Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients

Study Overview
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Brief Summary
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To study the efficacy of Gum Arabic as an immuno modulator and anti-inflammatory agent among COVID 19 seropositive patients..Half of participants will receive Gum Arabic and the other half will receive placebo

Detailed Description
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Randomized placebo controlled trial including COVID 19 seropositive patients will be treated with 30 gram per day for 4 weeks, compared to placebo group treated for the same duration in positive COVID 19 patients. Blood samples will be taken first at base line level, after two weeks and after the intervention after satisfying the inclusion and exclusion criteria. The main objective is to assess the effect of Gum Arabic (acacia Senegal) on immune system among COVID-19 patients. The outcome of this project understand SARS-CoV-2 immune response in COVID patients and the effect of Gum Arabic (Acacia Senegal) consumption to counteract progression of the disease

Official Title
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Phase II ,III Randomized Double Blind Parallel Arms Clinical Trial of Potential Role of Gum Arabic ( Acacia Senegal) as Immunomodulatory Agent Among COVID 19 Patients in Sudan

Conditions
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COVID 19

Intervention / Treatment
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* Dietary Supplement: Acacia Senegal
* Dietary Supplement: Pectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed) Exclusion Criteria: Intubated patients on parental treatment

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose | Dietary Supplement: Acacia Senegal<br>* Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks<br>* Other names: Gum Arabic;|
| Placebo Comparator: Control group<br>This group will be provided with pectin powder provided as one-gram-dose | Dietary Supplement: Pectin<br>* Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks ) | Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values | 4 weeks | 
| Mortality rate | The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo | from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine viral load in each patient | Change of viral load from Baseline | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gum Arabic, Immunomodulator