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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nigella | Experimental | The patient will receive a study treatment containing 100 capsules:
|
|
| Placebo Group | Placebo Comparator | The patient will also receive a study treatment containing 100 capsules:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella | Drug | The patient will receive a study treatment containing 100 capsules:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one months |
| Measure | Description | Time Frame |
|---|---|---|
| Death Rate | The occurrence of death within 30 days of randomization | one month |
| Rate of Requiring oxygen supplementation | Number of participants requiring oxygen supplementation |
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Inclusion Criteria: patients included in the two studies NIGCOV1 and NIGCOV2 must be:
Exclusion Criteria:
Given the non-homogeneity of the patients, the study population will be divided into two groups:
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| Name | Affiliation | Role |
|---|---|---|
| Riadh Boukef, professor | CHU Sahloul, Sousse, Tunisia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HU Sahloul, sousse, Tunisia | Sousse | Itinéraire Ceinture Cité Sahloul | 4054 | Tunisia | ||
| Riadh Boukef |
in the article publication
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
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RCT
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| Placebo | Drug | The patient will receive a study treatment containing 100 capsules:
|
|
| one month |
| Rate of Hospiatalization | Number of participants requiring hospitalization due to COVID19 infection | one month |
| Sahloul |
| Sousse Governorate |
| Tunisia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |