Efficacy of a multiple-indication antiviral herbal drug (Saliravira®) for COVID-19 outpatients: A pre-clinical and randomized clinical trial study.

BACKGROUND: The scientific researches on COVID-19 pandemic topics are headed to an explosion of scientific literature. Despite these global efforts, the efficient treatment of patients is an in-progress challenge. Based on a meta-study of published shreds of evidence about compounds and their botanic sources in the last six decades, a novel multiple-indication herbal compound (Saliravira®) has been developed. Based on the antiviral, anti-inflammatory, and immune-enhancing properties of its ingredients, we hypothesized that Saliravira® has the potential to act as an antiviral agent, accelerate treatment, and reduce undesirable effects of COVID-19. METHODS: In this randomized, controlled, open-label clinical trial, COVID-19 outpatients were included by RT-PCR test or diagnosis of physicians according to the symptoms. Participants were randomly divided into intervention and control groups to receive Saliravira® package plus routine treatments of COVID-19 or routine treatments of COVID-19 alone, respectively. Saliravira® package includes tablets, nasal-sinuses spray, oral-pharynx spray, and inhaler drops. The treatment was for 10 days and followed up till 23 days after admission. RESULTS: On the 8th day, the "mean reduction rates" of viral load of the patients in the intervention group was 50% lower compared to the control group with a p-value < 0.05. The improvement of 10 out of 14 COVID-19 symptoms in the intervention group was significantly accelerated. The mean treatment duration of patients in the intervention group was 4.9 days less than the control group. In addition, no patients in the intervention group were hospitalized compared to 28% of the control group needed to be hospitalized.

Comparing efficacy and safety of different doses of dexamethasone in the treatment of COVID-19: a three-arm randomized clinical trial.

BACKGROUND AND OBJECTIVES: Corticosteroids are commonly used in the treatment of hospitalized patients with COVID-19. The goals of the present study were to compare the efficacy and safety of different doses of dexamethasone in the treatment of patients with a diagnosis of moderate to severe COVID-19. METHODS: Hospitalized patients with a diagnosis of moderate to severe COVID-19 were assigned to intravenous low-dose (8 mg once daily), intermediate-dose (8 mg twice daily) or high-dose (8 mg thrice daily) dexamethasone for up to 10 days or until hospital discharge. Clinical response, 60-day survival and adverse effects were the main outcomes of the study. RESULTS: In the competing risk survival analysis, patients in the low-dose group had a higher clinical response than the high-dose group when considering death as a competing risk (HR = 2.03, 95% CI: 1.23-3.33, p = 0.03). Also, the survival was significantly longer in the low-dose group than the high-dose group (HR = 0.36, 95% CI = 0.15-0.83, p = 0.02). Leukocytosis and hyperglycemia were the most common side effects of dexamethasone. Although the incidence was not significantly different between the groups, some adverse effects were numerically higher in the intermediate-dose and high-dose groups than in the low-dose group. CONCLUSIONS: Higher doses of dexamethasone not only failed to improve efficacy but also resulted in an increase in the number of adverse events and worsen survival in hospitalized patients with moderate to severe COVID-19 compared to the low-dose dexamethasone. (IRCT20100228003449N31).

Interpretation of Hematological, Biochemical, and Immunological Findings of COVID-19 Disease: Biomarkers Associated with Severity and Mortality.

The severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) spread rapidly all over the world in late 2019 and caused critical illness and death in some infected patients. This study aimed at examining several laboratory factors, especially inflammatory and immunological mediators, to identify severity and mortality associated biomarkers. Ninety-three hospitalized patients with confirmed coronavirus disease 2019 (COVID-19) were classified based on disease severity. The levels of biochemical, hematological, immunological, and inflammatory mediators were assessed, and their association with severity and mortality were evaluated. Hospitalized patients were mostly men (77.4%) with an average (standard deviation) age of 59.14 (14.81) years. The mortality rate was significantly higher in critical patients (85.7%). Increased serum levels of blood sugar, urea, creatinine, uric acid, phosphorus, total bilirubin, serum glutamic-oxaloacetic transaminase, serum glutamic-oxaloacetic transaminase, lactic dehydrogenase, C-reactive protein, ferritin, and procalcitonin were significantly prevalent (p=0.002, p<0.001, p<0.001, p=0.014, p=0.047, p=0.003, p<0.001, p<0.001, p<0.001, p<0.001, P<0.001, and p<0.001, respectively) in COVID-19 patients. Decreased red blood cell, hemoglobin, and hematocrit were significantly prevalent among COVID-19 patients than healthy control subjects (p<0.001 for all). Troponin-I, interleukin-6, neutrophil/lymphocyte ratio (NLR), procalcitonin, and D-dimer showed a significant association with the mortality of patients with specificity and sensitivity more than 60%. Age, sex, underlying diseases, blood oxygen pressure, complete blood count along with C-reactive protein, lactic dehydrogenase, procalcitonin, D-dimer, and interleukin-6 evaluation help to predict the severity and required management for COVID-19 patients. Further investigations are highly recommended in a larger cohort study for validation of the present findings.

Severe diabetic ketoacidosis and coronavirus disease 2019 (COVID-19) infection in a teenage patient with newly diagnosed diabetes.

Objectives Recently, World Health Organization has declared coronavirus disease 2019 (COVID-19) infection a pandemic. Patients with diabetes may be at an increased risk of developing COVID-19 infection, as well as increased risk of morbidity and mortality. Although the current data have shown that the coronavirus infection generally has a milder course in children. Case presentation In this case report, we present a teenage patient with severe diabetic ketoacidosis (DKA) as the first manifestation of his diabetes and COVID-19 infection. Conclusions He was treated for DKA and COVID-19 infection, and fortunately, had a good response to the treatment.

Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.

BACKGROUND: There is no study regarding the use of SOF/LDP in treatment of COVID-19.  Objectives: In this study, the efficacy and safety of SOF/LDP were assessed in treatment of patients with mild to moderate COVID-19. METHODS: Among an open-label randomized clinical trial, 82 patients with mild to moderated COVID-19 were assigned to receive either SOF/LDP 400/100 mg daily plus the standard of care (SOF/LDP group, n=42) or the standard of care alone (control group, n=40) for 10 days. Time to clinical response, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were assessed. RESULTS: Clinical response occurred in 91.46% of patients. Although rates of clinical response were comparable between the groups but it occurred faster in the SOF/LDP group than the control group (2 vs. 4 days respectively, P= 0.02). Supportive cares were provided in the medical wards for most patients but 17.07% of patients were transferred to ICU during the hospitalization course. However, durations of hospital and ICU stay were comparable between the groups.  14--day mortality rate was 7.14% and 7.5% in the SOF/ LDP and control groups respectively. No adverse effects leading to drug discontinuation occurred. Gastrointestinal events (nausea, vomiting and diarrhea) were the most common side effects (15.85%). CONCLUSION: Added to the standard of care, SOF/LDP accelerated time to the clinical response. However, rate of clinical response, duration of hospital and ICU stay and 14-day mortality were not different. No significant adverse event was detected.  More randomized clinical trials with larger sample sizes are needed to confirm the efficacy and safety of SOF/LDP in the treatment of COVID-19.

Development of the First Guideline for Professional Conduct in Medical Practice in Iran.

INTRODUCTION: Professional behavior is first learned at the university. One of the necessary considerations in maintaining the professional environment of the university is establishing a set of codes for the behavior of physicians and medical students. This paper describes the process of developing the professional code of conduct in Tehran University of Medical Sciences, Tehran, Iran. METHODS: A review of Iranian and international literature was performed to develop the first draft of the guideline. In sessions of group discussion by the authors, the articles of the draft were evaluated for relevancy, clarity, and lack of repetition. The draft was sent for evaluation to all participants, including the medical faculty members, residents, and medical students, four times and necessary corrections were made according to the comments received. RESULTS: The final guideline included 76 behavior codes in 6 categories, including altruism, honor and integrity, responsibility, respect, justice, and excellence. The codes of the guideline cover the physicians' commitments in the physician-patient, physician-colleague, and instructor-student relationships in order to improve the quality of the services. CONCLUSION: The Islamic and Iranian culture were taken into consideration in developing the guideline. Accordance with the administrative and educational conditions of the universities was ensured in developing the guideline and its acceptance was ensured through extensive surveys. Thus, it is expected that this guideline will be very effective in enhancing professional commitment in medical universities.

Clinical Characteristic of the HIV/AIDS Patients with Cryptosporidiosis Referring to Behavioral Diseases Consultation Center, Imam Khomeini Hospital, Tehran in 2013.

BACKGROUND: Cryptosporidium is known as an opportunist disease-causing agent in man in recent decades. It causes diarrhea and intestinal disorders in the immune deficit and immune competent individuals. This study was aimed to investigate the clinical characteristics of HIV/AIDS patients with cryptosporidiosis infection. METHODS: This cross-sectional descriptive study was performed on 53 HIV/AIDS patients referred to the Behavior Disease Consultation Center of Imam Khomeini Hospital in Tehran, Iran in 2013. First, the patients were studied clinically and the context data were recorded in a questionnaire for parasitological examination and referred to the laboratory for eosinophil count, and CD4 count per ml of blood. RESULTS: Cryptosporidiosis was observed in 4 (7.6%) of the total 53 HIV/AIDS patients. The highest prevalence of infection was observed in the age range of 30-39 yr. It was observed in different sexes as 5.7% of male and 1.9% of female, but statistically was insignificant (P=0.163).75% of patients had no intestinal symptom, 11.4% with acute diarrhea and 3.8% with chronic diarrhea. Cryptosporidiosis cases were observed in 5.7% of patients without intestinal symptom. CONCLUSION: Practitioners in the clinical examination for the detection of the opportunistic intestinal protozoan infection should use clinical and paraclinical characteristics of the HIV/AIDS patients for the diagnostic of Cryptosporidium and other opportunistic parasitic diseases.

Therapeutic effects of minocycline on mild-to-moderate depression in HIV patients: a double-blind, placebo-controlled, randomized trial.

Patients with the HIV infection are at high risk for developing depression. The aim of this study was to investigate the safety and efficacy of antidepressant effects of minocycline on HIV patients with depression. Forty-six HIV patients, with mild-to-moderate depression and a Hamilton Depression Rating Scale (HDRS) up to 18, participated in a parallel, randomized, double-blind, placebo-controlled trial and underwent 6 weeks of treatment with either minocycline (100 mg twice daily) or placebo in the same manner. Patients were assessed using HDRS at baseline and at weeks 3 and 6. The primary outcome measure was to evaluate the efficacy of minocycline in improving depressive symptoms. General linear model repeated measures showed significant effect for time × treatment interaction on the HDRS score during the trial course [F(2, 88)=7.50, P=0.001]. There was no significant difference between the two groups regarding adverse events. No serious adverse event was reported. The administration of 100 mg minocycline twice daily seems to be safe and effective in improving depressive symptoms in HIV/AIDS patients with mild-to-moderate depression.