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

Primary Purpose

Covid19, Immunodeficiency

Status

Completed

Phase

Phase 2

Locations

Saudi Arabia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, omega3, thymoquinone

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Maternity and Children hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

Omega-3/thymoquinone supplementation

Omega-3/thymoquinone / Indian Costus supplementation

Omega-3/thymoquinone / Quinine pills

Omega-3/thymoquinone / Anise seed capsule

Omega-3/thymoquinone / Deglycyrrhizinated Licorice

Active Comparator: standard care

Arm 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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Clinical improvement

Time to Clinical recovery

Recovery rate from positive to negative swaps

Percentage of patients returned to negative swaps of COVID-19

Fever to normal temperature in days

Number of days for fever remission T=37.5°C

Remission of lung inflammation in CT or X-ray

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

Length of hospitalization

Number of days for hospitalization

(PCR levels) polymerase chain reaction assay levels

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

Respiratory indexes

P O2/Fi O2 which reflects patients' oxygen saturation

C-reactive protein mg/L

C-reactive protein milligrams per deciliter correlated with inflammation

Serum Ferritin ng/ml

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

Lactic acid dehydrogenase U/L

Lactic acid dehydrogenase unit per litter correlated with illness severity

leukocytes count μl

leukocytes in microliter correlated with mortality

Lipid profile [LDL, HDL, Total cholesterol ]

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

total plasma antioxidant capacity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04553705

First Posted

September 15, 2020

Last Updated

July 18, 2022

Sponsor

Beni-Suef University

Collaborators

Maternity and Children Hospital, Makkah, University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT04553705

Brief Title

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

Official Title

Impact of Different Treatment Modalities on Immunity Against COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 20, 2020 (Actual)

Primary Completion Date

November 4, 2020 (Actual)

Study Completion Date

December 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

Collaborators

Maternity and Children Hospital, Makkah, University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Immunodeficiency

Keywords

COVID-19, omega3, thymoquinone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega-3/thymoquinone supplementation

Arm Type

Experimental

Arm 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

Arm Title

Omega-3/thymoquinone / Indian Costus supplementation

Arm Type

Experimental

Arm Description

Arm Title

Omega-3/thymoquinone / Quinine pills

Arm Type

Experimental

Arm Description

Arm Title

Omega-3/thymoquinone / Anise seed capsule

Arm Type

Experimental

Arm Description

Arm Title

Omega-3/thymoquinone / Deglycyrrhizinated Licorice

Arm Type

Experimental

Arm Description

Arm Title

Active Comparator: standard care

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omega 3/Nigella Sativa Oil

Intervention Description

Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone

Intervention Type

Drug

Intervention Name(s)

Omega 3/Nigella Sativa Oil/Indian Costus

Intervention Description

Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Indian Costus supplements

Intervention Type

Drug

Intervention Name(s)

Omega 3/Nigella Sativa Oil/Quinine pills

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Omega 3/Nigella Sativa Oil/Anise seed capsule

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Active Comparator

Intervention Description

Standard protocol care of COVID-19 infection

Primary Outcome Measure Information:

Title

Clinical improvement

Description

Time to Clinical recovery

Time Frame

30 Days

Title

Recovery rate from positive to negative swaps

Description

Percentage of patients returned to negative swaps of COVID-19

Time Frame

14 Days

Title

Fever to normal temperature in days

Description

Number of days for fever remission T=37.5°C

Time Frame

15 Days

Title

Remission of lung inflammation in CT or X-ray

Description

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

Time Frame

30 Days

Title

Length of hospitalization

Description

Number of days for hospitalization

Time Frame

10 Days

Title

(PCR levels) polymerase chain reaction assay levels

Description

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

Time Frame

10 Days

Title

Respiratory indexes

Description

P O2/Fi O2 which reflects patients' oxygen saturation

Time Frame

10 Days

Title

C-reactive protein mg/L

Description

C-reactive protein milligrams per deciliter correlated with inflammation

Time Frame

25 Days

Title

Serum Ferritin ng/ml

Description

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

Time Frame

25 Days

Title

Lactic acid dehydrogenase U/L

Description

Lactic acid dehydrogenase unit per litter correlated with illness severity

Time Frame

25 Days

Title

leukocytes count μl

Description

leukocytes in microliter correlated with mortality

Time Frame

30 Days

Title

Lipid profile [LDL, HDL, Total cholesterol ]

Description

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

Time Frame

14 Days

Title

total plasma antioxidant capacity

Description

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

Time Frame

14 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

IVO IBRAHAM Prof of Pharmacy, Clinical Translational Sciences], Ph.D

Organizational Affiliation

University of Arizona, College of Pharmacy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

HASSAN Masmali [consultant of Pediatrics], M.D

Organizational Affiliation

Maternity and Children hospital,Mecca, Saudi Arabia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate

Organizational Affiliation

Beni-Suef University, Faculty of Pharmacy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate

Organizational Affiliation

Beni-Suef University, Faculty of Pharmacy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maternity and Children hospital

City

Mecca

State/Province

Makkah

Country

Saudi Arabia

12. IPD Sharing Statement

Learn more about this trial

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

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