days

Study Arms (3)

Control

NO INTERVENTION

Patients receiving only standard care

Intervention (low dose)

ACTIVE COMPARATOR

Two capsules twice daily for 3 days then one capsule twice daily for 2 days

Drug: Oral Capsule

Intervention (high dose)

ACTIVE COMPARATOR

two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days

Drug: Oral Capsule

Interventions

Oral Capsule DRUG

Oral Capsule of vanillin \& wheat germ oil

Intervention (high dose); Intervention (low dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Alexandria University

Alexandria, 21521, Egypt

RECRUITING

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 14, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 31, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: up to March 2022

Locations

EG (1)