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

Beni-Suef University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Immunodeficiency; Covid19

Treatments: Drug: Omega 3/Nigella Sativa Oil/Indian Costus; Drug: Active Comparator; Drug: Omega 3/Nigella Sativa Oil/Quinine pills; Drug: Omega 3/Nigella Sativa Oil; Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule; Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice

Study type: Interventional

Funder types: Other

Identifiers

NCT04553705

DOI: 10.31219/osf.io/u56fc (Other Identifier)

TQ/Omega-3 on COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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150 participants in 6 patient groups

Omega-3/thymoquinone supplementation

Experimental group

Description:

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

Treatment:

Drug: Omega 3/Nigella Sativa Oil

Omega-3/thymoquinone / Indian Costus supplementation

Experimental group

Description:

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

Treatment:

Drug: Omega 3/Nigella Sativa Oil/Indian Costus

Omega-3/thymoquinone / Quinine pills

Experimental group

Description:

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

Treatment:

Drug: Omega 3/Nigella Sativa Oil/Quinine pills

Omega-3/thymoquinone / Anise seed capsule

Experimental group

Description:

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

Treatment:

Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule

Omega-3/thymoquinone / Deglycyrrhizinated Licorice

Experimental group

Description:

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

Treatment:

Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice

Active Comparator: standard care

Active Comparator group

Description:

The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia

Treatment:

Drug: Active Comparator