Covid19COVID-19NCT04981743
The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Coronavirus Disease 2019 (COVID-19)
A study testing Nigella Sativa capsule twice daily in people with Covid19, run by Ain Shams University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Nigella Sativa capsule twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild-moderate COVID-19 according to the classification (Table 1)
- Adult (18 - 65 years old).
- Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2.
Who cannot join
- Patients with severe illness requiring admission to intensive care unit.
- Asymptomatic patients.
- Severe chronic kidney disease (i.e. estimated glomerular filtration rate < 30 mL/min) or end stage renal disease requiring dialysis
- Severe chronic liver disease (Alanine transaminase or Aspartate transaminase > 5 times the upper limit of normal).
- contraindications to any of the interventional drugs.
- Pregnancy or breast feeding.
- Allergy to any of the interventional.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Respiratory System specialized hospital at Kobry Elobba Military Medical hospitals.
Cairo, 012345
shimaa A. Aly, master, +201223844103, shimaa.aly90@gmail.com
Osama S. Beskales, Ass. Prof., +201223844103, shimaa.aly90@gmail.com
About this study
Official title: Evaluation of The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Management of Coronavirus Disease 2019 (COVID-19)
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 .
Read the 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.
- Conditions
- Covid19
- Being tested
- Nigella Sativa capsule twice daily
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella Sativa capsule twice dailyDietary supplement
Also called single dose of vitamin D3 tablet (2000 IU) once 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 .
| Study group | Role | What they receive |
|---|---|---|
| group 1 | No intervention | 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). |
| group 2 | Active comparator | Twenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy Receives: Dietary Supplement: Nigella Sativa capsule twice daily |
| group 3 | Active comparator | Twenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy Receives: Dietary Supplement: Nigella Sativa capsule twice daily |
| group 4 | Active comparator | 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. Receives: Dietary Supplement: Nigella Sativa capsule twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of Nigella Sativa and Vitamin D3 as a supplement for management of COVID-19 will be evaluated and recorded.
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
Measured: baseline and 14 days
Assessment of patient health status before and after treatment intervention for a period of 14 days will be done
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 .
Measured: baseline and 14 days
Secondary outcomes (2)
The recovery rate of patients, Intensive care unit admission rate of patients and the Length of hospital stay of the patients will be recorded
Length of hospital stay and number of patients need ICU admission due to deterioration of cases and progression of disease.
Measured: 14 days
The following laboratory testing will be performed at least twice during the study period:
- 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start21 Jul 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled Parallel Open label Randomized Clinical Trial .
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nagwa A. Sabri, professor, Study chair, Department of Clinical Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981743
- Sponsor's protocol ID
- supplement therapy in COVID-19
- Acronym
- COVID-19
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31986264Rodriguez-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.
PubMed 32179124Horowitz 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.
PubMed 32322478Montero-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.
PubMed 32269670Said SA, Abdulbaset A, El-Kholy AA, Besckales O, Sabri NA. The effect of Ni gella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial. Front Pharmacol. 2022 Nov 8;13:1011522. doi: 10.3389/fphar.2022.1011522. eCollection 2022.
PubMed 36425571
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Efficacy of Nigella Sativa Versus VitaminD3 as Supplement Therapy in Management of Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04981743
- Acronym / sponsor ID
- COVID-19 / supplement therapy in COVID-19
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Controlled Parallel Open label Randomized Clinical Trial .
| Arm | Type | Receives |
|---|---|---|
| group 1 | No intervention | –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). |
| group 2 | Active comparator | Dietary Supplement: Nigella Sativa capsule twice dailyTwenty five patients will be administered a single dose (900mg) of Nigella Sativa capsule twice daily plus standard therapy |
| group 3 | Active comparator | Dietary Supplement: Nigella Sativa capsule twice dailyTwenty five patients will be administered a single dose (2000 IU) of vitamin D3 tablet once daily plus standard therapy |
| group 4 | Active comparator | Dietary Supplement: Nigella Sativa capsule twice dailyTwenty 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mild-moderate COVID-19 according to the classification (Table 1)
- Adult (18 - 65 years old).
- Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2.
Key exclusion criteria (7 listed)
- Patients with severe illness requiring admission to intensive care unit.
- Asymptomatic patients.
- Severe chronic kidney disease (i.e. estimated glomerular filtration rate < 30 mL/min) or end stage renal disease requiring dialysis
- Severe chronic liver disease (Alanine transaminase or Aspartate transaminase > 5 times the upper limit of normal).
- contraindications to any of the interventional drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella Sativa capsule twice dailyAlso: single dose of vitamin D3 tablet (2000 IU) once dailyinvestigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 . | Dietary supplement | group 2, group 3, group 4 |
Primary outcome
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 .
2 secondary outcomes
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
The following laboratory testing will be performed at least twice during the study period:
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 32179124Rodriguez-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.
- Background: PubMed 32322478Horowitz 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.
- Background: PubMed 32269670Montero-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.
- Derived from this study: PubMed 36425571Said SA, Abdulbaset A, El-Kholy AA, Besckales O, Sabri NA. The effect of Ni gella sativa and vitamin D3 supplementation on the clinical outcome in COVID-19 patients: A randomized controlled clinical trial. Front Pharmacol. 2022 Nov 8;13:1011522. doi: 10.3389/fphar.2022.1011522. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagwa A. Sabri, professor study chair
Department of Clinical Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella Sativa capsule twice daily in people with Covid19, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amal A Elkholy (+201060355448, amalanas9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981743, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.