Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)

NCT04553705 — Phase 2 / Phase 3, Completed, 150 participants, Beni-Suef University

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Impact of Different Treatment Modalities on Immunity Against COVID-19

Registry	NCT04553705
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, sequential, masking: double, treatment
Enrollment	150 (Actual)
Sponsor	Beni-Suef University (Other); collaborators: Maternity and Children Hospital, Makkah, University of Arizona
Conditions	Covid19, Immunodeficiency
Interventions	Omega 3/Nigella Sativa Oil, Omega 3/Nigella Sativa Oil/Indian Costus, Omega 3/Nigella Sativa Oil/Quinine pills, Omega 3/Nigella Sativa Oil/Anise seed capsule, Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice, Active Comparator (Drug)
Dates	start 2020-09-20, primary completion 2020-11-04, completion 2021-12-04, first posted 2020-09-17, last updated 2025-09-23
Locations	1 site in Saudi Arabia

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Omega-3/thymoquinone supplementation	Experimental	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) per day for one month. In addition to the standard care
Omega-3/thymoquinone / Indian Costus supplementation	Experimental	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),(Indian Costus) per day for one month. In addition to the standard care
Omega-3/thymoquinone / Quinine pills	Experimental	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),(1g Quinine) per day for one month. In addition to the standard care
Omega-3/thymoquinone / Anise seed capsule	Experimental	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),(450mg anise seed) per day for one month. In addition to the standard care
Omega-3/thymoquinone / Deglycyrrhizinated Licorice	Experimental	Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice	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
Active Comparator: standard care	Active comparator	Drug: Active Comparator	The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia

Omega 3/Nigella Sativa Oil (Drug): Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
Omega 3/Nigella Sativa Oil/Indian Costus (Drug): 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/Nigella Sativa Oil/Quinine pills (Drug): 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/Nigella Sativa Oil/Anise seed capsule (Drug): 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/Nigella Sativa Oil/Deglycyrrhizinated Licorice (Drug): 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
Active Comparator (Drug): Standard protocol care of COVID-19 infection

+Outcome measures

Primary outcomes

Clinical improvement [30 Days]: Time to Clinical recovery
Recovery rate from positive to negative swaps [14 Days]: Percentage of patients returned to negative swaps of COVID-19
Fever to normal temperature in days [15 Days]: Number of days for fever remission T=37.5°C
Remission of lung inflammation in CT or X-ray [30 Days]: Number of days to report lungs recovery in chest X ray or CT
Length of hospitalization [10 Days]: Number of days for hospitalization
(PCR levels) polymerase chain reaction assay levels [10 Days]: Change of (PCR levels) > 50% in comparison with PCR levels at the admission
Respiratory indexes [10 Days]: P O2/Fi O2 which reflects patients' oxygen saturation
C-reactive protein mg/L [25 Days]: C-reactive protein milligrams per deciliter correlated with inflammation
Serum Ferritin ng/ml [25 Days]: Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
Lactic acid dehydrogenase U/L [25 Days]: Lactic acid dehydrogenase unit per litter correlated with illness severity
leukocytes count μl [30 Days]: leukocytes in microliter correlated with mortality
Lipid profile [LDL, HDL, Total cholesterol ] [14 Days]: Mg/dl correlated with lipid peroxidation that linked to oxidative stress
total plasma antioxidant capacity [14 Days]: Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA

+Eligibility

Sex: All, ages: 25 Years to 40 Years

Inclusion Criteria:

* Symptomatic with respiratory or systemic symptoms
* Positive nasopharyngeal swab for COVID-19
* CT imaging showing viral pneumonia
* Temperature 38°C
* Respiratory rate < 25 /min
* Oxygen saturation (pulse oximetry) >95%

Exclusion Criteria:

* Pregnant or breast feeding
* Hepatic failure Child-Pugh C
* Negative swab test of (SARS)-(CoV-2)
* Expected life is less than 24 hours
* End-stage lung disease

+Locations (1)

Facility	City	Country	Status
Maternity and Children hospital	Mecca, Mecca Region	Saudi Arabia

+Investigators

HASSAN Masmali [consultant of Pediatrics], M.D, Study director, Maternity and Children hospital,Mecca, Saudi Arabia
MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate, Principal investigator, Beni-Suef University, Faculty of Pharmacy
SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate, Principal investigator, Beni-Suef University, Faculty of Pharmacy