Mild-to-moderate COVID-19
Conditions
Keywords
mild-to-moderate COVID-19 vanillin, wheat germ oil
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.
Interventions
Oral Capsule of vanillin & wheat germ oil
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 4. Mean change in complete blood picture | 3-5 days | CBC |
| 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 |
Countries
Egypt