Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of COVID-19 Patients
Assessment of the Clinical Effectiveness of Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of Non-hospitalized COVID-19 Patients; a Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially due to limited data that have been released regarding the vaccine efficacy and safety in humans. Reviewing the recent research, Olive leaf was selected as a potential co-therapy supplement for the treatment and the improvement of clinical manifestations in COVID-19 patients. Olive leaves reported to be rich in phenolic compounds such as oleuropein, hydroxy tyrosol, verbascoside, apigenin-7-glucoside and luteolin-7-glucoside which has been reported as anti-SARS-CoV-2 metabolites in recent In silico, computational and in vitro studies. In addition, olive leaf extract was previously reported in several in vivo studies for its anti-inflammatory, analgesic, antipyretic, immunomodulatory and anti-thrombotic activities which is of a great benefit in the control of associated inflammatory cytokine storm and disseminated intravascular coagulation in COVID-19 patients. A placebo-controlled, randomized clinical trial at Fayoum University Hospital in Egypt will be conducted. RT-PCR confirmed COVID-19 adults showing mild to moderate disease will be enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive standardized olive leaves capsules (containing 20-50% oleuropein) or placebo up-to 10 days along with standard care. The expected outcomes included symptom alleviation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) and a 10-day mortality in intention-to-treat population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started May 2021
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 8, 2023
February 1, 2023
10 months
May 4, 2021
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Improving the clinical symptoms in mild to moderate COVID -19 patients
It is expected that the examined drug will alleviate symptoms such as fever, cough, sore throat and muscles ache
10 days after treatment
Viral clearance in mild to moderate COVID -19 patients
It is expected that the examined drug will make the Polymerase chain reaction (PCR ) results for the test group negative within 10 days of treatment
10 days after treatment
Improvement of analysis (CBC)
It is expected that the treatment will improve the lab analysis for treatment group such as increase lymphocyte count in complete blood count (CBC).
10 days after treatment
Improvement of analysis (CRP)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of C-reactive protein (CRP).
10 days after treatment
Improvement of analysis (LDH)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Lactate dehydrogenase (LDH).
10 days after treatment
Improvement of analysis (ESR)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Erythrocyte sedimentation rate (ESR).
10 days after treatment
Improvement of analysis (Ferritin)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of Ferritin.
10 days after treatment
Improvement of analysis (D-dimer)
It is expected that the treatment will improve the lab analysis for treatment group and prevent elevation and/or decrease the elevated values of D-dimer.
10 days after treatment
Secondary Outcomes (4)
Evaluate mortality rate in patients with confirmed COVID-19 moderately ill
10 days after treatment
Improvement of analysis (creatinine)
10 days after treatment
Improvement of analysis (ALT)
10 days after treatment
improvement of analysis (AST)
10 days after treatment
Study Arms (2)
Olive leaf capsules
ACTIVE COMPARATORNon-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a 50% standardized olive leaf capsule 750 mg (700 mg oleuropein/day; the active principle in olive leaf) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the active comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics.
Starch capsules
PLACEBO COMPARATORNon-hospitalized COVID-19 patients who have positive PCR results and show mild to moderate clinical manifestations and symptoms (20-30 patients) will receive a placebo starch capsules (750 mg) two times daily for a period of ten days alongside with the Egyptian protocol medications. All the placebo comparator participants should be adults, with no chronic diseases (except hypertension and diabetes), non addict or alcoholics.
Interventions
two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group
Eligibility Criteria
You may qualify if:
- Adults.
- Confirmed SARS-CoV-2 diagnosis (positive polymerase chain reaction by nasopharyngeal swab).
- Mild to Moderate COVID-19 patients.
- No history of the current use of olive leaf capsules supplement.
You may not qualify if:
- Severe and critical COVID-19 patients who need hospitalization.
- Patients need ventilatory support or showing chronic obstructive pulmonary disease (COPD).
- Patients showing any chronic disease (except hypertension and diabetes mellitus).
- Patients who have multiorgan failure.
- \. Use of alcohol, other investigational medicines, and illegal drugs (during the last 30 days).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shimaa Abdelgawad
Al Fayyum, 63514, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assisting lecturer, Pharmacognosy Department, Faculty of Pharmacy, Fayoum University, Egypt
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 5, 2021
Study Start
May 10, 2021
Primary Completion
March 1, 2022
Study Completion
August 1, 2022
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share