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Standardized Olive Leaf Capsules; as a Co-therapy in the Treatment of COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04873349
Recruitment Status : Not yet recruiting
First Posted : May 5, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Shimaa M. Abdelgawad, Fayoum University

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 30-day mortality in intention-to-treat population.


Condition or disease Intervention/treatment Phase
Covid19 COVID-19 Respiratory Infection Symptoms and Signs COVID-19 Acute Bronchitis Disseminated Intravascular Coagulation Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 10, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : September 30, 2021


Arm Intervention/treatment
Active Comparator: Olive leaf capsules
Non-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.
Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)
two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group

Placebo Comparator: Starch capsules
Non-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.
Dietary Supplement: Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)
two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group




Primary Outcome Measures :
  1. Improving the clinical symptoms in mild to moderate COVID -19 patients [ Time Frame: 5 days after treatment ]
    It is expected that the examined drug will alleviate symptoms such as fever, cough, sore throat and muscles ache

  2. Viral clearance in mild to moderate COVID -19 patients [ Time Frame: 10 days after treatment ]
    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

  3. improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) [ Time Frame: 5-10 days after treatment ]
    It is expected that the treatment will improve the lab analysis for treatment group such as increase lymphocyte count in complete blood count (CBC), prevent elevation and/or decrease the following elevated values of: D-dimer, C-Reactive protein (CRP), Lactate dehydrogenase (LDH), Erythrocyte sedimentation rate (ESR), creatinine, Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST).


Secondary Outcome Measures :
  1. evaluate 30-day mortality rate in patients with confirmed COVID-19 moderately ill [ Time Frame: 30 days after treatment ]
    It is expected that the drug will reduce the conversion in cases from moderate to sever cases and so decrease the mortality rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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Responsible Party: Shimaa M. Abdelgawad, Assisting lecturer, Pharmacognosy Department, Faculty of Pharmacy, Fayoum University, Egypt, Fayoum University
ClinicalTrials.gov Identifier: NCT04873349    
Other Study ID Numbers: EC 2121
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shimaa M. Abdelgawad, Fayoum University:
COVID-19, Infection, Bronchitis, Coagulation, Symptoms
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Bronchitis
Disseminated Intravascular Coagulation
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Oleuropein
Anti-Infective Agents
Antihypertensive Agents
Vasodilator Agents