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Completed

NCT Number: NCT04553705

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

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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Key information

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Maternity and Children hospital

Mecca, Mecca Region, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Clinical improvement

    Time frame: 30 Days

    Time to Clinical recovery

  2. Recovery rate from positive to negative swaps

    Time frame: 14 Days

    Percentage of patients returned to negative swaps of COVID-19

  3. Fever to normal temperature in days

    Time frame: 15 Days

    Number of days for fever remission T=37.5°C

  4. Remission of lung inflammation in CT or X-ray

    Time frame: 30 Days

    Number of days to report lungs recovery in chest X ray or CT

  5. Length of hospitalization

    Time frame: 10 Days

    Number of days for hospitalization

  6. (PCR levels) polymerase chain reaction assay levels

    Time frame: 10 Days

    Change of (PCR levels) > 50% in comparison with PCR levels at the admission

  7. Respiratory indexes

    Time frame: 10 Days

    P O2/Fi O2 which reflects patients' oxygen saturation

  8. C-reactive protein mg/L

    Time frame: 25 Days

    C-reactive protein milligrams per deciliter correlated with inflammation

  9. Serum Ferritin ng/ml

    Time frame: 25 Days

    Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity

  10. Lactic acid dehydrogenase U/L

    Time frame: 25 Days

    Lactic acid dehydrogenase unit per litter correlated with illness severity

  11. leukocytes count μl

    Time frame: 30 Days

    leukocytes in microliter correlated with mortality

  12. Lipid profile [LDL, HDL, Total cholesterol ]

    Time frame: 14 Days

    Mg/dl correlated with lipid peroxidation that linked to oxidative stress

  13. total plasma antioxidant capacity

    Time frame: 14 Days

    Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Maternity and Children Hospital, Makkah
  • University of Arizona

Registry information

Official study title

Impact of Different Treatment Modalities on Immunity Against COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 17, 2020
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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