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
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Sep 2020
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedStudy Start
First participant enrolled
September 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2021
CompletedSeptember 23, 2025
September 1, 2025
2 months
September 15, 2020
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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
Study Arms (6)
Omega-3/thymoquinone supplementation
EXPERIMENTAL10 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
EXPERIMENTAL10 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
EXPERIMENTAL10 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
EXPERIMENTAL10 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
Omega-3/thymoquinone / Deglycyrrhizinated Licorice
EXPERIMENTAL10 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 COMPARATORThe standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
Interventions
Omega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
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 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 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 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Deglycyrrhizinated Licorice 800 mg
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beni-Suef Universitylead
- Maternity and Children Hospital, Makkahcollaborator
- University of Arizonacollaborator
Study Sites (1)
Maternity and Children hospital
Mecca, Mecca Region, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical researcher
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 17, 2020
Study Start
September 20, 2020
Primary Completion
November 4, 2020
Study Completion
December 4, 2021
Last Updated
September 23, 2025
Record last verified: 2025-09