Clinical trial NCT04381871: Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID 19
Keywords: Gum Arabic
Immunomodulator
Lead sponsor: Al-Neelain University
Sponsor class: OTHER
Collaborators: name: University of Khartoum
First posted: 2020-05-11
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Intubated patients on parental treatment

Primary outcomes:
measure: Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )
timeFrame: 4 weeks
measure: Mortality rate
timeFrame: 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:
measure: Determine viral load in each patient
timeFrame: 4 weeks
Other outcomes:
measure: clinical improvement and hospital discharge
timeFrame: from the date of assignment until the date of hospital discharge for the last assigned case, whichever comes first, assessed up to two months
Locations:
city: Khartoum
country: Sudan
facility: Omdurman Teaching Hospital
state: Omdurman
city: Khartoum
country: Sudan
facility: Jabra Hospital,
Study officials:
affiliation: Al Neelain University, Faculty of Medicine
name: Mustafa KM Nimeiri, MD
role: STUDY_CHAIR
affiliation: University of Khartom , Institute of Endemic Diseases
name: Moawia M Mukhtar, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
citation: 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.
citation: 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.