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

Primary Purpose

Mild-to-moderate COVID-19

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Oral Capsule

About this trial

This is an interventional treatment trial for Mild-to-moderate COVID-19 focused on measuring mild-to-moderate COVID-19 vanillin, wheat germ oil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention (low dose)

Intervention (high dose)

Arm Description

Patients receiving only standard care

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

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

Outcomes

Primary Outcome Measures

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

2. Rate of disease remission.

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

3. Hospitaization & Survival rate

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

Secondary Outcome Measures

4. Mean change in complete blood picture

CBC

5. Mean change in C reactive protein (CRP)

CRP

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

serum IL-6

Full Information

NCT ID

NCT05157139

First Posted

December 10, 2021

Last Updated

January 17, 2022

Sponsor

Alexandria University

Collaborators

Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam

1. Study Identification

Unique Protocol Identification Number

NCT05157139

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

Collaborators

Assoc. Prof. Ayman Ibrahim Baess, Dr. Noha Alaa Eldine Hassan Hamdy, Ph. Hanya Hesham Sweilam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild-to-moderate COVID-19

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients receiving only standard care

Arm Title

Intervention (low dose)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intervention (high dose)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oral Capsule

Intervention Description

Oral Capsule of vanillin & wheat germ oil

Primary Outcome Measure Information:

Title

1. Mean change in the disease severity (clinical assessment).

Description

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

Title

2. Rate of disease remission.

Description

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

Time Frame

3-5 days

Title

3. Hospitaization & Survival rate

Description

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

Time Frame

up to 4 weeks

Secondary Outcome Measure Information:

Title

4. Mean change in complete blood picture

Description

CBC

Time Frame

3-5 days

Title

5. Mean change in C reactive protein (CRP)

Description

CRP

Time Frame

3-5 days

Title

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

Description

serum IL-6

Time Frame

3-5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Alexandria University

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed I ElMallah, PhD

Phone

+201001708794

ahmed.elmallah@alexu.edu.eg]

First Name & Middle Initial & Last Name & Degree

Ayman I Baess, PhD

First Name & Middle Initial & Last Name & Degree

Noha A Hamdy, PhD

First Name & Middle Initial & Last Name & Degree

Hanya H Sweilam, Bachelor

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The research team will share after results

IPD Sharing Time Frame

up to March 2022

Learn more about this trial

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

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