COVID-19 Acute Respiratory Distress SyndromeNigCOV3NCT04989101
Nigelle 5 in Prevention of Influanza
A study testing Nigella in people with COVID-19 Acute Respiratory Distress Syndrome, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial summary
This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Nigella
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 5 Jun 2021to 31 Aug 2021
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with an age> 40 years
Who cannot join
- Being positive for COVID or having contracted it previously
- Positive for COVID between D1 and D5 of the study, meaning that there was infection before inclusion.
- Immunocompromised (HIV, other ...)
- Under chemotherapy
- On immunosuppressants
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: Nigelle 5 Study Project/ Prevention of Influenza Syndroms
This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
Read the detailed description
This study will focus on the evaluation of the natural product Nigella Sativa in the fractalized form. "Lactose Nigelle 5" from the Tunisian company Fractal Tun, in terms of possible contribution to the prevention of influenza-like illnesses, in particular COVID-19
It will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
The monitoring and evaluation will last for 3 weeks with taking the product Nig5, followed by a week without taking the product. That is 4 weeks in all.
More than 30 physicians volunteered to participate in this study without remuneration and without consultation fees for the candidates.
This study will be supervised by Professor Riadh Boukef, head of emergency services at Sahloul University Hospital, who will collect all the data afterwards in order to submit them to the statistical tools in force.
Professor Boukef will be responsible for preparing the abstract and publishing it on his behalf in the scientific journals of his choice, naming the doctors who participated as well as the product in question and the company that markets it in Tunisia.
27 free practice doctors participate in patient recruitment: AMICHE Sondèss BAHA Mohamed BEN AMARA Mohamed Khalil BEN ARBIA Karima BEN AYAD Afef BEN AYED KTARI Fouzia BENTALEB Mourad BESBES Mohamed CHTOUROU Iteb DHOUIB Manel DJAIT Mohamed DJEMAL Najla ELFIDHA Mongi FOURATI Imen FRIH Sabria FRIKHA Fahmi GHARBI Nadia KAMMOUN Naziha KETATA Mourad MHIRI Ikram NJAH Jamil OUARGHI Sameh REGAIEG Mourad SAKKA Samar TRABELSI Hinda ZOUARI Imen ZOUARI Nassira
- Being tested
- Nigella
- Keywords
- Nigelle 5CH, Covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NigellaDrug
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Nigelle Group | Active comparator | The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month. Receives: Drug: Nigella |
| Placebo Group | No intervention | Follow-up should be done weekly for 1 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SarsCOV2 Infection
Respiratory infection
Measured: one month
Secondary outcomes (1)
Contamination
contamination of the entourage in the event of respiratory infection by COVID19
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start5 Jun 2021
- Primary completion31 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
- Investigators
- Riadh Boukef, professor, Principal investigator, CHU Sahloul, Sousse, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989101
- Sponsor's protocol ID
- NigCOV 3
- Acronym
- NigCOV3
- Status last verified
- Jan 2022
- First submitted
- 24 Jul 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nigelle 5 Study Project/ Prevention of Influenza Syndroms
- ClinicalTrials.gov ID
- NCT04989101
- Acronym / sponsor ID
- NigCOV3 / NigCOV 3
- Keywords
- Nigelle 5CH, Covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 4 Aug 2021 (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.
This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
Detailed description
This study will focus on the evaluation of the natural product Nigella Sativa in the fractalized form. "Lactose Nigelle 5" from the Tunisian company Fractal Tun, in terms of possible contribution to the prevention of influenza-like illnesses, in particular COVID-19
It will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
The monitoring and evaluation will last for 3 weeks with taking the product Nig5, followed by a week without taking the product. That is 4 weeks in all.
More than 30 physicians volunteered to participate in this study without remuneration and without consultation fees for the candidates.
This study will be supervised by Professor Riadh Boukef, head of emergency services at Sahloul University Hospital, who will collect all the data afterwards in order to submit them to the statistical tools in force.
Professor Boukef will be responsible for preparing the abstract and publishing it on his behalf in the scientific journals of his choice, naming the doctors who participated as well as the product in question and the company that markets it in Tunisia.
27 free practice doctors participate in patient recruitment: AMICHE Sondèss BAHA Mohamed BEN AMARA Mohamed Khalil BEN ARBIA Karima BEN AYAD Afef BEN AYED KTARI Fouzia BENTALEB Mourad BESBES Mohamed CHTOUROU Iteb DHOUIB Manel DJAIT Mohamed DJEMAL Najla ELFIDHA Mongi FOURATI Imen FRIH Sabria FRIKHA Fahmi GHARBI Nadia KAMMOUN Naziha KETATA Mourad MHIRI Ikram NJAH Jamil OUARGHI Sameh REGAIEG Mourad SAKKA Samar TRABELSI Hinda ZOUARI Imen ZOUARI Nassira
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nigelle Group | Active comparator | Drug: NigellaThe candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month. |
| Placebo Group | No intervention | –Follow-up should be done weekly for 1 month. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with an age> 40 years
Key exclusion criteria (6 listed)
- Being positive for COVID or having contracted it previously
- Positive for COVID between D1 and D5 of the study, meaning that there was infection before inclusion.
- Immunocompromised (HIV, other ...)
- Under chemotherapy
- On immunosuppressants
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 |
|---|---|---|
| NigellaThe candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month. | Drug | Nigelle Group |
Primary outcome
SarsCOV2 Infection
Time frame: one month
Respiratory infection
1 secondary outcome
Contamination
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Yes. Data Statistical analysis
Related trials for COVID-19 Acute Respiratory Distress Syndrome
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingPhase 1/2
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
Systemic Inflammatory Response Syndrome
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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella in people with COVID-19 Acute Respiratory Distress Syndrome, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
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 6 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: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SarsCOV2 Infection (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2022.