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

Covid19 Clinical Trial

Official title:

Impact of Different Treatment Modalities on Immunity Against COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553705
• Other study ID #: TQ/Omega-3 on COVID-19
• Secondary ID: DOI: 10.31219/os
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 20, 2020
• Est. completion date: December 4, 2021

Study information

• Verified date: July 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 4, 2021
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Immunodeficiency

Intervention

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
• 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
• 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)
• 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)
• 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
Standard protocol care of COVID-19 infection

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children hospital	Mecca	Makkah

Sponsors (3)

Lead Sponsor	Collaborator
Beni-Suef University	Maternity and Children Hospital, Makkah, University of Arizona

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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