A Phase 2/3 interventional study of Omega 3/Nigella Sativa Oil and Omega 3/Nigella Sativa Oil/Indian Costus in Covid19 and Immunodeficiency, sponsored by Beni-Suef University. Completed at 1 site in Saudi Arabia. Open to participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Beni-Suef University · Phase 2/3, Interventional, and Treatment
The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc.
COVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment.
Based on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection.
Natural supplementations have many reported effects on the human health ranged from immunity boosting to effective antiviral effect. Omeg-3 as an example affect the human health by many mechanisms e.g. Anti-oxidant, immunity boosting agent. Moreover, Omega-3 exerts an antiviral effect on Flu virus by inhibiting influenza virus replication 1. On the other hand, black seed supplementation exerts a chelation effect on sickle cell anemia patients and inhibits Human Heme Metabolism 2. Moreover, black seed exerts an antiviral effect on the replication of old coronavirus and the expression of (TRP-genes) family 3. In addition, Omega-3 regulates the human immunity against bacterial and viral infections 4. During the past years, many natural sources exerts an antimalarial effect with perfect reported results 5.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \& 200-300mg DHA) (3% thymoquinone) per day for one month. In addition to the standard care
Drug: Omega 3/Nigella Sativa Oil
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \& 200-300mg DHA), (3% thymoquinone),(Indian Costus) per day for one month. In addition to the standard care
Drug: Omega 3/Nigella Sativa Oil/Indian Costus
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \& 200-300mg DHA), (3% thymoquinone),(1g Quinine) per day for one month. In addition to the standard care
Drug: Omega 3/Nigella Sativa Oil/Quinine pills
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \& 200-300mg DHA), (3% thymoquinone),(450mg anise seed) per day for one month. In addition to the standard care
Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA \& 200-300mg DHA), (3% thymoquinone),(Deglycyrrhizinated Licorice 800 mg ) per day for one month. In addition to the standard care
Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice
The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
Drug: Active Comparator
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Indian Costus supplements
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Quinine supplementation (1g Quinine)
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Anise seed supplementation (450mg anise seed)
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Deglycyrrhizinated Licorice 800 mg
Standard protocol care of COVID-19 infection
Clinical improvement
Time to Clinical recovery
Time frame: 30 Days
Recovery rate from positive to negative swaps
Percentage of patients returned to negative swaps of COVID-19
Time frame: 14 Days
Fever to normal temperature in days
Number of days for fever remission T=37.5°C
Time frame: 15 Days
Remission of lung inflammation in CT or X-ray
Number of days to report lungs recovery in chest X ray or CT
Time frame: 30 Days
Length of hospitalization
Number of days for hospitalization
Time frame: 10 Days
(PCR levels) polymerase chain reaction assay levels
Change of (PCR levels) \> 50% in comparison with PCR levels at the admission
Time frame: 10 Days
Respiratory indexes
P O2/Fi O2 which reflects patients' oxygen saturation
Time frame: 10 Days
C-reactive protein mg/L
C-reactive protein milligrams per deciliter correlated with inflammation
Time frame: 25 Days
Serum Ferritin ng/ml
Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
Time frame: 25 Days
Lactic acid dehydrogenase U/L
Lactic acid dehydrogenase unit per litter correlated with illness severity
Time frame: 25 Days
leukocytes count μl
leukocytes in microliter correlated with mortality
Time frame: 30 Days
Lipid profile [LDL, HDL, Total cholesterol ]
Mg/dl correlated with lipid peroxidation that linked to oxidative stress
Time frame: 14 Days
total plasma antioxidant capacity
Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
Time frame: 14 Days
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Beni-Suef University