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

May 8, 2020 updated by: Lamis Kaddam, Al-Neelain University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sudan
      • Khartoum, Sudan
        • Jabra Hospital,
    • Omdurman
      • Khartoum, Omdurman, Sudan
        • Omdurman Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Intubated patients on parental treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

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 )
Time Frame: 4 weeks
Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values
4 weeks
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
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
Time Frame: 4 weeks
Change of viral load from Baseline
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Neelain University

Collaborators

University of Khartoum

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA& COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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