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

Impact of Different Treatment Modalities on Immunity Against 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.

Study Overview

• Status: Completed
• Conditions: Covid19; Immunodeficiency
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Mecca, Makkah, Saudi Arabia
      • Maternity and Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	Time to Clinical recovery	30 Days
Recovery rate from positive to negative swaps	Percentage of patients returned to negative swaps of COVID-19	14 Days
Fever to normal temperature in days	Number of days for fever remission T=37.5°C	15 Days
Remission of lung inflammation in CT or X-ray	Number of days to report lungs recovery in chest X ray or CT	30 Days
Length of hospitalization	Number of days for hospitalization	10 Days
(PCR levels) polymerase chain reaction assay levels	Change of (PCR levels) > 50% in comparison with PCR levels at the admission	10 Days
Respiratory indexes	P O2/Fi O2 which reflects patients' oxygen saturation	10 Days
C-reactive protein mg/L	C-reactive protein milligrams per deciliter correlated with inflammation	25 Days
Serum Ferritin ng/ml	Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity	25 Days
Lactic acid dehydrogenase U/L	Lactic acid dehydrogenase unit per litter correlated with illness severity	25 Days
leukocytes count μl	leukocytes in microliter correlated with mortality	30 Days
Lipid profile [LDL, HDL, Total cholesterol ]	Mg/dl correlated with lipid peroxidation that linked to oxidative stress	14 Days
total plasma antioxidant capacity	Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA	14 Days

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: University of Arizona; Maternity and Children Hospital, Makkah
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): December 4, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; omega3; thymoquinone
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antiprotozoal Agents; Antiparasitic Agents; Neuromuscular Agents; Antimalarials; Muscle Relaxants, Central; Quinine
• Other Study ID Numbers: TQ/Omega-3 on COVID-19; DOI: 10.31219/osf.io/u56fc (Other Identifier: OSFPREPRINTS- MAY-4/2020)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No