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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553705
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : July 19, 2022
Sponsor:
Collaborators:
Maternity and Children Hospital, Makkah
University of Arizona
Information provided by (Responsible Party):
Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 17, 2020
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE September 20, 2020
Actual Primary Completion Date November 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Clinical improvement [ Time Frame: 30 Days ]
    Time to Clinical recovery
  • Recovery rate from positive to negative swaps [ Time Frame: 14 Days ]
    Percentage of patients returned to negative swaps of COVID-19
  • Fever to normal temperature in days [ Time Frame: 15 Days ]
    Number of days for fever remission T=37.5°C
  • 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
  • Length of hospitalization [ Time Frame: 10 Days ]
    Number of days for hospitalization
  • (PCR levels) polymerase chain reaction assay levels [ Time Frame: 10 Days ]
    Change of (PCR levels) > 50% in comparison with PCR levels at the admission
  • Respiratory indexes [ Time Frame: 10 Days ]
    P O2/Fi O2 which reflects patients' oxygen saturation
  • C-reactive protein mg/L [ Time Frame: 25 Days ]
    C-reactive protein milligrams per deciliter correlated with inflammation
  • Serum Ferritin ng/ml [ Time Frame: 25 Days ]
    Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
  • Lactic acid dehydrogenase U/L [ Time Frame: 25 Days ]
    Lactic acid dehydrogenase unit per litter correlated with illness severity
  • leukocytes count μl [ Time Frame: 30 Days ]
    leukocytes in microliter correlated with mortality
  • Lipid profile [LDL, HDL, Total cholesterol ] [ Time Frame: 14 Days ]
    Mg/dl correlated with lipid peroxidation that linked to oxidative stress
  • total plasma antioxidant capacity [ Time Frame: 14 Days ]
    Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • Clinical improvement [ Time Frame: 30 Days ]
    Time to Clinical recovery
  • Recovery rate from positive to negative swaps [ Time Frame: 14 Days ]
    Percentage of patients returned to negative swaps of COVID-19
  • Fever to normal temperature in days [ Time Frame: 15 Days ]
    Number of days for fever remission T=37.5°C
  • 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
  • Length of hospitalization [ Time Frame: 10 Days ]
    Number of days for hospitalization
  • (PCR levels) polymerase chain reaction assay levels [ Time Frame: 10 Days ]
    Reduction of (PCR levels) > 50% in comparison with PCR levels at the admission
  • Respiratory indexes [ Time Frame: 10 Days ]
    P O2/Fi O2 which reflects patients' oxygen saturation
  • C-reactive protein mg/L [ Time Frame: 25 Days ]
    C-reactive protein milligrams per deciliter correlated with inflammation
  • Serum Ferritin ng/ml [ Time Frame: 25 Days ]
    Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
  • Lactic acid dehydrogenase U/L [ Time Frame: 25 Days ]
    Lactic acid dehydrogenase unit per litter correlated with illness severity
  • leukocytes count μl [ Time Frame: 30 Days ]
    leukocytes in microliter correlated with mortality
  • Lipid profile [LDL, HDL, Total cholesterol ] [ Time Frame: 14 Days ]
    Mg/dl correlated with lipid peroxidation that linked to oxidative stress
  • total plasma antioxidant capacity [ Time Frame: 14 Days ]
    Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)
Official Title  ICMJE Impact of Different Treatment Modalities on Immunity Against COVID-19
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Immunodeficiency
Intervention  ICMJE
  • Drug: Omega 3/Nigella Sativa Oil

    Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)

    Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone

  • Drug: Omega 3/Nigella Sativa Oil/Indian Costus

    Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)

    Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone

    Indian Costus supplements

  • Drug: Omega 3/Nigella Sativa Oil/Quinine pills

    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)

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

    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)

  • Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice

    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

  • Drug: Active Comparator
    Standard protocol care of COVID-19 infection
Study Arms  ICMJE
  • Experimental: Omega-3/thymoquinone supplementation

    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

    Intervention: Drug: Omega 3/Nigella Sativa Oil
  • Experimental: Omega-3/thymoquinone / Indian Costus supplementation

    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

    Intervention: Drug: Omega 3/Nigella Sativa Oil/Indian Costus
  • Experimental: Omega-3/thymoquinone / 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

    Intervention: Drug: Omega 3/Nigella Sativa Oil/Quinine pills
  • Experimental: Omega-3/thymoquinone / 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

    Intervention: Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule
  • Experimental: Omega-3/thymoquinone / 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

    Intervention: Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice
  • Active Comparator: Active Comparator: standard care
    The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
    Intervention: Drug: Active Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2022)
150
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2020)
200
Actual Study Completion Date  ICMJE December 4, 2021
Actual Primary Completion Date November 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04553705
Other Study ID Numbers  ICMJE TQ/Omega-3 on COVID-19
DOI: 10.31219/osf.io/u56fc ( Other Identifier: OSFPREPRINTS- MAY-4/2020 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University
Original Responsible Party Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University, Ph.D candidate Mohamed Medhat Abdelwahab Gamaleldin
Current Study Sponsor  ICMJE Beni-Suef University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Maternity and Children Hospital, Makkah
  • University of Arizona
Investigators  ICMJE
Study Director: IVO IBRAHAM Prof of Pharmacy, Clinical Translational Sciences], Ph.D University of Arizona, College of Pharmacy
Study Director: HASSAN Masmali [consultant of Pediatrics], M.D Maternity and Children hospital,Mecca, Saudi Arabia
Principal Investigator: MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate Beni-Suef University, Faculty of Pharmacy
Principal Investigator: SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate Beni-Suef University, Faculty of Pharmacy
PRS Account Beni-Suef University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP