The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
Primary Purpose
Covid-19
Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Quercetin
bromelain
Zinc
Vitamin C
Sponsored by

About this trial
This is an interventional treatment trial for Covid-19
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- positive confirmed PCR covid-19
- moderate to severe cases
- obtained consent
- must be able to swallow tablets
Exclusion Criteria:
- 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
Sites / Locations
- Ministry of health.First health cluster ,RiaydhRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quercetin
Arm 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
Outcomes
Primary Outcome Measures
days of stay at hospital after treatment and discharge
speed the days of recovery and discharge from hospital
serum zinc before and after treatment
the level of serum zinc is very important especially at chronic diseases
Secondary Outcome Measures
questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment ,
according to questionnaire including BMI, smoking , underlying diseases like hypertension, diabetes , asthmatic , ..etc
day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19
day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19
Full Information
NCT ID
NCT04468139
First Posted
July 5, 2020
Last Updated
July 9, 2020
Sponsor
Ministry of Health, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT04468139
Brief Title
The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
Official Title
The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
July 20, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quercetin
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Quercetin
Intervention Description
Dietary Supplement: Quercetin Treatment a daily dose of quercetin (500 mg) will be taken orally by proven COVID-19 cases intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
bromelain
Intervention Description
Dietary Supplement:Bromealin Treatment a daily dose of bromelain(500 mg) will be taken orally by proven COVID-19 cases intervention
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
zinc 50 mg orally daily dose will be taken orally by proven COVID-19 cases intervention
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
vitamin c 1000 mg orally daily by proven COVID-19 cases intervention
Primary Outcome Measure Information:
Title
days of stay at hospital after treatment and discharge
Description
speed the days of recovery and discharge from hospital
Time Frame
28 days
Title
serum zinc before and after treatment
Description
the level of serum zinc is very important especially at chronic diseases
Time Frame
5-10 days
Secondary Outcome Measure Information:
Title
questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment ,
Description
according to questionnaire including BMI, smoking , underlying diseases like hypertension, diabetes , asthmatic , ..etc
Time Frame
28 days
Title
day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19
Description
day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
positive confirmed PCR covid-19
moderate to severe cases
obtained consent
must be able to swallow tablets
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr ahmed
Phone
00966597310032
Email
drmedahmed@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
abdullah Alqattan
Phone
00966540745588
Email
abdullahalkattan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiba Hamadelnil elsaeed
Organizational Affiliation
Netherlands: Ministry of Health, Welfare and Sports
Official's Role
Study Director
Facility Information:
Facility Name
Ministry of health.First health cluster ,Riaydh
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yousef albalawi
Phone
00966542460550
Email
dryousef37@gmail.com
12. IPD Sharing Statement
Learn more about this trial
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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