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Nigella 5 in the Treatment of SARS COV2 (COVID-19) (Nigelle5)

Primary Purpose

SARS-CoV2 Infection

Status
Completed
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
Nigella
Placebo
Sponsored by
Hôpital Universitaire Sahloul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV2 Infection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria:

  • 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

Sites / Locations

  • HU Sahloul, sousse, Tunisia
  • Riadh Boukef

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nigella

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Death Rate
The occurrence of death within 30 days of randomization
Rate of Requiring oxygen supplementation
Number of participants requiring oxygen supplementation
Rate of Hospiatalization
Number of participants requiring hospitalization due to COVID19 infection

Full Information

First Posted
May 28, 2021
Last Updated
February 18, 2022
Sponsor
Hôpital Universitaire Sahloul
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1. Study Identification

Unique Protocol Identification Number
NCT04914767
Brief Title
Nigella 5 in the Treatment of SARS COV2 (COVID-19)
Acronym
Nigelle5
Official Title
The Effectiveness of Nigella Sativa in the Treatment of SARS COV2 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nigella
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nigella
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Death or readmission or requiring oxygen supplementation
Description
The composite of death or need for hospitalization or requiring oxygen supplementation due to COVID-19 infection within the first 30 days of randomization
Time Frame
one months
Secondary Outcome Measure Information:
Title
Death Rate
Description
The occurrence of death within 30 days of randomization
Time Frame
one month
Title
Rate of Requiring oxygen supplementation
Description
Number of participants requiring oxygen supplementation
Time Frame
one month
Title
Rate of Hospiatalization
Description
Number of participants requiring hospitalization due to COVID19 infection
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riadh Boukef, professor
Organizational Affiliation
CHU Sahloul, Sousse, Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
HU Sahloul, sousse, Tunisia
City
Sousse
State/Province
Itinéraire Ceinture Cité Sahloul
ZIP/Postal Code
4054
Country
Tunisia
Facility Name
Riadh Boukef
City
Sahloul
State/Province
Sousse
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
in the article publication

Learn more about this trial

Nigella 5 in the Treatment of SARS COV2 (COVID-19)

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