Mild-to-moderate COVID-19Phase 2/3NCT05157139
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 study testing Oral Capsule in people with Mild-to-moderate COVID-19, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild-to-moderate COVID-19
- What is being tested?
- Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria, 21521
Ahmed I ElMallah, PhD, +201001708794, ahmed.elmallah@alexu.edu.eg]
Ayman I Baess, PhD
About this study
- 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
- Being tested
- Oral Capsule
- Keywords
- mild-to-moderate COVID-19 vanillin, wheat germ oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral CapsuleDrug
Oral Capsule of vanillin \& wheat germ oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-5 days
2. Rate of disease remission.
For mild/moderate symptoms patients: fever, cough and other symptoms relieved
Measured: 3-5 days
3. Hospitaization & Survival rate
Comparing the influence of the intervention on the hospitalization \& Survival rate followed for up to 4 weeks.
Measured: up to 4 weeks
Secondary outcomes (3)
4. Mean change in complete blood picture
CBC
Measured: 3-5 days
5. Mean change in C reactive protein (CRP)
CRP
Measured: 3-5 days
9. The mean change in serum interleukin-6 (IL-6)
serum IL-6
Measured: 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Nov 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-to-moderate COVID-19Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam
- Responsible party
- Principal investigator, Ahmed Ibrahim ElMallah, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157139
- Sponsor's protocol ID
- 0106922
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share after results
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease
- ClinicalTrials.gov ID
- NCT05157139
- Acronym / sponsor ID
- 0106922
- Conditions
- Mild-to-moderate COVID-19
- Keywords
- mild-to-moderate COVID-19 vanillin, wheat germ oil
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receiving only standard care |
| Intervention (low dose) | Active comparator | Drug: Oral CapsuleTwo capsules twice daily for 3 days then one capsule twice daily for 2 days |
| Intervention (high dose) | Active comparator | Drug: Oral Capsuletwo capsules three times daily for 3 days, followed by one capsule three times daily for 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral CapsuleOral Capsule of vanillin \& wheat germ oil | Drug | Intervention (high dose), Intervention (low dose) |
Primary outcome
1. Mean change in the disease severity (clinical assessment).
Time frame: 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.
Time frame: 3-5 days
For mild/moderate symptoms patients: fever, cough and other symptoms relieved
3. Hospitaization & Survival rate
Time frame: up to 4 weeks
Comparing the influence of the intervention on the hospitalization \& Survival rate followed for up to 4 weeks.
3 secondary outcomes
4. Mean change in complete blood picture
Time frame: 3-5 days
5. Mean change in C reactive protein (CRP)
Time frame: 3-5 days
9. The mean change in serum interleukin-6 (IL-6)
Time frame: 3-5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Yes. The research team will share after results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral Capsule in people with Mild-to-moderate COVID-19, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Mean change in the disease severity (clinical assessment). (time frame: 3-5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.