Status:
COMPLETED
Nigella 5 in the Treatment of SARS COV2 (COVID-19)
Lead Sponsor:
Hôpital Universitaire Sahloul
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief 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 epid...
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...
Eligibility Criteria
Inclusion
- patients included in the two studies NIGCOV1 and NIGCOV2 must be:
- Men and women at least 40 years old, able and willing to give informed consent;
- Ambulatory (NIGCOV1) or hospitalized (NIGCOV2) environment;
- Patient with dyspnea or with a positive gait test (NIGCOV2);
- The patient must have at least one of the following high risk criteria: 70 years or older, obesity (BMI ≥ 30 kg / m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥ 150 mm Hg), respiratory disease known (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary artery disease, fever ≥ 38.4 ° C within the last 48 hours, dyspnea at the time of presentation (only patients included on NIGCOV2), bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count (only patients included on NIGCOV2);
- The patient is not of childbearing age, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing age and uses at least one method of contraception and preferably two complementary forms of contraception comprising a method of barrier throughout the study and for 30 days after the end of the study;
- The patient must be able and willing to comply with the requirements of this study protocol.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04914767
Start Date
March 1 2021
End Date
December 31 2021
Last Update
February 21 2022
Active Locations (2)
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1
HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
2
Riadh Boukef
Sahloul, Sousse Governorate, Tunisia