Covid19Phase 2/3NCT04553705
Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)
A Phase 2/3 study testing Omega 3/Nigella Sativa Oil, Omega 3/Nigella Sativa Oil/Indian Costus and Omega 3/Nigella Sativa Oil/Quinine pills in people with Covid19 and Immunodeficiency, run by Beni-Suef University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Covid19, Immunodeficiency
- What is being tested?
- Omega 3/Nigella Sativa Oil, Omega 3/Nigella Sativa Oil/Indian Costus and Omega 3/Nigella Sativa Oil/Quinine pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Sep 2020to 4 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Immunodeficiency
- Being tested
- 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
- Keywords
- COVID-19, omega3, thymoquinone
- Medical subject headings
- COVID-19, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3/Nigella Sativa OilDrug
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 CostusDrug
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 pillsDrug
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 capsuleDrug
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 LicoriceDrug
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 ComparatorDrug
Standard protocol care of COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Omega-3/thymoquinone supplementation | Experimental | 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 Receives: Drug: Omega 3/Nigella Sativa Oil |
| Omega-3/thymoquinone / Indian Costus supplementation | Experimental | 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 Receives: Drug: Omega 3/Nigella Sativa Oil/Indian Costus |
| Omega-3/thymoquinone / Quinine pills | Experimental | 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 Receives: Drug: Omega 3/Nigella Sativa Oil/Quinine pills |
| Omega-3/thymoquinone / Anise seed capsule | Experimental | 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 Receives: Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule |
| Omega-3/thymoquinone / Deglycyrrhizinated Licorice | Experimental | 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 Receives: Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice |
| Active Comparator: standard care | Active comparator | The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Time to Clinical recovery
Measured: 30 Days
Recovery rate from positive to negative swaps
Percentage of patients returned to negative swaps of COVID-19
Measured: 14 Days
Fever to normal temperature in days
Number of days for fever remission T=37.5°C
Measured: 15 Days
Remission of lung inflammation in CT or X-ray
Number of days to report lungs recovery in chest X ray or CT
Measured: 30 Days
Length of hospitalization
Number of days for hospitalization
Measured: 10 Days
(PCR levels) polymerase chain reaction assay levels
Change of (PCR levels) > 50% in comparison with PCR levels at the admission
Measured: 10 Days
Respiratory indexes
P O2/Fi O2 which reflects patients' oxygen saturation
Measured: 10 Days
C-reactive protein mg/L
C-reactive protein milligrams per deciliter correlated with inflammation
Measured: 25 Days
Serum Ferritin ng/ml
Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
Measured: 25 Days
Lactic acid dehydrogenase U/L
Lactic acid dehydrogenase unit per litter correlated with illness severity
Measured: 25 Days
leukocytes count μl
leukocytes in microliter correlated with mortality
Measured: 30 Days
Lipid profile [LDL, HDL, Total cholesterol ]
Mg/dl correlated with lipid peroxidation that linked to oxidative stress
Measured: 14 Days
total plasma antioxidant capacity
Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start20 Sep 2020
- Primary completion4 Nov 2020
- Study completion4 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Maternity and Children Hospital, Makkah, University of Arizona
- Responsible party
- Principal investigator, Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University
- Investigators
- HASSAN Masmali [consultant of Pediatrics], M.D, Study director, Maternity and Children hospital,Mecca, Saudi ArabiaMOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate, Principal investigator, Beni-Suef University, Faculty of PharmacySHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate, Principal investigator, Beni-Suef University, Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553705
- Sponsor's protocol ID
- TQ/Omega-3 on COVID-19
- Other IDs
- DOI: 10.31219/osf.io/u56fc
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Treatment Modalities on Immunity Against COVID-19
- ClinicalTrials.gov ID
- NCT04553705
- Acronym / sponsor ID
- TQ/Omega-3 on COVID-19
- Conditions
- Covid19, Immunodeficiency
- Keywords
- COVID-19, omega3, thymoquinone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Maternity and Children Hospital, Makkah, University of Arizona
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Dec 2021 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Omega-3/thymoquinone supplementation | Experimental | Drug: Omega 3/Nigella Sativa Oil10 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 | Experimental | Drug: Omega 3/Nigella Sativa Oil/Indian Costus10 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 | Experimental | Drug: Omega 3/Nigella Sativa Oil/Quinine pills10 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 | Experimental | Drug: Omega 3/Nigella Sativa Oil/Anise seed capsule10 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 | Experimental | Drug: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice10 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 | Drug: Active ComparatorThe standard protocol care for COVID-19 approved from ministry of health at Saudi arabia |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Symptomatic with respiratory or systemic symptoms
- Positive nasopharyngeal swab for COVID-19
- CT imaging showing viral pneumonia
- Temperature 38°C
- Respiratory rate < 25 /min
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3/Nigella Sativa OilOmega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone | Drug | Omega-3/thymoquinone supplementation |
| Omega 3/Nigella Sativa Oil/Indian CostusOmega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Indian Costus supplements | Drug | Omega-3/thymoquinone / Indian Costus supplementation |
| Omega 3/Nigella Sativa Oil/Quinine pillsOmega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Quinine supplementation (1g Quinine) | Drug | Omega-3/thymoquinone / Quinine pills |
| Omega 3/Nigella Sativa Oil/Anise seed capsuleOmega-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) | Drug | Omega-3/thymoquinone / Anise seed capsule |
| Omega 3/Nigella Sativa Oil/Deglycyrrhizinated LicoriceOmega-3 supplementation 1000mg contains (300-400mg EPA \& 200-300mg DHA) Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone Deglycyrrhizinated Licorice 800 mg | Drug | Omega-3/thymoquinone / Deglycyrrhizinated Licorice |
| Active ComparatorStandard protocol care of COVID-19 infection | Drug | Active Comparator: standard care |
Primary outcome
Clinical improvement
Time frame: 30 Days
Time to Clinical recovery
Recovery rate from positive to negative swaps
Time frame: 14 Days
Percentage of patients returned to negative swaps of COVID-19
Fever to normal temperature in days
Time frame: 15 Days
Number of days for fever remission T=37.5°C
Remission of lung inflammation in CT or X-ray
Time frame: 30 Days
Number of days to report lungs recovery in chest X ray or CT
Length of hospitalization
Time frame: 10 Days
Number of days for hospitalization
(PCR levels) polymerase chain reaction assay levels
Time frame: 10 Days
Change of (PCR levels) > 50% in comparison with PCR levels at the admission
Respiratory indexes
Time frame: 10 Days
P O2/Fi O2 which reflects patients' oxygen saturation
C-reactive protein mg/L
Time frame: 25 Days
C-reactive protein milligrams per deciliter correlated with inflammation
Serum Ferritin ng/ml
Time frame: 25 Days
Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
Lactic acid dehydrogenase U/L
Time frame: 25 Days
Lactic acid dehydrogenase unit per litter correlated with illness severity
leukocytes count μl
Time frame: 30 Days
leukocytes in microliter correlated with mortality
Lipid profile [LDL, HDL, Total cholesterol ]
Time frame: 14 Days
Mg/dl correlated with lipid peroxidation that linked to oxidative stress
total plasma antioxidant capacity
Time frame: 14 Days
Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HASSAN Masmali [consultant of Pediatrics], M.D study director
Maternity and Children hospital,Mecca, Saudi Arabia
MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate principal investigator
Beni-Suef University, Faculty of Pharmacy
SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate principal investigator
Beni-Suef University, Faculty of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega 3/Nigella Sativa Oil, Omega 3/Nigella Sativa Oil/Indian Costus and Omega 3/Nigella Sativa Oil/Quinine pills in people with Covid19 and Immunodeficiency, run by Beni-Suef University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 30 Days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.