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Abstract Background Many early signs of Surgical Site Infection (SSI) developed during the first thirty days after discharge remain inadequately recognized by patients. Hence, it is important to use interactive technologies for patient support in these times. It helps to diminish unnecessary exposure and in-person outpatient visits. Therefore, this study aims to develop a follow-up system for remote monitoring of SSIs in abdominal surgeries. Material and methods This pilot study was carried out in two phases including development and pilot test of the system. First, the main requirements of the system were extracted through a literature review and exploration of the specific needs of abdominal surgery patients in the post-discharge period. Next extracted data was validated according to the agreement level of 30 clinical experts by the Delphi method. After confirming the conceptual model and the primary prototype, the system was designed. In the pilot test phase, the usability of the system was qualitatively and quantitatively evaluated by the participation of patients and clinicians. Results The general architecture of the system consists of a mobile application as a patient portal and a web-based platform for patient remote monitoring and 30-day follow-up by the healthcare provider. Application has a wide range of functionalities including collecting surgery-related documents, and regular assessment of self-reported symptoms via systematic tele-visits based on predetermined indexes and wound images. The risk-based models embedded in the database included a minimum set with 13 rules derived from the incidence, frequency, and severity of SSI-related symptoms. Accordingly, alerts were generated and displayed via notifications and flagged items on clinicians’ dashboards. In the pilot test phase, out of five scheduled tele-visits, 11 (of 13) patients (85%), completed at least two visits. The nurse-centered support was very helpful in the recovery stage. Finally, the result of a pilot usability evaluation showed users’ satisfaction and willingness to use the system. Conclusion Implementing a telemonitoring system is potentially feasible and acceptable. Applying this system as part of routine postoperative care management can provide positive effects and outcomes, especially in the era of coronavirus disease when more willingness to telecare service is considered.

Background: Asymptomatic malaria is a major challenge to be addressed in the implementation of the malaria elimina­tion program. The main goal of the malaria surveillance system in the elimination phase is to identify reliably all the positive cases of malaria reliably (symptomatic and asymptomatic) in the shortest possible time. This study focused on the monitoring of asymptomatic malaria reservoirs in areas where local transmission had been previously established. Methods: It was a case-study approach that was conducted in the Anarestan area. A total of 246 residents and immi­grants living in the area at the age range of 4–60 years old were randomly selected to be tested for malaria by micro­scope, RDT, and nested-PCR techniques. The inclusion criterion for participants to be entered into the study was the absence of specific symptoms of malaria. Moreover, participants who have been taking antimalarials for the last month were excluded from the study. Results: The results indicated no positive cases of asymptomatic malaria among the participants tested by all methods. Conclusion: The results of this study have shown that, without concerns for asymptomatic parasitic patients, a malaria elimination program has been successfully implemented within the studies area. In addition, the findings emphasized the existence of a strong malaria surveillance system in this area.

Objective: To evaluate the effectiveness and safety of ivermectin in patients with mild and moderate COVID-19. Methods: This study was a single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design on 68 patients with COVID-19. According to the 1:1 ratio between the study groups (ivermectin group and standard treatment group), patients were randomly admitted to each intervention arm. Results: The mean age of the participants in the ivermectin group was (48.37±13.32) years. Eighteen of them were males (54.5%) and the participants in the control group had a mean age of (46.28±14.47) years, with nineteen of them being males (59.4%). As a primary outcome, after 5 days of randomization, there was no significant difference between the ivermectin group and the control group in the length of stay in the hospital (P=0.168). ICU admission (P=0.764), length of stay in ICU (P=0.622), in-hospital mortality (P=0.427), adverse drug reactions, and changes in the mean difference of laboratory data had not any significant difference between the two groups (except for urea change). In addition, the radiologic findings of the two groups of patients were not significantly different. Linear regression analysis showed that for every 10 years increase of age, 0.6 day of hospitalization duration was increased. There was no statistically significant association between other variables and clinical outcomes. Conclusions: Among adult hospitalized patients with moderate to severe COVID-19, there was no significant relationship between the administration of ivermectin single dose in a five-day course and clinical improvement, and mortality of the participants.

Introduction: Although a long time past since COVID-19 was broken out, it is hard to determine which pharmacological combination regimen is more efficacious. The present study aimed to evaluate the efficacy of lopinavir/ritonavir (LPV/r) plus interferon (IFN) beta-1a regimen compared to the hydroxychloroquine (HCQ) regimen in moderately ill patients with COVID-19. Methods: A multiple-centre retrospective observational case-controlled study was performed between March and September 2020, including adults with confirmed COVID-19. The patients were categorised into age- and sex-matched two groups; LPV/r plus IFN beta-1a (n = 102) and HCQ (n = 298) regimens. Clinical outcomes and mortality rates were compared between the groups. Results: LPV/r plus interferon (INF) beta-1a regimen had improved none of the clinical outcomes and mortality rate compared to the HCQ regimen. The length of stay (LOS) in the hospital and the need for oxygen therapy were slightly worse in the LPV/r plus INF beta-1a regimen (4.73 ± 2.93 days, 63%) than in the HCQ group (3.74 ± 3.30 days, 48.3%). No statistically significant difference was observed between the two groups in care of intensive care unit (ICU) admission, LOS in ICU, the need for non-invasive ventilation and the need for invasive mechanical ventilation as well as in-hospital mortality rate. Conclusions: LPV/r plus IFN beta-1a regimen did not show any meaningful improvement in clinical outcomes or mortality compared to the HCQ regimen. Larger randomised controlled trials are needed to assess the efficacy of this combination further.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza viruses produce a wide range of clinical disease severity, which varies from asymptomatic infection to death. The outbreak of coronavirus disease 2019 (COVID-19) in Wuhan, Hubei, China, followed a seasonal influenza pandemic. The prevalence of influenza has changed since the outbreak of COVID-19. In this study, we have compared the prevalence of influenza and COVID-19 since the onset of the pandemic. Clinical symptoms were also assessed among patients. Materials and Methods: The present study was conducted in a single center on 229456 patients with the SARS in Hormozgan province, Iran, during 2019-2021 before and after the COVID-19 pandemic. Clinical features including age, sex, fever, cough, shortness of breath, nausea, dizziness, headache, body aches, and diarrhea were also analyzed. Results: The results indicated that out of a total of 229456 samples of patients, 71142 (31.00%) and 527 (.22%) cases were diagnosed with positive COVID-19 and positive influenza, respectively. Influenza activity decreased in March 2020 and remained low until September 2021, but it increased to near pre-pandemic seasonal levels since October 2021. The outbreak of influenza decreased by starting the restrictions and health protocols. Furthermore, the analysis of patients’ symptoms indicated that the most prevalent symptoms in influenza patients were fever, cough, and body pain, while the symptoms in COVID-19 patients were cough and headache. Conclusion: Social restrictions and adherence to health protocols could significantly reduce the incidence of seasonal influenza even after controlling the COVID-19 pandemic. Influenza and COVID-19 have similar symptoms in patients, so diagnostic tests are necessary for proper diagnosis and management.

Background & Aims: There are few studies showing the association between vitamin D deficiency and COVID-19 severity and mortality. This study designed to investigate the relationship between vitamin D deficiency and the severity and mortality of COVID-19. Materials & Methods: The present cross-sectional study was conducted on 48 COVID-19 patients with positive PCR test results. Patients were divided into three groups according to their serum 25-OH vitamin D3 levels: group 1

Background: To promote mitigation strategies and public health response, this study aimed to evaluate the population-based seroprevalence of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in Hormozgan province. Materials and Methods: The study was conducted within 10 districts of Hormozgan province with 1325 participants for three months by considering three-month successive follow-ups to evaluate the durability of humoral immunity. The participants completed the questionnaire, and blood samples were taken followed by immunoassay SARS-CoV-2 ELISA testing. Results: In general, 717 (54.1%) males and 596 (45.9%) females participated in this study. In phase one, 147 (11.1%) and 182 (14.7%) tested positive for immunoglobulin M (IgM) and IgG, respectively. Upon three months, 13.8% and 17.8% tested positive for IgG and at least for one of the antibodies. Based on the results, 606 (45.7%) cases reported no symptoms while 673 (50.8%) of them reflected at least one. Among 798 (60.2%) participants, the most common symptoms were headache (n = 244, 18.4%), sore throat (n = 186, 14.0%), weakness (n = 150, 11.3%), muscular pain (n = 139, 10.5%), and sputum cough (n = 134, 10.1%). The odds of the antibodies in females was 1.37 (95% CI: 1.03, 1.82, P = 0.03). In phase 2, 43 (5.3%) participants persisted positive for IgG while 559 (73%) tested negative for IgG. Finally, 20% of the suffered participants tested positive for IgG until nine months. Conclusion: Although IgG antibodies decreased in the first six months, their titers persisted stable for nine months. It seems our population has not reached a desirable level of protection. It is stressed that mass vaccination is needed to prevent future epidemic waves.

There is some indication that coronavirus disease 2019 (COVID-19) causes hypothalamic-pituitary-adrenal axis insufficiency. However, being on glucocorticoids makes it difficult to fully investigate this axis, especially in patients with severe COVID-19. We aimed to discover if there was a connection between blood total cortisol and adrenocorticotropic hormone (ACTH) levels and mortality in patients with COVID-19. In Iran, 154 hospitalized patients with COVID-19 were studied in a prospective cohort study. ACTH and cortisol levels in the blood were measured on the first or second day of hospitalization. Most patients (52.6 vs. 47.4%) were men over 50 years old (55.8%), and 44.4% had an underlying illness. Serum cortisol and plasma ACTH medians were 15.6 (μg/dl) and 11.4 (pg/ml), respectively. 9.09% of the patients died. Cortisol levels were substantially lower in those who died (11.3 μg/dl) than in patients who were discharged (16.7 μg/dl, P

Abstract Objectives We will evaluate the efficacy and safety of Ivermectin in patients with mild and moderately severe COVID-19. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a 2-arm parallel-group design (1:1 ratio). Participants The Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will screen for patients age ≥ 20 years and weight ≥35 kg for the following criteria: Inclusion criteria for patients with mild COVID-19 symptoms (outpatients) 1. Diagnosed mild pneumonia using computed tomography (CT) and/or chest X-ray (CX-R) imaging, not requiring hospitalization. 2. Signing informed consent. Inclusion criteria for patients with moderate COVID-19 symptoms (inpatients) 1. Confirmed infection using PCR. 2. Diagnosed moderate pneumonia using CT and/or CXR imaging, requiring hospitalization. 3. Hospitalized ≤ 48 hours. 4. Signing informed consent. Exclusion criteria 1. Severe and critical pneumonia due to COVID-19. 2. Underlying diseases, including AIDS, asthma, loiasis, and severe liver and kidney disease. 3. Use of anticoagulants (e.g., warfarin) and ACE inhibitors (e.g., captopril). 4. History of drug allergy to Ivermectin. 5. Pregnancy or breastfeeding. Intervention and comparator Intervention groups: Outpatient and inpatient groups will receive the standard treatment regimen for mild and moderate COVID-19, based on the Iranian Ministry of Health and Medical Education's protocol, along with oral Ivermectin (MSD Company, France) at a single dose of 0.2 mg/kg. Control groups: The outpatient group will receive hydroxychloroquine sulfate (Amin Pharmaceutical Company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for seven subsequent days. The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. Other supportive and routine care will be the same in both outpatient and inpatient groups. Main outcome The primary outcomes are composite and include the improvement of clinical symptoms and need for hospitalization for outpatient groups, and the length of hospital stay until discharge, the need for ICU admission until discharge, and the need for mechanical ventilation for inpatient groups within seven days of randomization. The secondary outcome is the incidence of serious adverse drug reactions within seven days of randomization. Randomization Patients in both outpatient (mild) and inpatient (moderate) groups will be randomized into the treatment and control groups based on the following method. A simple randomization method and table of random numbers will be used. If the selected number is even, the patient is allocated to the treatment group, and if it is odd, the patient is allocated to the control group in a 1:1 ratio. Blinding (masking) This is an open-label study, and there is not blinding. Numbers to be randomized (sample size) A total number of 120 patients (60 outpatients and 60 patients) will be randomized into two groups (30 patients in each of the intervention groups and 30 patients in each of the control groups). Trial Status The protocol is Version 1.0, November 17, 2020. Recruitment began November 25, 2020, and is anticipated to be completed by February 25, 2021. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “ IRCT20200506047323N6 ”. The registration date is November 17, 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 the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

Abstract Objectives To investigates the effectiveness of curcumin-containing Nanomicelles as a therapeutic supplement in the treatment of patients with COVID-19 and its effect on immune responses balance changes following treatment. Trial design This study is conducted as a prospective, placebo-controlled with parallel group, single-center randomized clinical trial on COVID-19 patients. Participants Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran. Inclusion criteria: 1. Real time PCR-approved positive COVID-19 test. 2. Both gender 3. Age between 18 and 75 years 4. Signing a written consent 5. Lack of participation in other clinical trials Exclusion criteria: 1. Pregnancy or lactation 2. Allergy to turmeric or curcumin 3. Smoking 4. Patient connected to the ventilator 5. SaO2 less than 90% or PaO2 less than 8 kPa 6. Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7. History of gallstones 8. History of gastritis or active gastrointestinal ulcer Intervention and comparator In addition to the routine standard treatments for COVID-19, in the intervention group, 40mg nanomicelles containing curcumin (SinaCurcumin Capsule, Exir Nano Sina Company, Iran), four times per day (after breakfast, lunch, dinner and before bedtime) and in the placebo group as the control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran) are prescribed for two weeks. Main outcomes The effectiveness of Nano micelles containing curcumin treatment will be evaluated as daily clinical examinations of patients in both groups and, on days 0, 7 and 14, complete clinical symptoms and laboratory findings including peripheral blood and serum parameters such as inflammatory markers will be measured and recorded. Moreover, in order to evaluate the balance of immune responses changes following treatments, serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines will be measured in both groups at time points of 0, 7 and 14 days post treatment. Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment. Randomisation Randomized trials will be performed on 40 COVID-19 patients which will be randomized using encoded sealed boxes with computer generated random digits with 1:1 allocation ratio. In order to randomization, placebo and SinaCurcumin Capsules will be numbered first by computer generated random digits. SinaCurcumin and placebo will then be stored and numbered in sealed packages based on generated random numbers. Finally, according to the order in which patients enter the study, packages are given to patients based on their number. Blinding (masking) The present study will be blind for all patients, physicians and nurses, laboratory technicians and statisticians. Numbers to be randomised (sample size) A total of 40 patients will be included in the study, 20 of them will be randomly assigned to the intervention group and 20 to the placebo group. Trial status This is Version 1.0 of protocol dated 21 May 2020. The recruitment was started June 24, 2020 and is expected to be completed by October 31, 2020. Trial registration This present clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code of “IRCT20200611047735N1”, https://www.irct.ir/trial/48843 . Dated: 19 June 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.

Abstract Objectives We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria: 1. Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. 2. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. 3. Hospitalized ≤ 48 h. 4. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. Exclusion criteria: 1. Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. 2. Severe and critical COVID-19 pneumonia. 3. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. 4. Pregnancy and breastfeeding. Intervention and comparator Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day. Control group: lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups. Main outcomes The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization. Randomization Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group). Trial status The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3 . Registered on 22 July 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 the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

No abstract

Abstract Objectives We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. Participants Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. Main outcomes The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. Randomization An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. Blinding (masking) All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. Numbers to be randomized (sample size) A total of 84 participants will be randomized into two groups of 42 patients. Trial Status The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “ IRCT20200506047323N1 ”. Registration date is 23 May 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.