Nigella Sativa in COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401202
• Other study ID #: 266-20
• Status: Completed
• Phase: Phase 2
• Start date: May 21, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Dietary Supplement:
• Nigella sativa oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University Hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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