Nigella Sativa in COVID-19

King Abdulaziz University

Status and phase

Completed

Phase 2

Conditions

COVID-19

SARS-CoV-2

Treatments

Dietary Supplement: Nigella sativa oil

Study type

Interventional

Funder types

Other

Identifiers

NCT04401202

266-20

Details and patient eligibility

About

Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.

Enrollment

183 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia
Adult (18 Years and above)
Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).
Understands and agrees to comply with planned study procedures.
Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.

Exclusion criteria

Patients with pneumonia or severe illness requiring admission to ICU.
Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30) or end stage renal disease requiring dialysis
Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal).
Pregnancy or breast feeding.
Anticipated transfer to another hospital which is not a study site within 72 hours.
Allergy to any study medication.