Nigella Sativa in COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Dietary Supplement: Nigella sativa oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, open-label, controlled clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSO<br>Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days | Dietary Supplement: Nigella sativa oil<br>* Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days<br>|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Clinical Recovery Within 14 Days After Randomization | The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms) | Day 14 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Nigella sativa, Herbal