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Status unknownNCT05157139Updated Jan 31, 2022

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

A Phase 2/3 interventional study of Oral Capsule in Mild-to-moderate COVID-19, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Alexandria University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Mild-to-moderate COVID-19

Keywords

  • mild-to-moderate COVID-19 vanillin, wheat germ oil
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugOral Capsule

    Oral Capsule of vanillin \& wheat germ oil

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3-5 days

  2. 2. Rate of disease remission.

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

    Time frame: 3-5 days

  3. 3. Hospitaization & Survival rate

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

    Time frame: up to 4 weeks

Secondary outcomes

  1. 4. Mean change in complete blood picture

    CBC

    Time frame: 3-5 days

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

    CRP

    Time frame: 3-5 days

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

    serum IL-6

    Time frame: 3-5 days

07

Study locations

1 of 1 sites recruiting
  • Alexandria University
    Alexandria, 21521, Egypt
    • Ahmed I ElMallah, PhD · Contact · ahmed.elmallah@alexu.edu.eg] · +201001708794
    • Ayman I Baess, PhD · Principal investigator
    • Noha A Hamdy, PhD · Principal investigator
    • Hanya H Sweilam, Bachelor · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The research team will share after results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05157139
Lead sponsor
Alexandria University
Collaborators
Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam
Responsible party
Ahmed Ibrahim ElMallah (Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University, Alexandria University) — Principal investigator
First posted
Dec 14, 2021
Start date
Nov 1, 2021
Primary completion
Mar 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Jan 31, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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