COVID 19Phase 2/3GA&COVID19NCT04381871
Potential Role of Gum Arabic as Immunomodulatory Agent Among COVID 19 Patients
A Phase 2/3 study testing Acacia Senegal and Pectin in people with COVID 19, run by Al-Neelain University at 2 sites in Sudan.
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 Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- COVID 19
- What is being tested?
- Acacia Senegal and Pectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesSudan
- Study dates
- 1 Jun 2020to 1 Sep 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)
Who cannot join
- Intubated patients on parental treatment
Trial locations and contacts
2 sites in 1 country.
Sudan2 sites
Omdurman Teaching Hospital
Khartoum, Omdurman
Jabra Hospital,
Khartoum
About this study
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
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
Read the 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
- Conditions
- COVID 19
- Being tested
- Acacia Senegal, Pectin
- Keywords
- Gum Arabic, Immunomodulator
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia SenegalDietary supplement
Also called Gum Arabic
Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
PectinDietary supplement
Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose Receives: Dietary Supplement: Acacia Senegal |
| Control group | Placebo comparator | This group will be provided with pectin powder provided as one-gram-dose Receives: Dietary Supplement: Pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Mortality rate
The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo
Measured: 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
Change of viral load from Baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Neelain University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Khartoum
- Responsible party
- Principal investigator, Lamis Kaddam, Al-Neelain University
- Investigators
- Mustafa KM Nimeiri, MD, Study chair, Al Neelain University, Faculty of MedicineMoawia M Mukhtar, PhD, Study director, University of Khartom , Institute of Endemic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381871
- Sponsor's protocol ID
- GA& COVID19
- Acronym
- GA&COVID19
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32328307Kamal 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.
PubMed 30112005Pan 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.
PubMed 32287140Ruscitti 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.
PubMed 32376400Kaddam 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.
PubMed 32891160
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04381871
- Acronym / sponsor ID
- GA&COVID19 / GA& COVID19
- Conditions
- COVID 19
- Keywords
- Gum Arabic, Immunomodulator
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Al-Neelain UniversityUniversity, hospital or other
- Collaborators
- University of Khartoum
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Acacia SenegalThis arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose |
| Control group | Placebo comparator | Dietary Supplement: PectinThis group will be provided with pectin powder provided as one-gram-dose |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COVID 19 infected as proved by real time PCR (polymerase chain reaction) .( newly diagnosed)
Key exclusion criteria (1 listed)
- Intubated patients on parental treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acacia SenegalAlso: Gum ArabicOral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks | Dietary supplement | Intervention Group |
| PectinOral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks | Dietary supplement | Control group |
Primary outcome
Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )
Time frame: 4 weeks
Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values
Mortality rate
Time frame: 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
1 secondary outcome
Determine viral load in each patient
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 32328307Ali 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.
- Background: PubMed 30112005Kamal 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.
- Background: PubMed 32287140Pan 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.
- Background: PubMed 32376400Ruscitti 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.
- Derived from this study: PubMed 32891160Kaddam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa KM Nimeiri, MD study chair
Al Neelain University, Faculty of Medicine
Moawia M Mukhtar, PhD study director
University of Khartom , Institute of Endemic Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acacia Senegal and Pectin in people with COVID 19, run by Al-Neelain University at 2 sites in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Babiker, PhD (+249912951517, rashat33@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks ) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381871, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.