Clinical trial NCT04981743: The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19)
Official title: Evaluation of The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Management of Coronavirus Disease 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled Parallel Open label Randomized Clinical Trial .
Primary purpose: TREATMENT

Brief summary: The aim this study is to investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .

Detailed description: Corona-virus disease-19 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2, and this virus was first originated from Wuhan city of Hubei province of China spreading around the globe. The prominent symptoms of COVID-19 include fever, cough, dyspnea, and other symptoms noted in patients affected by COVID-19 that includes; chills, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell. In addition, the emergency warning signs of COVID-19 include difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse and bluish lips or face and the patients experiencing any of these signs should get immediate medical attention.

Herbal medicines are used by many people to try to improve their health upon the believe that "natural products" are always safe, and good for immunity based on the traditional knowledge .There is a potential of Nigella Sativa to treat the patients with COVID-19.

Nigella Sativa (NS), a widely used medicinal plant of the family Ranunculaceae ; commonly known as Black Cumin, has been shown to exert antiviral effects against a variety of viruses such as Mouse Cytomegalovirus and Hepatitis C Virus (HCV) . The components' antimicrobial properties against various microbes as well as their anti-inflammatory and immuno-modulatory effects have also been established .

The immune system defends the body from foreign, invading organisms, promoting protective immunity, while maintaining tolerance to self. The implications of vitamin deficiency on the immune system have become clearer in recent years, and in the context of vitamin D deficiency, the increased susceptibility to infection observed, especially in a genetically susceptible host to autoimmunity.

The classical actions of vitamin D are to promote calcium homeostasis, and to promote bone health. In humans, vitamin D is obtained from the diet, or synthesized in the skin as vitamin D is cutaneously produced after exposure to UV light, its synthesis is influenced by latitude, season, use of sun-block and skin pigmentation. Melanin absorbs UV radiation inhibiting the synthesis of vitamin D from 7-dihydrocholesterol. This initial vitamin D compound is inactive form; hydroxylation in the liver to form the active 25 hydroxy vitamin D3 (25 D). Vitamin D is the most reliable measurement of an individual's vitamin D status. It is converted in the kidney to the active compound 1,25 dihydroxy vitamin D (1,25 D) or calcidiol by 1-α-hydroxylase (CYP27B1), an enzyme which is stimulated by parathormone.

A principal defense against uncontrolled inflammation, and against viral infection in general, is provided by T regulatory lymphocytes (Tregs). Treg levels have been reported to be low in many COVID-19 patients, and can be increased by vitamin D supplementation. Low vitamin D levels have been associated with an increase in inflammatory cytokines, and a significantly increased risk of pneumonia, and viral upper respiratory tract infections.

Eligibility criteria: Inclusion Criteria:

1. Patients with mild-moderate COVID-19 according to the classification (Table 1)
2. Adult (18 - 65 years old).
3. Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2.

Exclusion Criteria:

1. Patients with severe illness requiring admission to intensive care unit.
2. Asymptomatic patients.
3. Severe chronic kidney disease (i.e. estimated glomerular filtration rate \< 30 mL/min) or end stage renal disease requiring dialysis
4. Severe chronic liver disease (Alanine transaminase or Aspartate transaminase \> 5 times the upper limit of normal).
5. contraindications to any of the interventional drugs.
6. Pregnancy or breast feeding.
7. Allergy to any of the interventional.

Primary outcomes:
measure: The safety and efficacy of Nigella Sativa and Vitamin D3 as a supplement for management of COVID-19 will be evaluated and recorded.
timeFrame: baseline and 14 days
measure: Assessment of patient health status before and after treatment intervention for a period of 14 days will be done
timeFrame: baseline and 14 days
Secondary outcomes:
measure: The recovery rate of patients, Intensive care unit admission rate of patients and the Length of hospital stay of the patients will be recorded
timeFrame: 14 days
measure: The following laboratory testing will be performed at least twice during the study period:
timeFrame: 14 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals.
Study officials:
affiliation: Department of Clinical Pharmacy
name: Nagwa A. Sabri, professor
role: STUDY_CHAIR
References:
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citation: Montero-Odasso M, Goens SD, Kamkar N, Lam R, Madden K, Molnar F, Speechley M, Stranges S. Canadian Geriatrics Society COVID-19 Recommendations for Older Adults. What Do Older Adults Need To Know? Can Geriatr J. 2020 Mar 1;23(1):149-151. doi: 10.5770/cgj.23.443. eCollection 2020 Mar. No abstract available.