Clinical trial NCT04553705: Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)
Official title: Impact of Different Treatment Modalities on Immunity Against COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Immunodeficiency
Keywords: COVID-19
omega3
thymoquinone
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Maternity and Children Hospital, Makkah
name: University of Arizona
First posted: 2020-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical improvement
timeFrame: 30 Days
measure: Recovery rate from positive to negative swaps
timeFrame: 14 Days
measure: Fever to normal temperature in days
timeFrame: 15 Days
measure: Remission of lung inflammation in CT or X-ray
timeFrame: 30 Days
measure: Length of hospitalization
timeFrame: 10 Days
measure: (PCR levels) polymerase chain reaction assay levels
timeFrame: 10 Days
measure: Respiratory indexes
timeFrame: 10 Days
measure: C-reactive protein mg/L
timeFrame: 25 Days
measure: Serum Ferritin ng/ml
timeFrame: 25 Days
measure: Lactic acid dehydrogenase U/L
timeFrame: 25 Days
measure: leukocytes count μl
timeFrame: 30 Days
measure: Lipid profile [LDL, HDL, Total cholesterol ]
timeFrame: 14 Days
measure: total plasma antioxidant capacity
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Maternity and Children hospital
state: Makkah
Study officials:
affiliation: University of Arizona, College of Pharmacy
name: IVO IBRAHAM Prof of Pharmacy, Clinical Translational Sciences], Ph.D
role: STUDY_DIRECTOR
affiliation: Maternity and Children hospital,Mecca, Saudi Arabia
name: HASSAN Masmali [consultant of Pediatrics], M.D
role: STUDY_DIRECTOR
affiliation: Beni-Suef University, Faculty of Pharmacy
name: MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Beni-Suef University, Faculty of Pharmacy
name: SHAIMAA M Nashat SAYED ABDELHALIM, Ph.D Candidate
role: PRINCIPAL_INVESTIGATOR
References: