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

NCT04914767 | Completed Phase 1

• 1 other identifier: NigCOV1&2
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Death Rate

  one month

• Rate of Requiring oxygen supplementation

  one month

• Rate of Hospiatalization

  one month

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Nigella DRUG

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.

Nigella

Placebo DRUG

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 Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (2)

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

Location

Riadh Boukef

Sahloul, Sousse Governorate, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Riadh Boukef, professor

  CHU Sahloul, Sousse, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: RCT

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 7, 2021
• Study Start: March 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)