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

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ClinicalTrials.gov Identifier: NCT04553705
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 18, 2020
Sponsor:
Collaborators:
Maternity and Children Hospital, Makkah
University of Arizona
Information provided by (Responsible Party):
Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University

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.


Condition or disease Intervention/treatment Phase
Covid19 Immunodeficiency Drug: Omega 3/Nigella Sativa Oil Drug: Omega 3/Nigella Sativa Oil/Indian Costus Drug: Omega 3/Nigella Sativa Oil/Quinine pills Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice Drug: Active Comparator Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Impact of Different Treatment Modalities on Immunity Against COVID-19
Estimated Study Start Date : September 20, 2020
Estimated Primary Completion Date : November 4, 2020
Estimated Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Quinine

Arm Intervention/treatment
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

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


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

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


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

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)


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

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)


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

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


Active Comparator: Active Comparator: standard care
The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
Drug: Active Comparator
Standard protocol care of COVID-19 infection




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553705


Contacts
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Contact: MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate 00201110188554 dr.mohmedhat@gmail.com
Contact: SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate 00201110177667 drshimaa.nashat@gmail.com

Locations
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Saudi Arabia
Maternity and Children hospital Recruiting
Mecca, Makkah, Saudi Arabia
Contact: MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate    00201110188554    dr.mohmedhat@gmail.com   
Contact: SHAIMAA M NASHAT SAYED ABDELHALIM, Candidate    00201110177667    drshimaa.nashat@gmail.com   
Principal Investigator: MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate         
Principal Investigator: SHAIMAA M NASHAT SAYED ABDELHALIM, Ph.D Candidate         
Sub-Investigator: HASSAN Masmali, M.D         
Sponsors and Collaborators
Beni-Suef University
Maternity and Children Hospital, Makkah
University of Arizona
Investigators
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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
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Responsible Party: Mohamed Medhat Abdelwahab Gamaleldin, Clinical researcher, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04553705    
Other Study ID Numbers: TQ/Omega-3 on COVID-19
DOI: 10.31219/osf.io/u56fc ( Other Identifier: OSFPREPRINTS- MAY-4/2020 )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University:
COVID-19
omega3
thymoquinone
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents