The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19) (COVID-19)

• ClinicalTrials.gov Identifier: NCT04981743
• Recruitment Status: Recruiting
• First Posted: July 29, 2021
• Last Update Posted: July 29, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ain Shams University

Tracking Information

• First Submitted Date: July 9, 2021
• First Posted Date: July 29, 2021
• Last Update Posted Date: July 29, 2021
• Estimated Study Start Date: July 21, 2021
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 27, 2021)

• The safety and efficacy of Nigella Sativa and Vitamin D3 as a supplement for management of COVID-19 will be evaluated and recorded. [ Time Frame: baseline and 14 days ]
  The patient will be examined by the physician and the rate of occurrence of any of the following signs and symptoms on the participants will be reported:

  • Fever -Runny nose - Red swollen eyes
  • Fatigue - Shortening in breath - Skin rash
  • Cough - Body aches
  • Sore throat - Diarrhea, and/or Vomiting
  • Headache - Loss of taste and/or Smell
• Assessment of patient health status before and after treatment intervention for a period of 14 days will be done [ Time Frame: baseline and 14 days ]
  All patients will be evaluated during the study period (14 days) by undergoing PCR test after two days from absence of any clinical presentation, Then if the PCR is negative, the patient will be discharged from the hospital and complete his medication course at home.

  • If the result is positive then the patient will undergo another PCR testing on day 14 with no further follow up .

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 27, 2021)

• The recovery rate of patients, Intensive care unit admission rate of patients and the Length of hospital stay of the patients will be recorded [ Time Frame: 14 days ]
  Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease.
• The following laboratory testing will be performed at least twice during the study period: [ Time Frame: 14 days ]
  • C-Reactive Protein in mg/L.
  • Arterial Blood Gases[carbon dioxide partial pressure, oxygen partial pressure] in mm Hg.
  • Kidney function [serum creatinine, blood urea nitrogen ] in mg/dL.
  • liver function [ Alanine aminotransferase, Aspartate aminotransferase] in IU/L .
  • Erythrocyte sedimentation rate in mm/hr.
  • Complete blood picture.
  • Serum Ferritin in ug/L
  • international normalized ratio, prothrombin time, partial thromboplastin time in seconds
  • Polymerase chain reaction (PCR).
  • Computed tomography (CT) chest .

  Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Controlled Parallel Open label Randomized Clinical Trial .

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Covid19

Intervention

Dietary Supplement: Nigella Sativa capsule twice daily

investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .

Other Name: single dose of vitamin D3 tablet (2000 IU) once daily

Study Arms

• No Intervention: group 1
  Twenty five patients will be administered only the standard treatment regimen according to Ministry Of Health, and Population management protocol for COVID-19 patients (November 2020).
• Active Comparator: group 2
  Twenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy
  Intervention: Dietary Supplement: Nigella Sativa capsule twice daily
• Active Comparator: group 3
  Twenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy
  Intervention: Dietary Supplement: Nigella Sativa capsule twice daily
• Active Comparator: group 4
  Twenty five patients will be administered a single dose (900 mg) of Nigella Sativa capsule twice daily, and single dose of vitamin D3 tablet (2000 IU) once daily plus standard therapy.
  Intervention: Dietary Supplement: Nigella Sativa capsule twice daily

Publications *

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
• Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
• Horowitz RI, Freeman PR, Bruzzese J. Efficacy of glutathione therapy in relieving dyspnea associated with COVID-19 pneumonia: A report of 2 cases. Respir Med Case Rep. 2020 Apr 21;30:101063. doi: 10.1016/j.rmcr.2020.101063. eCollection 2020.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 27, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2021
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Amal A Elkholy; +201060355448; amalanas9@gmail.com

Contact: Shimaa A. Aly, Master; +201223844103; shimaa.aly90@gmail.com

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04981743
• Other Study ID Numbers: supplement therapy in COVID-19
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Nagwa A. Sabri, professor; Department of Clinical Pharmacy

• PRS Account: Ain Shams University
• Verification Date: July 2021