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

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Drug: Nigella; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 1

Contacts and Locations

Study Locations

• Tunisia
  • Itinéraire Ceinture Cité Sahloul
    • Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
      • HU Sahloul, sousse, Tunisia
  • Sousse
    • Sahloul, Sousse, Tunisia
      • Riadh Boukef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nigella; 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.	Drug: Nigella; 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.
PLACEBO_COMPARATOR: Placebo Group; 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.	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	one month
Rate of Hospiatalization	Number of participants requiring hospitalization due to COVID19 infection	one month

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Sahloul

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (ACTUAL): June 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NigCOV1&2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: in the article publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No