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Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients (GA&COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381871
Recruitment Status : Not yet recruiting
First Posted : May 11, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
University of Khartoum
Information provided by (Responsible Party):
Lamis Kaddam, Al-Neelain University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
COVID 19 Dietary Supplement: Acacia Senegal Dietary Supplement: Pectin Phase 2 Phase 3

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Acacia Pectin

Arm Intervention/treatment
Experimental: Intervention Group
This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose
Dietary Supplement: Acacia Senegal
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
Other Name: Gum Arabic

Placebo Comparator: Control group
This group will be provided with pectin powder provided as one-gram-dose
Dietary Supplement: Pectin
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks




Primary Outcome Measures :
  1. Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks ) [ Time Frame: 4 weeks ]
    Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values

  2. Mortality rate [ Time Frame: 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 ]
    The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo


Secondary Outcome Measures :
  1. Determine viral load in each patient [ Time Frame: 4 weeks ]
    Change of viral load from Baseline


Other Outcome Measures:
  1. clinical improvement and hospital discharge [ Time Frame: from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months ]
    Time of discharge from hospital after full recovery



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)

Exclusion Criteria:

  • Intubated patients on parental treatment

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): NCT04381871


Contacts
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Contact: Dr Babiker, PhD +249912951517 rashat33@yahoo.com
Contact: Shahenaz Satti, MSc +249912204825 shahenazsatti@gmail.com

Locations
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Sudan
Omdurman Teaching Hospital
Khartoum, Omdurman, Sudan
Jabra Hospital,
Khartoum, Sudan
Sponsors and Collaborators
Al-Neelain University
University of Khartoum
Investigators
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Study Chair: Mustafa KM Nimeiri, MD Al Neelain University, Faculty of Medicine
Study Director: Moawia M Mukhtar, PhD University of Khartom , Institute of Endemic Diseases
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lamis Kaddam, Dr.Lamis Kaddam, Al-Neelain University
ClinicalTrials.gov Identifier: NCT04381871    
Other Study ID Numbers: GA& COVID19
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lamis Kaddam, Al-Neelain University:
Gum Arabic
Immunomodulator