Phase 2
Completed N=183
Nigella Sativa in COVID-19
Source: ClinicalTrials.gov NCT04401202 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization — 54; 31 Participants — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Recovery Within 14 Days After Randomization |
54; 31 | 0.001 sig |
| SECONDARY The Number of Days to Recovery |
11; 14 | — |
| SECONDARY Duration of Each Symptom |
8.5; 10.4; 2.5; 3.7; 3.5; 5.5 | — |
| SECONDARY Side Effects |
3; 0 | — |
| SECONDARY Hospital Admission Due to Disease Complications |
0; 4 | — |
Eligibility 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) 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.
Data sourced from ClinicalTrials.gov (NCT04401202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.