Objectives:
We will evaluate the efficacy of standardized olive leaf capsules as additive therapy to the standard therapeutic regimen (for a period 10 days) on clinical symptoms, viral clearance, improvement of analysis:
1. Complete blood count (CBC).
2. C-Reactive Protein (CRP)
3. Lactate dehydrogenase (LDH).
4. Erythrocyte Sedimentation rate (ESR).
5. Serum Ferritin
6. D-dimer
7. Serum creatinine.
8. Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST).
9. Also, a 30-day mortality in patients with confirmed COVID-19, who are mild to moderately ill.
Trial design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial with a parallel-group design conducted at Fayoum university Hospital, Fayoum, Egypt.
Research Plan and Methodology 1-Complete patient history will be recorded (other diseases, current medications, age, sex, etc.) 2-Clinical investigation of patients by the physicians at Chest Department, Fayoum University Hospital including measurements such as Temperature and Oxygen saturation.
3-Patients will be tested for infection by PCR and all patients to be enrolled at the study should show positive PCR result.
4-The following analysis will be carried out for all the patients included in the study; CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST before treatment and for follow up after 10 days.
Participants:
All outpatients admitted to Chest Diseases Departments of Fayoum university Hospital, will be screened for the following criteria.
Inclusion criteria:
1. Adults.
2. Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
3. Mild to Moderate COVID-19 patients.
4. No history of the current use of olive leaf capsules supplement.
Exclusion criteria:
1. Severe and critical COVID-19 patients who need hospitalization.
2. Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
3. Patients showing any chronic disease (except hypertension and diabetes mellitus).
4. Patients who have multiorgan failure.
3\. Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
Intervention and comparator:
A total of 60 patients randomized into two groups (30 in each group). The patients will be divided into 2 groups Intervention group: All patients receive the standard treatment regimen for COVID-19, according to the Egyptian Ministry of Health protocol, along with 2-3 capsules/day of standardized olive leaf containing 20-50% oleuropein (500-750 mg oleuropein daily) for a period of ten days.
Control group: The standard therapeutic regimen for COVID-19 along with placebo capsules daily for a period of ten days.
Main outcomes:
The main outcomes are the improvement of clinical symptoms, as well as oxygen saturation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) within 10 days of randomization in patients with confirmed COVID-19, who are mild to moderately ill.
Randomization:
Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms.
Ethical considerations All participants should Sign informed consent and show willingness to accept randomization to any assigned treatment arm.
