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

NCT04381871 | Unknown Phase 2

• 1 other identifier: GA& COVID19
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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

Conditions

COVID 19

Keywords

Gum Arabic; Immunomodulator

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Determine viral load in each patient

  4 weeks

Other Outcomes (1)

• clinical improvement and hospital discharge

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose

Dietary Supplement: Acacia Senegal

Control group

PLACEBO COMPARATOR

This group will be provided with pectin powder provided as one-gram-dose

Dietary Supplement: Pectin

Interventions

Acacia Senegal DIETARY_SUPPLEMENT

Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks

Also known as: Gum Arabic

Intervention Group

Pectin DIETARY_SUPPLEMENT

Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks

Control group

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Intubated patients on parental treatment

Sponsors & Collaborators

• Al-Neelain University: lead
• University of Khartoum: collaborator

Study Sites (2)

Omdurman Teaching Hospital

Khartoum, Omdurman, Sudan

Location

Jabra Hospital,

Khartoum, Sudan

Location

Related Publications (5)

• Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.

  PMID: 32328307 BACKGROUND

• Kamal E, Kaddam LA, Dahawi M, Osman M, Salih MA, Alagib A, Saeed A. Gum Arabic Fibers Decreased Inflammatory Markers and Disease Severity Score among Rheumatoid Arthritis Patients, Phase II Trial. Int J Rheumatol. 2018 Jul 5;2018:4197537. doi: 10.1155/2018/4197537. eCollection 2018.

  PMID: 30112005 BACKGROUND

• Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, Li P, Hu B, Wang J, Hu C, Jin Y, Niu X, Ping R, Du Y, Li T, Xu G, Hu Q, Tu L. Clinical Characteristics of COVID-19 Patients With Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020 May;115(5):766-773. doi: 10.14309/ajg.0000000000000620.

  PMID: 32287140 BACKGROUND

• Ruscitti P, Berardicurti O, Iagnocco A, Giacomelli R. Cytokine storm syndrome in severe COVID-19. Autoimmun Rev. 2020 Jul;19(7):102562. doi: 10.1016/j.autrev.2020.102562. Epub 2020 May 3. No abstract available.

  PMID: 32376400 BACKGROUND

• Kaddam L, Babiker R, Ali S, Satti S, Ali N, Elamin M, Mukhtar M, Elnimeiri M, Saeed A. Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial. Trials. 2020 Sep 5;21(1):766. doi: 10.1186/s13063-020-04707-2.

  PMID: 32891160 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Gum Arabic; Pectins

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Plant Extracts; Plant Preparations

Study Officials

• Mustafa KM Nimeiri, MD

  Al Neelain University, Faculty of Medicine

  STUDY CHAIR

• Moawia M Mukhtar, PhD

  University of Khartom , Institute of Endemic Diseases

  STUDY DIRECTOR

Central Study Contacts

Dr Babiker, PhD

CONTACT

+249912951517; rashat33@yahoo.com

Shahenaz Satti, MSc

CONTACT

+249912204825; shahenazsatti@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Lamis Kaddam

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 11, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SU (2)