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

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hôpital Universitaire Sahloul

Criteria

Inclusion Criteria:

• Men and women at least 40 years old, able and willing to give informed consent;

• Ambulatory or hospitalized environment;

• Patient with dyspnea or with a positive gait test;

• 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, bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count;

• 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.