The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19

NCT ID: NCT04468139

Last Updated: 2020-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-20

Study Completion Date

2020-07-30

Brief Summary

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There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. The drugs we are chosen are used as clinical trials for antiviral and there is no proven guide for specificity and effectiveness against the virus so the results are different Now the clinical trials and research authorities are work speedily to target the most proven treatment for the virus so anything is infantile until now. the covid-19 with time be more explained by scientists it is steroid response disease and cause thromosis and cytokine storm , the aim of the study to inhibit viral replication and decrease the severity of the disease as antiviral and anticytokine storm , antithrombosis Zinc is a mineral element needed to regulate adaptive immune cells' functions. Higher level of intracellular zinc showed to increase intracellular pH; which affect on RNA-dependent RNA polymerase and decrease replication mechanism of RNA viruses. Therefore, drugs that described as zinc ionophores could be used with zinc supplement to act as antiviral against many RNA viruses including SARS-CoV-2 Quercetin is natural compound act as zinc ionophore to cause zinc influx intracellular.

Quercetin is a safe natural anti-oxidant and anti-inflammatory polyphenolic compound that found in various natural sources include onion, red grapes, honey and citrus fruits. It was shown that quercetin has the ability to chelate zinc ions and act as zinc ionophore. Therefore, quercetin could have antiviral activity against many RNA viruses . Quercetin, a flavonoid found in fruits and vegetables, has unique biological properties that may improve mental/physical performance and reduce infection risk ; These properties form the basis for potential benefits to overall health and disease resistance, including anti-carcinogenic, anti-inflammatory, antiviral, antioxidant, and psychostimulant activities, as well as the ability to inhibit lipid peroxidation, platelet aggregation and capillary permeability, and to stimulate mitochondrial biogenesis .There are various studies that report the immunomodulatory effect of bromelain . Bromelain activates natural killer cells and augments the production of granulocyte-macrophage-colony stimulating factor, IL-2, IL-6 and decreases the activation of Thelper cells. Thus, bromelain decreases the majority of inflammatory mediators and has demonstrated a significant role as an anti-inflammatory agent in various conditions Vitamin C is known as an essential anti-oxidant.,and enzymatic co-factor for physiological reactions such as hormone production, collagen synthesis and immune potentiation . Naturally, an insufficiency of vitamin C leads to severe injuries to multiple organs, especially to the heart and brain, since they are both highly aerobic organs that produce more oxygen radicals. In fact, studies of in vivo effect on vitamin C are difficult since most animals, except human and some primate, are capable of synthesizing vitamin C endogenously

Detailed Description

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Conditions

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Covid-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quercetin

Quercetin 500 g of quercetin Quercetin will be administered orally once daily, in the morning before breakfast for 5-10 days or patient improves or discharged

Group Type EXPERIMENTAL

Quercetin

Intervention Type DRUG

Dietary Supplement: Quercetin Treatment a daily dose of quercetin (500 mg) will be taken orally by proven COVID-19 cases intervention

bromelain

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement:Bromealin Treatment a daily dose of bromelain(500 mg) will be taken orally by proven COVID-19 cases intervention

Zinc

Intervention Type DRUG

zinc 50 mg orally daily dose will be taken orally by proven COVID-19 cases intervention

Vitamin C

Intervention Type DRUG

vitamin c 1000 mg orally daily by proven COVID-19 cases intervention

Interventions

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Quercetin

Dietary Supplement: Quercetin Treatment a daily dose of quercetin (500 mg) will be taken orally by proven COVID-19 cases intervention

Intervention Type DRUG

bromelain

Dietary Supplement:Bromealin Treatment a daily dose of bromelain(500 mg) will be taken orally by proven COVID-19 cases intervention

Intervention Type DIETARY_SUPPLEMENT

Zinc

zinc 50 mg orally daily dose will be taken orally by proven COVID-19 cases intervention

Intervention Type DRUG

Vitamin C

vitamin c 1000 mg orally daily by proven COVID-19 cases intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. positive confirmed PCR covid-19
3. moderate to severe cases
4. obtained consent
5. must be able to swallow tablets

Exclusion Criteria

1. Patients who live outside Saudia Arabia
2. Pregnant women: Current known pregnancy positive pregnancy test.
3. Lactating women.
4. Documented allergy to pineapple or to quercetin
5. Documented history of mental illnesses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Amr kamel khalil Ahmed

director of mobile team tuberculosis ghubera, tuberculosis control program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiba Hamadelnil elsaeed

Role: STUDY_DIRECTOR

Netherlands: Ministry of Health, Welfare and Sports

Locations

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Ministry of health.First health cluster ,Riaydh

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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amr ahmed

Role: CONTACT

00966597310032

abdullah Alqattan

Role: CONTACT

00966540745588

Facility Contacts

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yousef albalawi

Role: primary

00966542460550

Other Identifiers

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20-95M

Identifier Type: -

Identifier Source: org_study_id

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