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Article ; Online: Outcomes of polymyalgia rheumatica in real-world practice: a longitudinal cohort study.

Rahimi, Mehran / Esalatmanesh, Kamal / Daneshvar, Sara / Irvani, Seyed Sina Naghibi / Badali, Ahmadreza / Khabbazi, Alireza

Romanian journal of internal medicine = Revue roumaine de medecine interne

2024

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2024-03-12
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2015966-3
ISSN	2501-062X ; 0035-3973 ; 1582-3296
ISSN (online)	2501-062X
ISSN	0035-3973 ; 1582-3296
DOI	10.2478/rjim-2024-0009
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Article ; Online: Associations between Insulin Index and dietary insulin load with cardiometabolic phenotype in the AZAR cohort population in north-western Iran: a cross-sectionalstudy.

Faramarzi, Elnaz / Somi, Mohammad Hossein / Naghibi Irvani, Seyed Sina / Pourhashem, Nahid / Nourizadeh, Amir Mohammad

BMJ open

2023 Volume 13, Issue 5, Page(s) e068303

Abstract: Objectives: Hyperinsulinaemia and insulin resistance are proposed as contributors to the incidence of cardiometabolic phenotypes (CMPs) with unhealthy metabolic status. This study analysed the association between dietary insulin load (DIL) and Dietary ... ...

Abstract	Objectives: Hyperinsulinaemia and insulin resistance are proposed as contributors to the incidence of cardiometabolic phenotypes (CMPs) with unhealthy metabolic status. This study analysed the association between dietary insulin load (DIL) and Dietary Insulin Index (DII) with CMPs in the AZAR cohort population. Design: This study was a cross-sectional analysis of the AZAR Cohort Study, beginning in 2014 and continuing to this date. Setting: The AZAR cohort is a part of an Iranian screening programme named the Persian cohort and involves participants living in the Shabestar region, Iran for at least 9 months. Participants: A total of 15 006 participants agreed to partake in the study. We excluded participants with missing data (n=15), daily energy intake lower than 800 kcal (n=7) or higher than 8000 kcal (n=17), and cancer (n=85). Finally, 14 882 individuals remained. Primary and secondary outcome measures: The gathered information included the participants' demographic, dietary, anthropometric and physical activity data. Results: The frequency of DIL and DII significantly decreased from the first to fourth quartiles in metabolically unhealthy participants (p≤0.001). The mean values of DIL and DII were greater in metabolically healthy participants than in unhealthy ones (p<0.001). The results of the unadjusted model showed that the risks of unhealthy phenotypes in the fourth DIL quartile decreased by 0.21 (0.14-0.32) and 0.37 (0.33-0.43), respectively, compared with the first quartile. The same model showed the same risks for DII decreased by 0.18 (0.11-0.28) and 0.39 (0.34-0.45), respectively. The results in both genders were the same as all participants combined. Conclusions: DII and DIL were correlated with a decreased OR of unhealthy phenotypes. We suggest the reason may be either a lifestyle change in metabolically unhealthy participants or elevated insulin secretion not being as detrimental as previously thought. Further studies can confirm these speculations.
MeSH term(s)	Male ; Female ; Humans ; Insulin ; Iran/epidemiology ; Cohort Studies ; Cross-Sectional Studies ; Diet ; Phenotype ; Cardiovascular Diseases/epidemiology ; Body Mass Index ; Risk Factors
Chemical Substances	Insulin
Language	English
Publishing date	2023-05-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-068303
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Article ; Online: AZAR eye and vision cohort study.

Somi, Mohammad Hossein / Nikniaz, Zeinab / Ostadrahimi, Alireza / Naghibi Irvani, Seyed Sina / Nourizadeh, Amir Mohammad / Mirzaei, Mohammad / Alipour, Fateme / Jafari, Fatemeh / Faramarzi, Elnaz

Scientific reports

2023 Volume 13, Issue 1, Page(s) 7998

Abstract: According to World Health Organization (WHO), currently, 2.2 billion people are living with visual impairment worldwide, of which almost half could have been prevented. There are both modifiable and unmodifiable factors leading to visual disability and, ... ...

Abstract	According to World Health Organization (WHO), currently, 2.2 billion people are living with visual impairment worldwide, of which almost half could have been prevented. There are both modifiable and unmodifiable factors leading to visual disability and, ultimately, blindness. Several population-based studies in different parts of Iran have tried to determine these factors concerning their specific population and environment-related characteristics. AZAR Eye and Vision cohort is the second-largest cohort study in the whole country. AZAR Eye and Vision cohort is the ophthalmologic branch of AZAR cohort which is the largest eye cohort study in the country, which is trying to determine the prevalence and incidence of visual impairment, blindness, and other major ophthalmologic conditions and their associated risk factors in East Azerbaijan province located in Iran, a middle eastern country. A recently emerging phenomenon is the drying of the ultra-salty lake of Urmia located in the West Azerbaijan province which is a direct neighbor of our studied population and has caused recurrent salt storms in the immediate near areas. This phenomenon could adversely affect visual health via different conditions which our study will elucidate. The enrollment phase took place between 2014 and 2017 and 11,208 participants were enrolled out of 15,000 participants in the primary cohort. The resurvey phase will begin five years after the enrollment phase. In this phase, 30% of the participants are randomly selected to be reexamined and complete questionnaires. The participants showing any issues such as diabetes and being a glaucoma suspect will be included in the resurvey phase, too. Data categories gathered include demographics, lifestyle factors, past medical and drug histories, and a diet quality and quantity questionnaire including 130 edible items. Urine, hair, nail, and 25-ml blood samples, were collected from the participants. Then they were referred to an optometrist to complete an ophthalmologic questionnaire and undergo eye examination and lensometry. Then they underwent slit-lamp examinations and pictures were taken of the lens and fundus. People with suspected visual impairment were referred to an ophthalmology clinic. The data are processed and a four-level quality check is performed on each block. The most common visual impairment is cataracts. This study's most important aim is to evaluate the effect of local environmental and ethnic factors on eye diseases in this specific population.
MeSH term(s)	Humans ; Visually Impaired Persons ; Cohort Studies ; Visual Acuity ; Blindness/etiology ; Vision, Low/epidemiology ; Vision, Low/etiology ; Eye Diseases/complications ; Ocular Hypertension/complications ; Prevalence ; Vision Disorders/epidemiology ; Vision Disorders/complications
Language	English
Publishing date	2023-05-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-30212-y
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Article ; Online: A misdiagnosed case of blastic plasmacytoid dendritic cell neoplasm experiencing multiple recurrences who underwent allogeneic stem cell transplantation: a case report.

Salemi, Fateme / Mortazavizadeh, Seyed Mohammad Reza / Mirmoeeni, Seyyedmohammadsadeq / Azari Jafari, Amirhossein / Kosari, Farid / Naghibi Irvani, Seyed Sina

Journal of medical case reports

2021 Volume 15, Issue 1, Page(s) 292

Abstract: Background: Blastic plasmacytoid dendritic cell neoplasm represents a rare type of hematologic malignancy that often manifests itself through various skin lesions. It commonly affects the elderly male population. Lymph nodes, peripheral blood, and bone ... ...

Abstract	Background: Blastic plasmacytoid dendritic cell neoplasm represents a rare type of hematologic malignancy that often manifests itself through various skin lesions. It commonly affects the elderly male population. Lymph nodes, peripheral blood, and bone marrow involvement are the typical findings that justify its aggressive nature and dismal prognosis. On histopathological assessment, malignant cells share some similarities with blastic cells from the myeloid lineage that make immunohistochemistry staining mandatory for blastic plasmacytoid dendritic cell neoplasm diagnosis. Case presentation: A 35-year-old Asian man presented with cervical lymphadenopathy followed by an erythematous lesion on his left upper back. At first, the lesion was misdiagnosed as an infectious disease and made the patient receive two ineffective courses of azithromycin and clarithromycin. Six months later, besides persistent skin manifestations, he felt a cervical mass, which was misdiagnosed as follicular center cell lymphoma. Tumor recurrence following the chemoradiation questioned the diagnosis, and further pathologic assessments confirmed blastic plasmacytoid dendritic cell neoplasm. The second recurrence occurred 3 months after chemotherapy. Eventually, he received a bone marrow transplant after complete remission. However, the patient expired 3 months after transplant owing to the third recurrence and gastrointestinal graft versus host disease complications. Conclusions: Early clinical suspicion and true pathologic diagnosis play a crucial role in patients' prognosis. Moreover, allogenic bone marrow transplant should be performed with more caution in aggressive forms of blastic plasmacytoid dendritic cell neoplasm because of transplant side effects and high risk of cancer recurrence.
MeSH term(s)	Adult ; Aged ; Dendritic Cells ; Diagnostic Errors ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Neoplasm Recurrence, Local ; Skin Neoplasms/diagnosis ; Skin Neoplasms/therapy
Language	English
Publishing date	2021-05-23
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	2269805-X
ISSN	1752-1947 ; 1752-1947
ISSN (online)	1752-1947
ISSN	1752-1947
DOI	10.1186/s13256-021-02860-z
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Article ; Online: Prevalence of depressive symptoms and suicidal behaviors among Iranian high school students: A systematic review and meta-analysis.

Heidari, Mohammad Eghbal / Irvani, Seyed Sina Naghibi / Pourhoseingholi, Mohamad Amin / Takhtegahi, Mona Maleki / Beyranvand, Rezvane / Mardanparvar, Hossein / Hesami, Hamed / Ghavampour, Neda / Hatami, Hossein

Journal of affective disorders

2023 Volume 346, Page(s) 9–20

Abstract: Aim: The objective of this meta-analysis was to determine the prevalence of depressive symptoms and suicidal behaviors among high-school students in Iran.: Materials and methods: A comprehensive search strategy was conducted in the following original ...

Abstract	Aim: The objective of this meta-analysis was to determine the prevalence of depressive symptoms and suicidal behaviors among high-school students in Iran. Materials and methods: A comprehensive search strategy was conducted in the following original databases: PubMed, Web of Science (ISI), Scopus, Psycinfo, and national databases, including the Scientific Information Database (SID) and MagIran, from January 1988 through January 2023. Studies that reported the prevalence of depressive symptoms and suicidal behaviors among high school students in Iran were included. Two investigators extracted all relevant data independently. For deriving mean prevalence rates, random-effects meta-analyses were used. We assessed the quality of studies by the Joanna Briggs Institute (JBI). Results: Total of 67 studies (45,798 participants) were included in the syntheses on depressive symptoms and suicidal ideation. For depressive symptoms, the mean prevalence rate was 48 % (40 %, 55 %). 2804 participants were enrolled for assessing of the prevalence of suicide ideation, and the mean prevalence rate was 21 % (6 %, 36 %). The meta-analysis pooling of the prevalence estimates of suicide attempts was 18 % (15 %, 20 %). Conclusions: Approximately half of the high school students experience depressive symptoms and, astonishingly, one in five high school students experiences suicidal ideation, so to identify strategies for preventing and treating depressive symptoms and suicidal behaviors in this special population, further research and policymaking are urgently needed.
MeSH term(s)	Humans ; Suicidal Ideation ; Depression/epidemiology ; Iran/epidemiology ; Prevalence ; Students
Language	English
Publishing date	2023-10-18
Publishing country	Netherlands
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Review
ZDB-ID	135449-8
ISSN	1573-2517 ; 0165-0327
ISSN (online)	1573-2517
ISSN	0165-0327
DOI	10.1016/j.jad.2023.10.060
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Article ; Online: Prevalence of depression among amyotrophic lateral sclerosis (ALS) patients: A systematic review and meta-analysis

Heidari, Mohammad Eghbal / Nadali, Javad / Parouhan, Ali / Azarafraz, Mahdi / Tabatabai, Seyed Mohamadhasan / Irvani, Seyed Sina Naghibi / Eskandari, Fereshte / Gharebaghi, Alireza

Journal of affective disorders

2021 Volume 287, Page(s) 182–190

Abstract: Background: Amyotrophic lateral sclerosis (ALS) people have a high risk of severe mental disorders, like depression, which impacts their function, quality of life, and mobility. However, there are no estimates of depression based paper published. This ... ...

Abstract	Background: Amyotrophic lateral sclerosis (ALS) people have a high risk of severe mental disorders, like depression, which impacts their function, quality of life, and mobility. However, there are no estimates of depression based paper published. This study aimed conduct a systematic review and meta-analysis of the prevalence of depression in ALS patients around the world. Methods: PubMed/Medline, Web of science, Scopus, Embase, and Ovid are searched to identify papers that reporting the prevalence of depression. Studies are included in random-effects meta-analyses of the prevalence of depression. Subgroup analyses are performed on the severity of depression, instruments of depression, type of studies, and study regions. Results: 46 eligible studies reported prevalence of depression. The pooled prevalence of depression among ALS people was 34% (27%-41%). According to the severity of depression, mild, moderate, and severe depression were 29%, 16%, and 8%, respectively. For studies using BDI, PHQ, and HADS, the pooled prevalence of depression was 50%, 20%, and 15%, respectively. Conclusions: ALS people have a high prevalence of depression. The high prevalence of depression causes a reduction of quality of life and mobility. The study identifies a population group at high risk needing special attention in clinical practice.
MeSH term(s)	Amyotrophic Lateral Sclerosis/epidemiology ; Depressive Disorder ; Humans ; Prevalence ; Quality of Life
Language	English
Publishing date	2021-03-12
Publishing country	Netherlands
Document type	Journal Article ; Meta-Analysis ; Review ; Systematic Review
ZDB-ID	135449-8
ISSN	1573-2517 ; 0165-0327
ISSN (online)	1573-2517
ISSN	0165-0327
DOI	10.1016/j.jad.2021.03.015
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Article ; Online: A misdiagnosed case of blastic plasmacytoid dendritic cell neoplasm experiencing multiple recurrences who underwent allogeneic stem cell transplantation

Fateme Salemi / Seyed Mohammad Reza Mortazavizadeh / Seyyedmohammadsadeq Mirmoeeni / Amirhossein Azari Jafari / Farid Kosari / Seyed Sina Naghibi Irvani

Journal of Medical Case Reports, Vol 15, Iss 1, Pp 1-

a case report

2021 Volume 7

Abstract: Abstract Background Blastic plasmacytoid dendritic cell neoplasm represents a rare type of hematologic malignancy that often manifests itself through various skin lesions. It commonly affects the elderly male population. Lymph nodes, peripheral blood, ... ...

Abstract	Abstract Background Blastic plasmacytoid dendritic cell neoplasm represents a rare type of hematologic malignancy that often manifests itself through various skin lesions. It commonly affects the elderly male population. Lymph nodes, peripheral blood, and bone marrow involvement are the typical findings that justify its aggressive nature and dismal prognosis. On histopathological assessment, malignant cells share some similarities with blastic cells from the myeloid lineage that make immunohistochemistry staining mandatory for blastic plasmacytoid dendritic cell neoplasm diagnosis. Case presentation A 35-year-old Asian man presented with cervical lymphadenopathy followed by an erythematous lesion on his left upper back. At first, the lesion was misdiagnosed as an infectious disease and made the patient receive two ineffective courses of azithromycin and clarithromycin. Six months later, besides persistent skin manifestations, he felt a cervical mass, which was misdiagnosed as follicular center cell lymphoma. Tumor recurrence following the chemoradiation questioned the diagnosis, and further pathologic assessments confirmed blastic plasmacytoid dendritic cell neoplasm. The second recurrence occurred 3 months after chemotherapy. Eventually, he received a bone marrow transplant after complete remission. However, the patient expired 3 months after transplant owing to the third recurrence and gastrointestinal graft versus host disease complications. Conclusions Early clinical suspicion and true pathologic diagnosis play a crucial role in patients’ prognosis. Moreover, allogenic bone marrow transplant should be performed with more caution in aggressive forms of blastic plasmacytoid dendritic cell neoplasm because of transplant side effects and high risk of cancer recurrence.
Keywords	Blastic plasmacytoid dendritic cell neoplasm ; Immunohistochemistry ; Recurrence ; Graft versus host disease ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19

Seyed Sina Naghibi Irvani / Maryam Golmohammadi / Mohamad Amin Pourhoseingholi / Shervin Shokouhi / Ilad Alavi Darazam

Trials, Vol 21, Iss 1, Pp 1-

structured summary of a study protocol for a randomized controlled trial

2020 Volume 3

Abstract: Abstract Objectives We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill. Trial design This is a ...

Abstract	Abstract Objectives We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill. Trial design This is a single center, open label, randomized, controlled, parallel group, clinical trial that will be conducted at Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences. Participants Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9th to April 14th 2020. Patients will be randomly assigned to the intervention groups or the control group with the following eligibility criteria: ≥ 18 years of age AND (oxygen saturation (SPO2) ≤ 93% OR respiratory rate ≥ 24) AND at least one of the following: Contactless infrared forehead thermometer temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission, and time of onset of the symptoms should be acute (Days ≤ 14). Although Hydroxychloroquine will be administered in a single dose, patients with heart problems (prolonged QT or PR intervals, second- or third-degree heart block, and arrhythmias including torsade de pointes) will be excluded. Other exclusion criteria include using drugs with potential interaction with Hydroxychloroquine + Lopinavir/Ritonavir, Interferon-β 1a, Interferon-β 1b, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results and refusal to participate. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services. Intervention and comparator COVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will ...
Keywords	COVID-19 ; SARS-COV-2 ; Randomized controlled trial ; Hydroxychloroquine + Lopinavir/Ritonavir ; Interferon-β 1a ; Interferon-β 1b ; Medicine (General) ; R5-920 ; covid19
Subject code	610
Language	English
Publishing date	2020-06-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prevalence of depression in older people with hip fracture: A systematic review and meta-analysis.

Heidari, Mohammad Eghbal / Naghibi Irvani, Seyed Sina / Dalvand, Pegah / Khadem, Mohaddeseh / Eskandari, Fereshte / Torabi, Fatemeh / Shahsavari, Hooman

International journal of orthopaedic and trauma nursing

2020 Volume 40, Page(s) 100813

Abstract: Introduction: Hip fracture disrupts general health and is one of the most common physical injuries in the elderly. Depression is the most common mood disorder in older people and one of the main complications of hip fractures.: Aim and methods: We ... ...

Abstract	Introduction: Hip fracture disrupts general health and is one of the most common physical injuries in the elderly. Depression is the most common mood disorder in older people and one of the main complications of hip fractures. Aim and methods: We conducted a meta-analysis to estimate the prevalence of depression in older people with hip fractures. Relevant literature published until July 2019 was obtained and screened according to established inclusion criteria. Two researchers independently carried out quality assessment and data extraction before the meta-analysis. We calculated proportions with 95% confidence intervals (CI). To investigate the sources of heterogeneity, we performed subgroup analyses based on study design, follow-up duration, type of fracture, and gender. Results: Twenty-seven studies with a combined sample size of 11958 were included. The overall prevalence of depression in older people with hip fracture was 23% (95% CI: 0.18 to 0.29). The lowest and highest prevalence of depression was in Asia (0.19) and America (0.27) respectively. Conclusion: In this systematic review and meta-analysis the estimated prevalence of depression among older hip fracture patients was 23%. Further research is needed to identify strategies for preventing and treating mood disorders in this population.
Language	English
Publishing date	2020-08-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2537649-4
ISSN	1878-1292 ; 1878-1241
ISSN (online)	1878-1292
ISSN	1878-1241
DOI	10.1016/j.ijotn.2020.100813
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Article ; Online: Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial.

Irvani, Seyed Sina Naghibi / Golmohammadi, Maryam / Pourhoseingholi, Mohamad Amin / Shokouhi, Shervin / Darazam, Ilad Alavi

Trials

2020 Volume 21, Issue 1, Page(s) 473

Abstract: Objectives: We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill.: Trial design: This is a ... ...

Abstract	Objectives: We will investigate the effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen in COVID-19 in patients that have tested positive and are moderately to severely ill. Trial design: This is a single center, open label, randomized, controlled, parallel group, clinical trial that will be conducted at Loghman Hakim Medical Education Center in conjunction with Shahid Beheshti University of Medical Sciences. Participants: Sixty COVID-19 confirmed cases (using the RT-PCR test) will be enrolled in the trial between April 9 Intervention and comparator: COVID-19 confirmed patients will be randomly assigned to one of three groups, with 20 patients in each. The first group (Arm 1) will receive Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1a (Recigen), the second group (Arm 2) will be administered Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra) + Interferon-β 1b (Ziferon), and the control group (Arm 3) will be treated by Hydroxychloroquine + Lopinavir / Ritonavir (Kaletra). Main outcomes: Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. Secondary outcomes include mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. If any patient dies, we have reached an important secondary outcome. SpO2 Improvement between the last and first day of hospitalization, using pulse-oximetry. Duration of hospitalization from date of randomization until the date of hospital discharge or date of death from any cause, whichever comes first. Incidence of new mechanical ventilation uses from date of randomization until the last day of the study. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Statistical analysis will be performed by R version 3.6.1 software. We will use Kaplan-Meier to analyze the time to clinical improvement (compared with a log-rank test). Hazard ratios with 95% confidence intervals will be calculated using the Cox proportional-hazards model in crude and adjusted analysis. Randomization: Eligible patients will be randomly assigned in a 1:1:1 ratio to receive either Interferon Beta 1a, Interferon Beta 1b or standard care only. Patients will be randomly allocated to three therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases. Blinding (masking): The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement. Numbers to be randomized (sample size): Of the 60 patients who underwent randomization, 20 patients were assigned to receive Interferon beta-1a, 20 patients were assigned to receive Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone. Trial status: Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on 9 Trial registration: This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04343768, registered April 8, 2020 and first available online April 13, 2020). Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
MeSH term(s)	Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; COVID-19 ; Coronavirus Infections/diagnosis ; Coronavirus Infections/drug therapy ; Coronavirus Infections/virology ; Drug Combinations ; Drug Therapy, Combination ; Host-Pathogen Interactions ; Humans ; Hydroxychloroquine/therapeutic use ; Interferon beta-1a/adverse effects ; Interferon beta-1a/therapeutic use ; Interferon beta-1b/adverse effects ; Interferon beta-1b/therapeutic use ; Iran ; Lopinavir/therapeutic use ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/virology ; Randomized Controlled Trials as Topic ; Ritonavir/therapeutic use ; SARS-CoV-2 ; Severity of Illness Index ; Time Factors ; Treatment Outcome
Chemical Substances	Antiviral Agents ; Drug Combinations ; lopinavir-ritonavir drug combination ; Interferon beta-1b (145155-23-3) ; Lopinavir (2494G1JF75) ; Hydroxychloroquine (4QWG6N8QKH) ; Ritonavir (O3J8G9O825) ; Interferon beta-1a (XRO4566Q4R)
Keywords	covid19
Language	English
Publishing date	2020-06-03
Publishing country	England
Document type	Clinical Trial Protocol ; Letter
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-020-04382-3
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