Shervin Shokouhi
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Shervin Shokouhi has a total of 136 co-authors. Here are the top co-authors by number of shared publications:
- Ilad Alavi Darazam
Department of Infectious Diseases and Tropical Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
11 shared publications - Masoud Mardani
Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4 shared publications - Minoosh Shabani
Department of Infectious Diseases and Tropical Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3 shared publications - Ali Saffaei
Department of Pharmaceutical Care, Sepid Nikan Hospital, Tehran, Iran
2 shared publications Firouze Hatami
Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 shared publicationsLatif Gachkar
2 shared publications
Latest Publications
- Open Access
- 9 February 2025
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 20 (3)
Thyroid Dysfunction Among HIV-Positive Patients: A Cross-Sectional Study in Iran
Background: Thyroid dysfunction can arise from various factors affecting every level of the hypothalamic-pituitary-thyroid axis. The human immunodeficiency virus (HIV) has been implicated as an infectious agent contributing to the development of endocrine disorders, including thyroid-related conditions. Objectives: This study aimed to elucidate the correlation between HIV infection, concurrent comorbidities, and thyroid diseases. Methods: Between January 2020 and May 2022, 70 HIV-positive patients within the HIV clinic at Loghman-Hakim Hospital were included in this study. In addition to history and physical examinations, serum thyroid function tests, including thyroid-stimulating hormone (TSH), thyroxine (T4), Free T4, triiodothyronine (T3), T3 Reuptake, and anti-TPO antibody, were measured in all patients. Results: Among the 70 patients, thyroid dysfunction was identified in 27.1% of the patients. Subclinical hypothyroidism was the most common finding, affecting 15.7% of the patients. Primary hypothyroidism and isolated elevated anti-TPO antibody levels with normal thyroid function were observed in 4% of patients. Thyroid dysregulation was more prevalent in females (36% vs. 22.2%), and most patients were receiving ART treatment. Conclusions: The incidence of thyroid abnormalities among people living with HIV remains a topic of debate and variability across different societies. However, emerging evidence suggests that factors such as age, gender, and the quality of treatment may play significant roles in the development of thyroid dysfunction in this population.
- 9 February 2025
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 20 (3)
Open AccessThyroid Dysfunction Among HIV-Positive Patients: A Cross-Sectional Study in Iran
Background: Thyroid dysfunction can arise from various factors affecting every level of the hypothalamic-pituitary-thyroid axis. The human immunodeficiency virus (HIV) has been implicated as an infectious agent contributing to the development of endocrine disorders, including thyroid-related conditions. Objectives: This study aimed to elucidate the correlation between HIV infection, concurrent comorbidities, and thyroid diseases. Methods: Between January 2020 and May 2022, 70 HIV-positive patients within the HIV clinic at Loghman-Hakim Hospital were included in this study. In addition to history and physical examinations, serum thyroid function tests, including thyroid-stimulating hormone (TSH), thyroxine (T4), Free T4, triiodothyronine (T3), T3 Reuptake, and anti-TPO antibody, were measured in all patients. Results: Among the 70 patients, thyroid dysfunction was identified in 27.1% of the patients. Subclinical hypothyroidism was the most common finding, affecting 15.7% of the patients. Primary hypothyroidism and isolated elevated anti-TPO antibody levels with normal thyroid function were observed in 4% of patients. Thyroid dysregulation was more prevalent in females (36% vs. 22.2%), and most patients were receiving ART treatment. Conclusions: The incidence of thyroid abnormalities among people living with HIV remains a topic of debate and variability across different societies. However, emerging evidence suggests that factors such as age, gender, and the quality of treatment may play significant roles in the development of thyroid dysfunction in this population.
- Open Access
- 18 September 2024
- Published by Elsevier in Journal of Global Antimicrobial Resistance
- Vol. 39, 159-169
The frequency of AmpC overproduction, OprD downregulation and OprM efflux pump expression in Pseudomonas aeruginosa: A comprehensive meta-analysis
- 18 September 2024
- Published by Elsevier in Journal of Global Antimicrobial Resistance
- Vol. 39, 159-169
Open AccessThe frequency of AmpC overproduction, OprD downregulation and OprM efflux pump expression in Pseudomonas aeruginosa: A comprehensive meta-analysis
- Open Access
- 5 April 2023
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 18 (1)
Treatment of Patients with Community-Acquired Pneumonia: Official Practice Guideline of the Infectious Diseases and Tropical Medicine Research Center Advisory Committee
Context: Community-acquired pneumonia (CAP) refers to pneumonia attained outside the hospital or less than 48 hours before admission, which is a significant cause of mortality and morbidity, especially in major comorbidities and older age. Several microorganisms contribute to developing CAP, primarily Streptococcus pneumonia, Haemophilus influenza, Moraxella catarrhalis, and atypical pathogens, e.g., Mycoplasma pneumonia. The incidence of these microorganisms depends on outpatient or inpatient settings. Administering appropriate treatment among available antibiotics is a critical issue affecting patient survival. Methods: With a multidisciplinary panel expert, this document offers evidence-based recommendations for managing CAP in Iran. Results: The document evaluated the availability of antimicrobial agents and local antibiotic resistance patterns based on 94 relevant published studies from Google Scholar, Scopus, PubMed, Scientific Information Database (SID), Iran Medex, Iran doc, Mag Iran, PubMed, and expert opinions. Conclusions: The panel addressed two main parts of rational recommendations for managing outpatients or hospitalized patients with CAP.
- 5 April 2023
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 18 (1)
Open AccessTreatment of Patients with Community-Acquired Pneumonia: Official Practice Guideline of the Infectious Diseases and Tropical Medicine Research Center Advisory Committee
Context: Community-acquired pneumonia (CAP) refers to pneumonia attained outside the hospital or less than 48 hours before admission, which is a significant cause of mortality and morbidity, especially in major comorbidities and older age. Several microorganisms contribute to developing CAP, primarily Streptococcus pneumonia, Haemophilus influenza, Moraxella catarrhalis, and atypical pathogens, e.g., Mycoplasma pneumonia. The incidence of these microorganisms depends on outpatient or inpatient settings. Administering appropriate treatment among available antibiotics is a critical issue affecting patient survival. Methods: With a multidisciplinary panel expert, this document offers evidence-based recommendations for managing CAP in Iran. Results: The document evaluated the availability of antimicrobial agents and local antibiotic resistance patterns based on 94 relevant published studies from Google Scholar, Scopus, PubMed, Scientific Information Database (SID), Iran Medex, Iran doc, Mag Iran, PubMed, and expert opinions. Conclusions: The panel addressed two main parts of rational recommendations for managing outpatients or hospitalized patients with CAP.
- Open Access
- 30 June 2022
- Published by Brieflands in Jundishapur Journal of Microbiology
- Vol. 15 (6)
Bilateral Prosthetic Knee Joint Infection Caused by Brucella melitensis: A Rare Case Report from Iran
Introduction: Brucella prosthetic joint infection is a rare condition. We report a case of bilateral prosthetic knee joint infection caused by Brucella melitensis, which was cured by prolonged antibiotic therapy without implant removal. Case Presentation: A 62-year-old woman was admitted to the Labbafinejad Hospital (Tehran, Iran), complaining of pain and swelling in her knee joints from two months ago. She was also suffering from intermittent fever and night sweats. She underwent bilateral total knee arthroplasty five years ago because of a severe degenerative joint disease. Agglutination tests (wright and 2-mercaptoethanol (2-ME)) were positive. Her knee joint fluid and blood cultures yielded B. melitensis. The polymerase chain reaction result from her knee joint fluid was positive for Brucella spp. The patient was cured after combination therapy with doxycycline, rifampin, and gentamicin. The prosthesis was retained due to the lack of loosening in radiography. Ten months after the treatment, the patient had no symptoms and could walk with no pain. Conclusions: Clinicians should consider brucellosis in the differential diagnosis of prosthetic joint infection in the endemic regions. They should also be aware that if patients have no sign of implant loosening, they can achieve favorable outcomes only by using antibiotics and with no need for implant removal.
- 30 June 2022
- Published by Brieflands in Jundishapur Journal of Microbiology
- Vol. 15 (6)
Open AccessBilateral Prosthetic Knee Joint Infection Caused by Brucella melitensis: A Rare Case Report from Iran
Introduction: Brucella prosthetic joint infection is a rare condition. We report a case of bilateral prosthetic knee joint infection caused by Brucella melitensis, which was cured by prolonged antibiotic therapy without implant removal. Case Presentation: A 62-year-old woman was admitted to the Labbafinejad Hospital (Tehran, Iran), complaining of pain and swelling in her knee joints from two months ago. She was also suffering from intermittent fever and night sweats. She underwent bilateral total knee arthroplasty five years ago because of a severe degenerative joint disease. Agglutination tests (wright and 2-mercaptoethanol (2-ME)) were positive. Her knee joint fluid and blood cultures yielded B. melitensis. The polymerase chain reaction result from her knee joint fluid was positive for Brucella spp. The patient was cured after combination therapy with doxycycline, rifampin, and gentamicin. The prosthesis was retained due to the lack of loosening in radiography. Ten months after the treatment, the patient had no symptoms and could walk with no pain. Conclusions: Clinicians should consider brucellosis in the differential diagnosis of prosthetic joint infection in the endemic regions. They should also be aware that if patients have no sign of implant loosening, they can achieve favorable outcomes only by using antibiotics and with no need for implant removal.
- Open Access
- 28 November 2021
- Published by Oxford University Press (OUP) in Journal of Antimicrobial Chemotherapy
- Vol. 77 (3) , 758-766
Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)
Background: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95–1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77–1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.
- 28 November 2021
- Published by Oxford University Press (OUP) in Journal of Antimicrobial Chemotherapy
- Vol. 77 (3) , 758-766
Open AccessEvaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)
Background: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95–1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77–1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.
- Open Access
- 30 June 2021
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 16 (2)
COVID-19 Vaccine and Hematopoietic Stem Cell Transplantation
Keywords Vaccine Hematopoietic Stem Cell Transplantation Transplantation COVID-19, SARS-COV-2
- 30 June 2021
- Published by Brieflands in Archives of Clinical Infectious Diseases
- Vol. 16 (2)
Open AccessCOVID-19 Vaccine and Hematopoietic Stem Cell Transplantation
Keywords Vaccine Hematopoietic Stem Cell Transplantation Transplantation COVID-19, SARS-COV-2
- Open Access
- 16 December 2020
- Published by Hindawi Limited in International Journal of Microbiology
- Vol. 2020, 1-7
Antipseudomonal β-Lactams Resistance in Iran
Over the last years, the mortality rate of Pseudomonas aeruginosa, which is one of the major reasons for severe infections, has been significantly increasing. This bacterium is highly resistant to many antibiotics, especially carbapenems, thanks to its complicated mechanism by which it can acquire exogenous genes. The purpose of this research is to have a review of empirical studies surveying the P. aeruginosa resistance to beta-lactams in Iran in order to investigate the most reliable methods by which the incidence of P. aeruginosa infections can be decreased and controlled. We performed a systematic review of all articles published from 2008 until 2018. Studies which did not address P. aeruginosa resistance to beta-lactams were excluded from the analysis. Studies with less than 10 cases were also excluded. Studies with more than ten cases, which did not have repetitive information, were taken into account for the final selection; 133 out of 893 articles were chosen. The resistance rate of P. aeruginosa among the articles was as follows: more than 72% of studies revealed >50% level of resistance to cefepime, followed by aztreonam (53.2%), ceftazidime (61%), piperacillin/tazobactam (54.5%), meropenem (48.3%), and imipenem (42.4%). The selection of empiric antipseudomonal antibiotics is absolutely uncertain and hazardous, and the risk of clinical failure may be more among cephalosporins and piperacillin-tazobactam as well as aztreonam. The results of this study illustrate that the methods enabling clinics to identify the bacterium resistance pattern and its genetic basis and to have the opportunity of empiric therapies through access to updated local data of antimicrobial susceptibility pattern are the most effective methods. However, the widespread usage of these approaches undoubtedly needs reliable molecular and nucleic acid-based devices, which are both affordable and available.
- 16 December 2020
- Published by Hindawi Limited in International Journal of Microbiology
- Vol. 2020, 1-7
Open AccessAntipseudomonal β-Lactams Resistance in Iran
Over the last years, the mortality rate of Pseudomonas aeruginosa, which is one of the major reasons for severe infections, has been significantly increasing. This bacterium is highly resistant to many antibiotics, especially carbapenems, thanks to its complicated mechanism by which it can acquire exogenous genes. The purpose of this research is to have a review of empirical studies surveying the P. aeruginosa resistance to beta-lactams in Iran in order to investigate the most reliable methods by which the incidence of P. aeruginosa infections can be decreased and controlled. We performed a systematic review of all articles published from 2008 until 2018. Studies which did not address P. aeruginosa resistance to beta-lactams were excluded from the analysis. Studies with less than 10 cases were also excluded. Studies with more than ten cases, which did not have repetitive information, were taken into account for the final selection; 133 out of 893 articles were chosen. The resistance rate of P. aeruginosa among the articles was as follows: more than 72% of studies revealed >50% level of resistance to cefepime, followed by aztreonam (53.2%), ceftazidime (61%), piperacillin/tazobactam (54.5%), meropenem (48.3%), and imipenem (42.4%). The selection of empiric antipseudomonal antibiotics is absolutely uncertain and hazardous, and the risk of clinical failure may be more among cephalosporins and piperacillin-tazobactam as well as aztreonam. The results of this study illustrate that the methods enabling clinics to identify the bacterium resistance pattern and its genetic basis and to have the opportunity of empiric therapies through access to updated local data of antimicrobial susceptibility pattern are the most effective methods. However, the widespread usage of these approaches undoubtedly needs reliable molecular and nucleic acid-based devices, which are both affordable and available.
- Open Access
- 9 November 2020
- Published by Maad Rayan Publishing Company in Immunopathologia Persa
- Vol. 7 (2) , e23
Clinical course and outcome in diabetic patients with COVID-19
Introduction: As diabetes is highly prevalent worldwide, understanding particular dimensions of COVID-19 infection in diabetic patients is of significant importance. Objectives: The present research aimed to evaluate the outcome of diabetic patients with COVID-19 infection, and the clinical and biochemical characteristics in survived and non-survived patients. Patients and Methods: The present single-center, cross-sectional study examined laboratory and clinical features of 160 patients with diabetes who had moderate to severe criteria. The obtained data were categorized as survived or non-survived patients and then we compared the clinical characteristics in two groups. Results: In this study, 160 diabetic patients (75 men and 85 women) admitted with moderate to severe Covid-19 were evaluated. The mean age of studied patients was 51-90 years old, with diabetes duration of 5 to 15 years. One hundred thirty-one patients (81.9%) survived, but twenty-nine patients (18.1%) did not survive. Regarding the comparison of symptoms, only the loss of consciousness on admission was higher in non- survived patients; however, a majority of the non-survivors have been admitted to ICU, 23(79.3%) and 26 (89.6%) needed invasive mechanical ventilation; in comparison to survived patients also had a shorter duration of hospital stay (5.5±5.1 versus 8.4±6.1days). Non–survivors more probably suffer from high blood pressure [23 (79.3%) patients versus 80 (61%) patients] and chronic kidney disease [20 (69%) patients versus 9 (6.9%) patients; PConclusion: Multifactorial parameters result in the poor prognosis in diabetic patients; therefore, it is critical for identifying the key clinical, as well as laboratory characteristics of COVID-19 cases that lead to severe disease and increase the risk of death.
- 9 November 2020
- Published by Maad Rayan Publishing Company in Immunopathologia Persa
- Vol. 7 (2) , e23
Open AccessClinical course and outcome in diabetic patients with COVID-19
Introduction: As diabetes is highly prevalent worldwide, understanding particular dimensions of COVID-19 infection in diabetic patients is of significant importance. Objectives: The present research aimed to evaluate the outcome of diabetic patients with COVID-19 infection, and the clinical and biochemical characteristics in survived and non-survived patients. Patients and Methods: The present single-center, cross-sectional study examined laboratory and clinical features of 160 patients with diabetes who had moderate to severe criteria. The obtained data were categorized as survived or non-survived patients and then we compared the clinical characteristics in two groups. Results: In this study, 160 diabetic patients (75 men and 85 women) admitted with moderate to severe Covid-19 were evaluated. The mean age of studied patients was 51-90 years old, with diabetes duration of 5 to 15 years. One hundred thirty-one patients (81.9%) survived, but twenty-nine patients (18.1%) did not survive. Regarding the comparison of symptoms, only the loss of consciousness on admission was higher in non- survived patients; however, a majority of the non-survivors have been admitted to ICU, 23(79.3%) and 26 (89.6%) needed invasive mechanical ventilation; in comparison to survived patients also had a shorter duration of hospital stay (5.5±5.1 versus 8.4±6.1days). Non–survivors more probably suffer from high blood pressure [23 (79.3%) patients versus 80 (61%) patients] and chronic kidney disease [20 (69%) patients versus 9 (6.9%) patients; PConclusion: Multifactorial parameters result in the poor prognosis in diabetic patients; therefore, it is critical for identifying the key clinical, as well as laboratory characteristics of COVID-19 cases that lead to severe disease and increase the risk of death.
- 6 November 2020
- Published by Taylor & Francis in Clinical Toxicology
- Vol. 59 (7) , 628-632
Early recovery of botulism: one decade of experience
Botulism is a rare but serious disease, which appears in different forms. In this study, we reviewed the clinical features, laboratory data, and outcomes of patients who referred to our tertiary ce...
- 6 November 2020
- Published by Taylor & Francis in Clinical Toxicology
- Vol. 59 (7) , 628-632
Early recovery of botulism: one decade of experience
Botulism is a rare but serious disease, which appears in different forms. In this study, we reviewed the clinical features, laboratory data, and outcomes of patients who referred to our tertiary ce...
- Open Access
- 26 October 2020
- Published by Springer Nature in Trials
- Vol. 21 (1) , 1-3
An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial
We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial. The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences. COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation. Primary outcome: 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: 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. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two 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. 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. Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra). Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20th 2020, and the end date was on September 4th 2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization. This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400, registered August 18, 2020 and first available online August 20, 2020). 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.
- 26 October 2020
- Published by Springer Nature in Trials
- Vol. 21 (1) , 1-3
Open AccessAn investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial
We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial. The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-β 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences. COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-β 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-β 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation. Primary outcome: 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: 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. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two 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. 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. Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra). Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20th 2020, and the end date was on September 4th 2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization. This study was registered with National Institutes of Health Clinical trials (www.clinicaltrials.gov; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400, registered August 18, 2020 and first available online August 20, 2020). 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.