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

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

Sponsors

Lead Sponsor: Ministry of Health, Saudi Arabia

Source 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

Overall Status Recruiting
Start Date 2020-06-20
Completion Date 2020-07-30
Primary Completion Date 2020-07-20
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
days of stay at hospital after treatment and discharge 28 days
serum zinc before and after treatment 5-10 days
Secondary Outcome
Measure Time Frame
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
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Quercetin

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

Arm Group Label: Quercetin

Intervention Type: Dietary Supplement

Intervention Name: bromelain

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

Arm Group Label: Quercetin

Intervention Type: Drug

Intervention Name: Zinc

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

Arm Group Label: Quercetin

Intervention Type: Drug

Intervention Name: Vitamin C

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

Arm Group Label: Quercetin

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hiba Hamadelnil elsaeed Study Director Netherlands: Ministry of Health, Welfare and Sports
Overall Contact

Last Name: amr ahmed

Phone: 00966597310032

Email: [email protected]

Location
Facility: Status: Contact: Ministry of health.First health cluster ,Riaydh yousef albalawi 00966542460550 [email protected]
Location Countries

Saudi Arabia

Verification Date

2020-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ministry of Health, Saudi Arabia

Investigator Full Name: Amr kamel khalil Ahmed

Investigator Title: director of mobile team tuberculosis ghubera, tuberculosis control program

Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Quercetin

Type: Experimental

Description: 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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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