SARS-CoV2 InfectionPhase 1Nigelle5NCT04914767
Nigella 5 in the Treatment of SARS COV2 (COVID-19)
A Phase 1 study testing Nigella in people with SARS-CoV2 Infection, run by Hôpital Universitaire Sahloul at 2 sites in Tunisia.
Trial summary
The world is currently facing a crisis because of this potentially fatal situation of the COVID-19 epidemic without proven efficacy for any drug treatment, while the vaccination is not yet. This epidemic is caused by a new betacorona virus, now called SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Nigella
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient currently in shock or exhibiting hemodynamic instability;
- Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
- Pregnant or breastfeeding patient
- Patient with a history of allergic reaction or significant sensitivity to Nigella;
- The patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.
- Given the non-homogeneity of the patients, the study population will be divided into two groups:
- group of outpatients: Ambulatory patients = NIGCOV1 study
- and inpatient group: Hospitalised patients = NIGCOV2 study Statistical analysis will be carried out for each group separately
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Riadh Boukef
Sahloul, Sousse Governorate
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, 4054
About this study
Official title: The Effectiveness of Nigella Sativa in the Treatment of SARS COV2 (COVID-19)
The world is currently facing a crisis because of this potentially fatal situation of the COVID-19 epidemic without proven efficacy for any drug treatment, while the vaccination is not yet.
This epidemic is caused by a new betacorona virus, now called SARS-CoV-2. The most common symptoms reported are fever, cough or chest tightness, and dyspnea. Most cases have a mild course
Read the detailed description
In the absence of proven antiviral therapy or specific vaccination against COVID-19, Nigella seed oil is suggested as a potential supplement due to its known immunostimulatory and antiviral activities in previous published studies.
Nigella (known as black seed) in the Latin language or "Habatulbarakah" in the Arabic language, is a food supplement and a medicinal plant well known in Arab and Islamic culture. It is used as a food spice and it has a lot of medical claims that come from different historical backgrounds. Nigella seeds contain several active compounds that have been isolated, identified and reported, the most important being thymoquinone.
In the literature, black seed has shown several pharmacological activities, including anti-inflammatory, antiviral and immunostimulatory activities.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Nigella, Placebo
- 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 patient will receive a study treatment containing 100 capsules:
- One capsule every two hours for the first three days.
- From the fourth day, the patient will take one capsule, three times a day for 12 days.
PlaceboDrug
The patient will receive a study treatment containing 100 capsules:
- One capsule every two hours for the first three days.
- From the fourth day, the patient will take one capsule, three times a day for 12 days.
| Study group | Role | What they receive |
|---|---|---|
| Nigella | Experimental | The patient will receive a study treatment containing 100 capsules:
* One capsule every two hours for the first three days.
* From the fourth day, the patient will take one capsule, three times a day for 12 days. Receives: Drug: Nigella |
| Placebo Group | Placebo comparator | The patient will also receive a study treatment containing 100 capsules:
* One capsule every two hours for the first three days.
* From the fourth day, the patient will take one capsule, three times a day for 12 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Death or readmission or requiring oxygen supplementation
The composite of death or need for hospitalization or requiring oxygen supplementation due to COVID-19 infection within the first 30 days of randomization
Measured: one months
Secondary outcomes (3)
Death Rate
The occurrence of death within 30 days of randomization
Measured: one month
Rate of Requiring oxygen supplementation
Number of participants requiring oxygen supplementation
Measured: one month
Rate of Hospiatalization
Number of participants requiring hospitalization due to COVID19 infection
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 posted7 Jun 2021
- Study start1 Mar 2021
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT04914767
- Sponsor's protocol ID
- NigCOV1&2
- Acronym
- Nigelle5
- Status last verified
- Feb 2022
- First submitted
- 28 May 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: in the article publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nigella Sativa in the Treatment of SARS COV2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04914767
- Acronym / sponsor ID
- Nigelle5 / NigCOV1&2
- Conditions
- SARS-CoV2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jun 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.
The world is currently facing a crisis because of this potentially fatal situation of the COVID-19 epidemic without proven efficacy for any drug treatment, while the vaccination is not yet.
This epidemic is caused by a new betacorona virus, now called SARS-CoV-2. The most common symptoms reported are fever, cough or chest tightness, and dyspnea. Most cases have a mild course
Detailed description
In the absence of proven antiviral therapy or specific vaccination against COVID-19, Nigella seed oil is suggested as a potential supplement due to its known immunostimulatory and antiviral activities in previous published studies.
Nigella (known as black seed) in the Latin language or "Habatulbarakah" in the Arabic language, is a food supplement and a medicinal plant well known in Arab and Islamic culture. It is used as a food spice and it has a lot of medical claims that come from different historical backgrounds. Nigella seeds contain several active compounds that have been isolated, identified and reported, the most important being thymoquinone.
In the literature, black seed has shown several pharmacological activities, including anti-inflammatory, antiviral and immunostimulatory activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Nigella | Experimental | Drug: NigellaThe patient will receive a study treatment containing 100 capsules: * One capsule every two hours for the first three days. * From the fourth day, the patient will take one capsule, three times a day for 12 days. |
| Placebo Group | Placebo comparator | Drug: PlaceboThe patient will also receive a study treatment containing 100 capsules: * One capsule every two hours for the first three days. * From the fourth day, the patient will take one capsule, three times a day for 12 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Patient currently in shock or exhibiting hemodynamic instability;
- Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
- Pregnant or breastfeeding patient
- Patient with a history of allergic reaction or significant sensitivity to Nigella;
- The patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.
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 patient will receive a study treatment containing 100 capsules: * One capsule every two hours for the first three days. * From the fourth day, the patient will take one capsule, three times a day for 12 days. | Drug | Nigella |
| PlaceboThe patient will receive a study treatment containing 100 capsules: * One capsule every two hours for the first three days. * From the fourth day, the patient will take one capsule, three times a day for 12 days. | Drug | Placebo Group |
Primary outcome
Rate of Death or readmission or requiring oxygen supplementation
Time frame: one months
The composite of death or need for hospitalization or requiring oxygen supplementation due to COVID-19 infection within the first 30 days of randomization
3 secondary outcomes
Death Rate
Time frame: one month
Rate of Requiring oxygen supplementation
Time frame: one month
Rate of Hospiatalization
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 21 Feb 2022.
- Individual participant dataSharing planned: No. in the article publication
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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.
Riadh Boukef, professor principal investigator
CHU Sahloul, Sousse, Tunisia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nigella in people with SARS-CoV2 Infection, run by Hôpital Universitaire Sahloul at 2 sites 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 0 inclusion and 8 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 21 Feb 2022. 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 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. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of Death or readmission or requiring oxygen supplementation (time frame: one months). 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 21 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.