Clinical trial NCT04401202: Nigella Sativa in COVID-19
Official title: Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19
SARS-CoV-2
Nigella sativa
Herbal
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label, controlled clinical study
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization
timeFrame: Day 14
Secondary outcomes:
measure: The Number of Days to Recovery
timeFrame: Day 14
measure: Duration of Each Symptom
timeFrame: Day 14
measure: Side Effects
timeFrame: Day 14
measure: Hospital Admission Due to Disease Complications
timeFrame: Day 14
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
References:
citation: Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa for the treatment of COVID-19: An open-label randomized controlled clinical trial. Complement Ther Med. 2021 Sep;61:102769. doi: 10.1016/j.ctim.2021.102769. Epub 2021 Aug 15.
citation: Koshak AE, Koshak EA, Mobeireek AF, Badawi MA, Wali SO, Malibary HM, Atwah AF, Alhamdan MM, Almalki RA, Madani TA. Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial. Trials. 2020 Aug 8;21(1):703. doi: 10.1186/s13063-020-04647-x.