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

COVID 19 Clinical Trial

— GA&COVID19  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04381871
• Other study ID #: GA& COVID19
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: May 2020
• Source: Al-Neelain University
• Contact: Dr Babiker, PhD
• Phone: +249912951517
• Email: rashat33[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Intubated patients on parental treatment

Related Conditions & MeSH terms

• COVID 19

Intervention

Dietary Supplement:
• Acacia Senegal
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
• Pectin
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks

Locations

Country	Name	City	State
Sudan	Jabra Hospital,	Khartoum
Sudan	Omdurman Teaching Hospital	Khartoum	Omdurman

Sponsors (2)

Lead Sponsor	Collaborator
Al-Neelain University	University of Khartoum

Country where clinical trial is conducted

Sudan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Ruscitti P, Berardicurti O, Iagnocco A, Giacomelli R. Cytokine storm syndrome in severe COVID-19. Autoimmun Rev. 2020 May 3:102562. doi: 10.1016/j.autrev.2020.102562. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical improvement and hospital discharge	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
Primary	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
Primary	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	Determine viral load in each patient	Change of viral load from Baseline	4 weeks