Nigella Sativa in COVID-19

Phase 2

Completed

• Conditions: COVID-19; SARS-CoV-2
• Interventions: Dietary Supplement: Nigella sativa oil

• Registration Number: NCT04401202
• Lead Sponsor: King Abdulaziz University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Results First Submitted: 2021-05-23
• Results First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Results First Posted: 2021-05-26
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSO	Nigella sativa oil	Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Recovery Within 14 Days After Randomization	Day 14	The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)

Secondary Outcome Measures

Name	Time	Method
Duration of Each Symptom	Day 14	Duration of each symptom in days
Hospital Admission Due to Disease Complications	Day 14	High severity of COVID-19 (mild cases does not require hospitalization)
The Number of Days to Recovery	Day 14	The number of days to recovery (number of symptomatic days)
Side Effects	Day 14	Side effects from the investigational treatment

Trial Locations

Locations (1)

King Abdulaziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia