Your browser doesn't support javascript.
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.
Kaddam, Lamis; Babiker, Rasha; Ali, Sara; Satti, Shahinaz; Ali, Nour; Elamin, Maha; Mukhtar, Mowaia; Elnimeiri, Mustafa; Saeed, Amal.
  • Kaddam L; Department of Physiology, Faculty of Medicine, Alneelain University Khartoum, P.O. Box: 11121, 12702, Khartoum, Sudan. lamiskaddam@hotmail.com.
  • Babiker R; Present Address: Department of Physiology, Faculty of Medicine, King Abdul-Aziz University, Rabigh, Saudi Arabia. lamiskaddam@hotmail.com.
  • Ali S; Department of Physiology, Faculty of Medicine, National University-Sudan, Khartoum, Sudan.
  • Satti S; Department of Microbiology, Faculty of Medical Laboratory Sciences, International University of Africa, Khartoum, Sudan.
  • Ali N; Department of Physiology, Faculty of Medicine, Alneelain University Khartoum, P.O. Box: 11121, 12702, Khartoum, Sudan.
  • Elamin M; Department of Physiology, Faculty of Medicine, Nile University, Khartoum, Sudan.
  • Mukhtar M; Department of Biochemistry, Faculty of Medicine, Alneelain University, Khartoum, Sudan.
  • Elnimeiri M; Institute of Endemic Diseases, Faculty of Medicine, University of Khartoum, Khartoum, Sudan.
  • Saeed A; Department of Community Medicine, Faculty of Medicine, Alneelain University, Khartoum, Sudan.
Trials ; 21(1): 766, 2020 Sep 05.
Article in English | MEDLINE | ID: covidwho-745676
Semantic information from SemMedBD (by NLM)
1. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
2. Dietary Modification USES Anti-Inflammatory Agents
Subject
Dietary Modification
Predicate
USES
Object
Anti-Inflammatory Agents
3. Immunoregulation PROCESS_OF Patients
Subject
Immunoregulation
Predicate
PROCESS_OF
Object
Patients
4. TNF protei INTERACTS_WITH C0018389
Subject
TNF protei
Predicate
INTERACTS_WITH
Object
C0018389
5. Intubated PROCESS_OF Patients
Subject
Intubated
Predicate
PROCESS_OF
Object
Patients
6. Gum Arabic ADMINISTERED_TO Intervention Group
Subject
Gum Arabic
Predicate
ADMINISTERED_TO
Object
Intervention Group
7. Cessation of life PROCESS_OF Patients
Subject
Cessation of life
Predicate
PROCESS_OF
Object
Patients
8. Gum Arabic ADMINISTERED_TO Patients
Subject
Gum Arabic
Predicate
ADMINISTERED_TO
Object
Patients
9. Gum Arabic compared_with Placebos
Subject
Gum Arabic
Predicate
compared_with
Object
Placebos
10. Placebos ADMINISTERED_TO Patients
Subject
Placebos
Predicate
ADMINISTERED_TO
Object
Patients
11. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
12. Dietary Modification USES Anti-Inflammatory Agents
Subject
Dietary Modification
Predicate
USES
Object
Anti-Inflammatory Agents
13. Immunoregulation PROCESS_OF Patients
Subject
Immunoregulation
Predicate
PROCESS_OF
Object
Patients
14. TNF protein, human|TNF INTERACTS_WITH Gum Arabic
Subject
TNF protein, human|TNF
Predicate
INTERACTS_WITH
Object
Gum Arabic
15. Intubated PROCESS_OF Patients
Subject
Intubated
Predicate
PROCESS_OF
Object
Patients
16. Gum Arabic ADMINISTERED_TO Intervention Group
Subject
Gum Arabic
Predicate
ADMINISTERED_TO
Object
Intervention Group
17. Cessation of life PROCESS_OF Patients
Subject
Cessation of life
Predicate
PROCESS_OF
Object
Patients
18. Gum Arabic ADMINISTERED_TO Patients
Subject
Gum Arabic
Predicate
ADMINISTERED_TO
Object
Patients
19. Gum Arabic compared_with Placebos
Subject
Gum Arabic
Predicate
compared_with
Object
Placebos
20. Placebos ADMINISTERED_TO Patients
Subject
Placebos
Predicate
ADMINISTERED_TO
Object
Patients
ABSTRACT

OBJECTIVES:

To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. To study the effect of GA on the level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load. Secondary outcomes will be the effect of GA oral intake on mortality rate and days of hospital admission. TRIAL

DESIGN:

Quadruple blind, randomized placebo-controlled clinical trial Phase II & III. Prospective, two-arm, parallel-group, randomised (11 allocation ratio) superiority trial of oral GA among seropositive COVID-19 patients.

PARTICIPANTS:

Inclusion criteria COVID-19 infected (newly diagnosed) as proved by real-time PCR within 72 hours of PCR. Age 8-90 years Both genders Exclusion criteria Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan. INTERVENTION AND COMPARATOR Experimental Intervention Group This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose once daily for four weeks Placebo Comparator Control group This group will be provided with pectin powder provided as one-gram-dose once daily for four weeks Both GA and placebo will be in addition to standard care treatment based on local clinical guidelines. MAIN

OUTCOMES:

Mean change from baseline score of Immune Response to end of the trial. Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization). Mortality rate The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]). RANDOMISATION Randomization (11 allocation ratio) and will be conducted using a sequence of computer-generated random numbers by an independent individual. Each participating centre will be assigned a special code generated by the computer. The randomization will be kept by the PI and a research assistant. BLINDING (MASKING) Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups. TRIAL STATUS Protocol Version no 2, 30th June 2020. Recruitment will start on 15th September 2020. The intended completion date is 15th January 2021. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04381871 . Date of trial registration 11 May 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Gum Arabic / Immunologic Factors Subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Gum Arabic / Immunologic Factors Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Prognostic study Language: English Journal: Trials Clinical aspect: Therapy Year: 2020

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Gum Arabic / Immunologic Factors Subject: Pneumonia, Viral / Coronavirus Infections / Betacoronavirus / Gum Arabic / Immunologic Factors Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Observational study / Prognostic study Language: English Journal: Trials Clinical aspect: Therapy Year: 2020
...