Covid19, Immunodeficiency
Conditions
Keywords
COVID-19, omega3, thymoquinone
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.
Interventions
DRUGOmega 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
DRUGOmega 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
DRUGOmega 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)
DRUGOmega 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)
DRUGOmega 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
DRUGActive Comparator
Standard protocol care of COVID-19 infection
Sponsors
Maternity and Children Hospital, Makkah
University of Arizona
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 30 Days | Time to Clinical recovery |
| Recovery rate from positive to negative swaps | 14 Days | Percentage of patients returned to negative swaps of COVID-19 |
| Fever to normal temperature in days | 15 Days | Number of days for fever remission T=37.5°C |
| Remission of lung inflammation in CT or X-ray | 30 Days | Number of days to report lungs recovery in chest X ray or CT |
| Length of hospitalization | 10 Days | Number of days for hospitalization |
| (PCR levels) polymerase chain reaction assay levels | 10 Days | Change of (PCR levels) \> 50% in comparison with PCR levels at the admission |
| Respiratory indexes | 10 Days | P O2/Fi O2 which reflects patients' oxygen saturation |
| C-reactive protein mg/L | 25 Days | C-reactive protein milligrams per deciliter correlated with inflammation |
| 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 |
| 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 |
| total plasma antioxidant capacity | 14 Days | Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA |
Countries
Saudi Arabia
Outcome results
None listed