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

Phase 2

• Conditions: COVID 19

• Registration Number: NCT04381871
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-12
• Study Start: 2020-06-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

• Intubated patients on parental treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )	4 weeks	Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values
Mortality rate	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

Name	Time	Method
Determine viral load in each patient	4 weeks	Change of viral load from Baseline

Trial Locations

Locations (2)

Omdurman Teaching Hospital; 🇸🇩 Khartoum, Omdurman, Sudan

Jabra Hospital,; 🇸🇩 Khartoum, Sudan