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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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