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

Phase 2

Completed

• Conditions: Immunodeficiency; Covid19
• Interventions: Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice; Drug: Active Comparator; 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

• Registration Number: NCT04553705
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-17
• Study Start: 2020-09-20
• Primary Completion: 2020-11-04
• Study Completion: 2021-12-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Omega-3/thymoquinone / Deglycyrrhizinated Licorice	Omega 3/Nigella Sativa Oil/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
Active Comparator: standard care	Active Comparator	The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
Omega-3/thymoquinone supplementation	Omega 3/Nigella Sativa Oil	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
Omega-3/thymoquinone / Indian Costus supplementation	Omega 3/Nigella Sativa Oil/Indian Costus	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
Omega-3/thymoquinone / Quinine pills	Omega 3/Nigella Sativa Oil/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
Omega-3/thymoquinone / Anise seed capsule	Omega 3/Nigella Sativa Oil/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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Maternity and Children hospital; 🇸🇦 Mecca, Makkah, Saudi Arabia