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Nigella Sativa in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401202
Recruitment Status : Completed
First Posted : May 26, 2020
Results First Posted : May 26, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Abdulrahman E. Koshak, King Abdulaziz University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Dietary Supplement: Nigella sativa oil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label, controlled clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NSO
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
 Dietary Supplement: Nigella sativa oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
No Intervention: Control
Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Clinical Recovery Within 14 Days After Randomization [ Time Frame: 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 :
  1. The Number of Days to Recovery [ Time Frame: Day 14 ]
    The number of days to recovery (number of symptomatic days)

  2. Duration of Each Symptom [ Time Frame: Day 14 ]
    Duration of each symptom in days

  3. Side Effects [ Time Frame: Day 14 ]
    Side effects from the investigational treatment

  4. Hospital Admission Due to Disease Complications [ Time Frame: Day 14 ]
    High severity of COVID-19 (mild cases does not require hospitalization)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401202


Locations
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Saudi Arabia
King Abdulaziz University Hospital
Jeddah, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University
  Study Documents (Full-Text)

Documents provided by Dr Abdulrahman E. Koshak, King Abdulaziz University:
Study Protocol and Statistical Analysis Plan  [PDF] July 14, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Abdulrahman E. Koshak, Assistant Professor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT04401202    
Other Study ID Numbers: 266-20
First Posted: May 26, 2020    Key Record Dates
Results First Posted: May 26, 2021
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Abdulrahman E. Koshak, King Abdulaziz University:
COVID-19
SARS-CoV-2
Nigella sativa
Herbal
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases