Difference In Clinical Status Research Articles

Early Outpatient Administration of Remdesivir Shortens Recovery Time in Patients with Mild to Moderate COVID-19

Background: During COVID-19, healthcare systems in underdeveloped nations had significant challenges and were unlikely to offer the necessary care. It appears that a new, reliable healthcare model that prevents hospitalization is necessary to reduce the pressure that COVID-19 is putting on healthcare systems and patients. More particularly, as Remdesivir's use as an outpatient treatment for mild to severe SARS-CoV-2 infection has rarely been examined; we aimed to investigate in-depth comprehension of the effects of Remdesivir in these cases. Methods: In our two-month cross-sectional study, non-hospitalized patients with mild to moderate COVID-19 who were referred to the hospital for up to 5 days of Remdesivir treatment received 200 mg of Remdesivir intravenously on day 1, followed by 100 mg of Remdesivir once daily for the subsequent 4 days. Patients were divided into groups based on the time of starting Remdesivir treatment after the appearance of symptoms: group 1 less than and equal to 7 days, and group 2 more than 7 days. Two groups were evaluated for a correlation between Remdesivir administration time and clinical symptoms on days 1 and 14 (follow-up visits). Results: The study enrolled 273 eligible patients with a mean age of 47.5 years, of whom 112 were males and 125 were females. Results showed that patients who received Remdesivir in the first 7 days had less dyspnea (P-value<0.0001) and lung involvement (P-value<0.0001) than those who received it after 7 days at the end of the study. Patients who came later to receive Remdesivir also showed higher fatigue, AST, and ALT levels on the first day. Conclusions: Among patients with moderate COVID-19, those who received a 5-day course of Remdesivir within 7 days of the onset of symptoms had a statistically significant difference in clinical status compared with those who received their treatments later. However, the size of this finding has uncertain clinical importance.

The effectiveness of Tocilizumab in severe covid 19 pneumonia among critically ill patients

Background: Tocilizumab, an interleukin-6 (IL-6) antagonist, is being evaluated for the management of covid-19 pneumonia. The objective of this study was to assess the effectiveness of Tocilizumab in severe covid-19 pneumonia. Methods: This was a retrospective, observational, single centre study performed in 121 patients diagnosed with severe covid-19 pneumonia. 83 patients received standard of care treatment whereas 38 patients received tocilizumab along with standard of care. Tocilizumab was administered intravenously at 8mg/kg (upto a maximum of 800mg). The second dose of Tocilizumab was given 12 to 24 hours apart. The primary outcome measure was ICU related and hospital related mortality. The secondary outcome measures were change in clinical status of patients measured by WHO (World Health Organisation) 7 category ordinary scale, changes in interleukin-6 (IL-6) levels, secondary infections and duration of ICU stay. Results: Tocilizumab was administered between 3-27 days after the patient reported symptoms ( a median of 10.9 days ) and between the 1st to 3rd day of ICU admission (median of 2.1 days) . In Tocilizumab group, 16(42.1%) of 38 patients died in ICU whereas in standard of care group, 27(32.53%) of 83 patients died. The difference in clinical status assessed using WHO (World Health Organisation) 7 category ordinary scale at 28 days between Tocilizumab group and standard of care group was not statistically significant (odds ratio 1.35, 95% confidence interval 0.61 to 2.97, p = 0.44). Conclusion: Tocilizumab plus standard care was not superior to standard care alone in reducing mortality and improving clinical outcomes at day 28.

Comparison of Efficacy of Remdesivir with Supportive Care Alone in the Treatment of Critically Sick Adult and Child COVID-19 Patients: A Randomized Clinical Trial

Background: Seeking new specific and effective drugs against Coronavirus Diseases-2019 (COVID-19) is of great importance. This study describes the efficacy of remdesivir with supportive care alone in the treatment of critically sick adult and child COVID-19 patients. Method: This study was a one-blind placebo-controlled, randomized clinical trial in adults (aged≥18 years) and children (aged≤12 years) in Iran. Patients were included if they had positive PCR test for SARS-CoV-2 infection, O2 saturation ≤88%, and compatible symptoms. All participants received standard care following national treatment guidelines. The treatment group received remdesivir (200 mg IV on day 1 and followed by 100 mg in single daily infusions). The control group received standard care and an identical volume of placebo infusions (Water for injection) for 5 days. For pediatric patients, the intervention group received remdesivir (5mg/kg on the first day and then 5.2 mg/kg on days 2 to 5). Discharge from the hospital within 10 days of first treatment is considered as the primary endpoint of the study. Admission in the intensive care unit (ICU) is considered as original secondary endpoint of the study. Results: 141 patients were enrolled and randomly assigned to two group (adults; 54 patients in the intervention group vs. 52 patients in the control group, and children; 17 patients in the intervention group vs. 18 patients in the control group). The mean time from the first symptoms until the referral to the hospital in adult patients was 5.61 ± 2.67 day and 4.80±1.48 day for intervention and control groups, respectively. The mean time from the first symptoms until death was reported to be significant and was longer for intervention group than the control group (24.83 ± 11.25 vs. 10.50 ± 2.42 day; p value=0. 012). For children who received remdesivir, the mean time between admission until death was reported to be significant, as the finding highlighted a longer time duration for the intervention group (13.55 ± 0.72 vs. 10.66 ± 0.57 day; p value=0. Mechanicalanical ventilation was used in 17 patients (100%) and 18 patients (100%) in the intervention and control groups, respectively (p value=0.853). Conclusion: Among patients with critical COVID-19, those randomized to a 5-day treatment of remdesivir did have a statistically significant difference in clinical status compared with the control group of both adults and children. Clinical Trial Registration Number: This study is registered in the Iranian Registry of Clinical Trial (No. IRCT 20200405046953N1).

Managing bifurcations: are two stents better than one?

Abstract Introduction Bifurcation percutaneous coronary intervention (PCI) is associated with a higher degree of complexity when compared with non-bifurcation procedures. Although 1-stent PCI remains the standard approach for most bifurcation lesions, data is constantly being published on 2-stent PCI. Aim To evaluate and compare the characteristics and outcomes of patients that underwent bifurcation PCI with one or two stents. Methods Single center, retrospective observational study including all patients who underwent bifurcation PCI between January 2015-December 2018. We defined two groups: 1-stent PCI group (1s-PCI) and 2-stent PCI group (2s-PCI). The 2s-PCI group included PCI patients with all the different techniques used in our center: provisional stenting with 2 stents, Cullote, crushing stent and DK Crush. Results 1s-PCI group included 376 individuals and 2s-PCI group included 26. Overall baseline clinical characteristics were balanced between groups. There was no statistically significant difference in age (mean 64 vs 66; p=0.388), gender (79% vs 85% males; p=0.622) and comorbidities (hypertension, diabetes mellitus, hypercholesterolemia, chronic kidney disease, smoking and previous history of coronary artery disease). Also, there was no difference in clinical status (NSTEMI 36% vs 38%; stable disease 32% vs 42%; STEMI 28% vs 19%; unstable angina 5% vs 0%; p=0.419). Coronary angiography and lesion distribution were similar in both groups (p=0.367). However, radiation dose (median 90.5 [IQR=79] vs 156 [IQR=84] mGy cm2; p<0,001) and contrast volume (median 150 [IQR=100] vs 156 [IQR=83] ml; p<0,001) were significantly higher in 2s-PCI group. At 12-month follow-up, mortality rate was higher in 1s-PCI group, but without statistical significance (8% vs 4%; p=0.71); the same is true for acute myocardial infarction at 12 months (3% vs 0%; p=0.368). Target-lesion failure was only reported in 4 patients in the 1s-PCI group. Survival tests showed no significant difference between groups (χ2(1,n=402)=0.634; p=0.426). Conclusion Individuals that underwent 1s-PCI were overall similar to those who underwent 2s-PCI. Predictably, deploying more than 1 stent required more contrast volume and implied a higher radiation dose. We should note that our studied is greatly limited by the 2s-PCI group size, which may justify the lack of difference in the evaluated outcomes. Funding Acknowledgement Type of funding sources: None.

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19

Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown. To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment. Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020. Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d. The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group. Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care. Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance. ClinicalTrials.gov Identifier: NCT04292730.

Prescription Audit of Anti-fungal Treatment of Dermatophytoses in the Dermatology Out Patient Department of a Tertiary Care Hospital

Aims: To study the prescriptions of clinically diagnosed cases of dermatophytoses, to evaluate medical treatment of clinical failure cases, any rise in serum ALT (Alanine aminotransferase) levels associated with usage of oral anti-fungal drugs, availability of drugs in the hospital pharmacy and cost minimization of different oral treatment regimens with Griseofulvin, Fluconazole, Itraconazole and Terbinafine. Settings and design: Dermatology Out Patient Department (OPD) of a tertiary care hospital, single centre prospective cohort observational study. Materials and Methods: 370 patients from the Dermatology Out Patient Department (OPD) diagnosed of dermatophytoses were enrolled. Follow-up was done 3±1 weeks apart, twice for newly diagnosed patients and once for patients on ongoing therapy. Two separate blood samples were collected 3±1 weeks apart for estimation of serum ALT. The prime lesion in each patient was graded as mild, moderate and severe. Patients were categorized as clinically cured, clinically improved, or as clinical failure following treatment. Statistical analysis used: Descriptive statistics, Fischer’s exact test and Wilcoxon’s signed rank test. Results: Azoles were the most commonly prescribed antifungals. Clinical status of patients was independent of the oral antifungal drug received (p > 0.05). A statistically significant difference in clinical status between compliant and non-compliant patients was seen (p < 0.05). A statistically significant increase in serum ALT levels was seen (p < 0.05) however, it was not clinically significant. 55.52% of drugs were unavailable in the hospital formulary. The average expenses per prescription was approximately INR 1123.55. Itraconazole was the most expensive treatment regimen followed by terbinafine and fluconazole. Conclusions: There exists a non-uniformity in the management of dermatophytoses due to lack of adequate guidance and nonavailability of drugs and clinical cure of patients depends upon compliance to therapy.

Usefulness of Red Cell Width Distribution (RDW) in the Assessment of Children with Pulmonary Arterial Hypertension (PAH)

Red cell width distribution (RDW) is known to be a prognostic marker in adults with pulmonary hypertension. The value of this test in the pulmonary arterial hypertension (PAH) pediatric population was not yet established. The aim of the study was to evaluate the prognostic value of RDW in children with PAH and utility of this parameter in the management. Data were collected retrospectively in 61 patients with PAH confirmed by right heart catheterization. RDW was measured at diagnosis, 3 and 12 months after initial therapy, during and after deterioration if occurred. Results were compared with NTproBNP, WHO-FC and oxygen blood saturation. Mean RDW at baseline was 15.3 ± 2.4% (12.1–24.4, median 14.7%) and was elevated in 29 patients (47%). There were no significant difference in clinical status, NTproBNP and hemodynamic parameters among patient with normal and elevated RDW at diagnosis. Poor negative correlation with SaO2 and SvO2 was shown. After 3 and 12 months of treatment no significant change of RDW level was found despite of statistically significant improvement of WHO-FC and decrease of NTproBNP level (NS). Episodes of clinical deterioration weren’t connected with change of RDW level (16 vs. 15.6% NS). Kaplan–Meier analysis did not show differences in prognosis between patients with normal and elevated RDW. Elevation of RDW was not associated with any measured parameters. Prognostic value of RDW in the pediatric PAH population was not confirmed. Usefulness of RDW in management in PAH pediatric population is limited and required further studies.

Gender, Estrogen, and Schizophrenia

Most of the evidence to support an association between estrogen and psychosis is indirect and comes from clinical studies of gender differences in schizophrenia and from studies of fluctuating levels of psychopathology in different phases of the menstrual cycle. Our data, as well as those of other investigators, suggest a significantly later age at onset of schizophrenia in women than in men. There is somewhat more direct evidence from animal studies indicating that estrogen modulates dopamine systems in a manner similar to neuroleptics, although there are some inconsistencies in the literature. Few studies have examined the effects of estrogen administration in conjunction with neuroleptics on psychotic symptoms. We present a case report of a postmenopausal woman with schizophrenia who had an improvement in positive symptoms with estrogen replacement therapy. Long-term double-blind treatment studies are needed to investigate the effects of estrogen on psychotic symptoms in women with schizophrenia.

Effect of eicosapentaenoic acid in asthma.

The role of arachidonic acid metabolites in the pathogenesis of airway inflammation and clinical asthma is currently unknown. The addition of eicosapentaenoic acid (EPA) to the diet of humans has been shown to generate metabolites that are less potent than their arachidonic acid counterparts. The substitution of EPA for arachidonic acid metabolites in patients might cause a decrease in airway inflammation and an improvement in clinical asthma. We studied the effect of addition of EPA to the diet of twelve asthmatic patients. Standard clinical evaluations and pulmonary function tests were done on weeks 0, 3, 6, 10, 12 and 14. Patients ingested either low-dose EPA (0.1 g/day) or high-dose EPA (4.0 g/day) from weeks 6-14 (total of 8 weeks). There was no difference in clinical status or pulmonary function between groups at the start of the study. There was no change in clinical status or pulmonary function between or within groups at the end of 8 weeks of EPA ingestion.