Hesperidin and Diosmin for Treatment of COVID-19

NCT04452799 | Unknown Early Phase 1

• 1 other identifier: 1111
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

SARS-CoV-2 or COVID-19 is representing the major global burden that implicated more than 10 million infected cases and 500 thousand deaths worldwide. The prevalence of this pandemic disease is expected to rise every day. The challenge is to control its rapid spread meanwhile looking for a specific treatment to improve patient outcomes. Hesperidin is a classical herbal medicine used worldwide for a long time with an excellent safety profile. Hesperidin is a well-known herbal medication used as an antioxidant and anti-inflammatory agent. Available shreds of evidence support the promising use of hesperidin in prophylaxis and treatment of COVID 19. Herein, we discuss the possible prophylactic and treatment mechanisms of hesperidin based on previous and recent findings. Hesperidin can block coronavirus from entering host cells through ACE2 receptors which can prevent the infection. Anti-viral activity of hesperidin might constitute a treatment option for COVID-19 through improving host cellular immunity against infection and its good anti-inflammatory activity may help in controlling cytokine storm. Hesperidin mixture with diosmin co-administrated with heparin protect against venous thromboembolism which may prevent disease progression. Based on that, hesperidin might be used as a meaningful prophylactic agent and a promising adjuvant treatment option against SARS-CoV-2 infection.

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

• PCR test

  PCR negative

  14 days

Secondary Outcomes (5)

• respiratory rate

  14 days

• patients PaO2

  14 days

• serum IL1β

  14 days

• serum TNF-α

  14 days

• Mortality rate

  14 days

Study Arms (2)

expermintal

EXPERIMENTAL

1000mg of (Hesperidin and Diosmin mixture) three times daily for 7 days 1000mg of (Hesperidin and Diosmin mixture) two times daily for 3 days

Drug: Hesperidin and Diosmin mixture

standard

ACTIVE COMPARATOR

standard care therapy in quarantine hospitals

Drug: Hesperidin and Diosmin mixture

Interventions

Hesperidin and Diosmin mixture DRUG

Interventional Clinical Trial

expermintal; standard

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed cases of Covid-19 (all by RT-PCR) Newly diagnosed asymptomatic or with upper respiratory tract infection (URTI) patients who will present with rhinitis, pharyngitis, or isolated low-grade fever and myalgia, Adult (18-65 Years old) Both sexes

You may not qualify if:

• Patients with bleeding disorders Patients with low to very low blood pressure Patients after surgery Immunocompromised patients taking medication upon screening

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• Haggag YA, El-Ashmawy NE, Okasha KM. Is hesperidin essential for prophylaxis and treatment of COVID-19 Infection? Med Hypotheses. 2020 Nov;144:109957. doi: 10.1016/j.mehy.2020.109957. Epub 2020 Jun 6.

  PMID: 32531538 RESULT

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Hesperidin

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomized double-blind controlled Parallel study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double-blind controlled Parallel study

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: July 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 30, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share