Nigella Sativa in COVID-19

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    King Abdulaziz University
Updated on 19 February 2024
antiviral drugs
pneumonia
PCR test
covid-19
upper respiratory infection
SARS
respiratory tract infection
coronavirus infection
respiratory infection
acute respiratory syndrome (sars)

Summary

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 hospitalized adult patients diagnosed with 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.

Details
Condition Covid 19, SARS-CoV-2
Age 18-80 years
Treatment Nigella sativa
Clinical Study IdentifierNCT04401202
SponsorKing Abdulaziz University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with COVID19 upper respiratory tract infection 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
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