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

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ClinicalTrials.gov Identifier: NCT04468139
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia

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


Condition or disease Intervention/treatment Phase
Covid-19 Drug: Quercetin Dietary Supplement: bromelain Drug: Zinc Drug: Vitamin C Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
Actual Study Start Date : June 20, 2020
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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

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

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

Drug: Vitamin C
vitamin c 1000 mg orally daily by proven COVID-19 cases intervention




Primary Outcome Measures :
  1. days of stay at hospital after treatment and discharge [ Time Frame: 28 days ]
    speed the days of recovery and discharge from hospital

  2. serum zinc before and after treatment [ Time Frame: 5-10 days ]
    the level of serum zinc is very important especially at chronic diseases


Secondary Outcome Measures :
  1. questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment , [ Time Frame: 28 days ]
    according to questionnaire including BMI, smoking , underlying diseases like hypertension, diabetes , asthmatic , ..etc

  2. day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19 [ Time Frame: 28 days ]
    day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468139


Contacts
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Contact: amr ahmed 00966597310032 drmedahmed@gmail.com
Contact: abdullah Alqattan 00966540745588 abdullahalkattan@gmail.com

Locations
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Saudi Arabia
Ministry of health.First health cluster ,Riaydh Recruiting
Riyadh, Saudi Arabia
Contact: yousef albalawi    00966542460550    dryousef37@gmail.com   
Sponsors and Collaborators
Ministry of Health, Saudi Arabia
Investigators
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Study Director: Hiba Hamadelnil elsaeed Netherlands: Ministry of Health, Welfare and Sports
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Responsible Party: Amr kamel khalil Ahmed, director of mobile team tuberculosis ghubera, tuberculosis control program, Ministry of Health, Saudi Arabia
ClinicalTrials.gov Identifier: NCT04468139    
Other Study ID Numbers: 20-95M
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ascorbic Acid
Quercetin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents