Nigella Sativa in COVID-19

King Abdulaziz University183 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

183

Conditions

COVID-19 SARS-CoV-2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: Day 14

Secondary Outcomes

The Number of Days to Recovery

The number of days to recovery (number of symptomatic days)

Time frame: Day 14

Duration of Each Symptom

Duration of each symptom in days

Time frame: Day 14

Side Effects

Side effects from the investigational treatment

Time frame: Day 14

Hospital Admission Due to Disease Complications

High severity of COVID-19 (mild cases does not require hospitalization)

Time frame: Day 14

Nigella Sativa in COVID-19

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes