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OpenTrials
Completed

NCT Number: NCT04401202

Nigella Sativa in COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King Abdulaziz University Hospital

Jeddah, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nigella sativa oil

Dietary Supplement

Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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