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

NCT04468139 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 20-95M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid-19

Outcome Measures

Primary Outcomes (2)

• days of stay at hospital after treatment and discharge

  speed the days of recovery and discharge from hospital

  28 days

• serum zinc before and after treatment

  the level of serum zinc is very important especially at chronic diseases

  5-10 days

Secondary Outcomes (2)

• questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment ,

  28 days

• day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19

  28 days

Study Arms (1)

Quercetin

EXPERIMENTAL

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

Drug: Quercetin; Dietary Supplement: bromelain; Drug: Zinc; Drug: Vitamin C

Interventions

Quercetin DRUG

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

Quercetin

bromelain DIETARY_SUPPLEMENT

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

Quercetin

Zinc DRUG

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

Quercetin

Vitamin C DRUG

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

Quercetin

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• positive confirmed PCR covid-19
• moderate to severe cases
• obtained consent
• must be able to swallow tablets

You may not qualify if:

• Patients who live outside Saudia Arabia
• Pregnant women: Current known pregnancy positive pregnancy test.
• Lactating women.
• Documented allergy to pineapple or to quercetin
• Documented history of mental illnesses

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

Ministry of health.First health cluster ,Riaydh

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Quercetin; Bromelains; Zinc; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Hiba Hamadelnil elsaeed

  Netherlands: Ministry of Health, Welfare and Sports

  STUDY DIRECTOR

Central Study Contacts

amr ahmed

CONTACT

00966597310032; drmedahmed@gmail.com

abdullah Alqattan

CONTACT

00966540745588; abdullahalkattan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of mobile team tuberculosis ghubera, tuberculosis control program

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 13, 2020
• Study Start: June 20, 2020
• Primary Completion: July 20, 2020
• Study Completion: July 30, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

SA (1)