COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, SARS-CoV-2, Nigella sativa, Herbal
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.
Interventions
DIETARY_SUPPLEMENTNigella sativa oil
Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, open-label, controlled clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Recovery Within 14 Days After Randomization | 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
| Measure | Time frame | Description |
|---|---|---|
| The Number of Days to Recovery | Day 14 | The number of days to recovery (number of symptomatic days) |
| Duration of Each Symptom | Day 14 | Duration of each symptom in days |
| Side Effects | Day 14 | Side effects from the investigational treatment |
| Hospital Admission Due to Disease Complications | Day 14 | High severity of COVID-19 (mild cases does not require hospitalization) |
Countries
Saudi Arabia
Participant flow
Pre-assignment details
233 cases assessed for eligibility. 50 cases were excluded because; Asymptomatic (31), Pregnant (3), Declined to participate (n= 7), Failed communication (n= 9)
Participants by arm
| Arm | Count |
|---|---|
| Nigella Sativa Oil Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days | 87 |
| Control Standard of care | 86 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Hospitalized | 4 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Control | Total | Nigella Sativa Oil |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 10 |
| BMI | 27.2 kg/m^2 STANDARD_DEVIATION 5.5 | 27.1 kg/m^2 STANDARD_DEVIATION 5.7 | 27.1 kg/m^2 STANDARD_DEVIATION 6.1 |
| Pre-enrollment days | 4 days STANDARD_DEVIATION 3.1 | 3.7 days STANDARD_DEVIATION 2.6 | 3.5 days STANDARD_DEVIATION 2.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 39 Participants | 80 Participants | 41 Participants |
| Sex: Female, Male Male | 47 Participants | 93 Participants | 46 Participants |
| Smoker | 9 Participants | 21 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 86 |
| other Total, other adverse events | 3 / 87 | 0 / 86 |
| serious Total, serious adverse events | 0 / 87 | 0 / 86 |
Outcome results
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)
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nigella Sativa Oil | Percentage of Participants With Clinical Recovery Within 14 Days After Randomization | 54 Participants |
| Control | Percentage of Participants With Clinical Recovery Within 14 Days After Randomization | 31 Participants |
p-value: 0.001Chi-squared
Secondary
Duration of Each Symptom
Duration of each symptom in days
Time frame: Day 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nigella Sativa Oil | Duration of Each Symptom | Anosmia | 8.5 days | Standard Deviation 3.9 |
| Nigella Sativa Oil | Duration of Each Symptom | Runny nose | 2.5 days | Standard Deviation 1.6 |
| Nigella Sativa Oil | Duration of Each Symptom | Loss of appetite | 3.5 days | Standard Deviation 2.9 |
| Nigella Sativa Oil | Duration of Each Symptom | Chills | 2.1 days | Standard Deviation 1 |
| Control | Duration of Each Symptom | Chills | 4.9 days | Standard Deviation 3.4 |
| Control | Duration of Each Symptom | Anosmia | 10.4 days | Standard Deviation 3.6 |
| Control | Duration of Each Symptom | Loss of appetite | 5.5 days | Standard Deviation 3.1 |
| Control | Duration of Each Symptom | Runny nose | 3.7 days | Standard Deviation 2.5 |
Secondary
Hospital Admission Due to Disease Complications
High severity of COVID-19 (mild cases does not require hospitalization)
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nigella Sativa Oil | Hospital Admission Due to Disease Complications | 0 Participants |
| Control | Hospital Admission Due to Disease Complications | 4 Participants |
Secondary
Side Effects
Side effects from the investigational treatment
Time frame: Day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nigella Sativa Oil | Side Effects | 3 Participants |
| Control | Side Effects | 0 Participants |
Secondary
The Number of Days to Recovery
The number of days to recovery (number of symptomatic days)
Time frame: Day 14
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nigella Sativa Oil | The Number of Days to Recovery | 11 days |
| Control | The Number of Days to Recovery | 14 days |