scholarly journals Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19

2020 ◽  
Vol 7 (7) ◽  
Author(s):  
Jun Chen ◽  
Lu Xia ◽  
Li Liu ◽  
Qingnian Xu ◽  
Yun Ling ◽  
...  
Keyword(s):  
Antiviral Activity ◽  
Interferon Alpha ◽  
Clearance Rate ◽  
Standard Of Care ◽  
Study Groups ◽  
Control Group ◽  
Open Label ◽  
Intention To Treat ◽  
Interferon Alpha 2B ◽  
And Control

Abstract Background We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients. Methods In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)–confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274). Results From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2–5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups (P = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable (P = 1.0). The frequencies of adverse events in the 2 groups were comparable. Conclusions Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.

scholarly journals Early treatment with inhaled GM-CSF improves oxygenation and anti-viral immunity in COVID-19 induced lung injury – a randomized clinical trial

2021 ◽  
Author(s):  
Bart Lambrecht ◽  
Karel Van Damme ◽  
Elisabeth De Leeuw ◽  
Jozefien Declercq ◽  
Bastiaan Maes ◽  
...  
Keyword(s):  
Group Treatment ◽  
Standard Of Care ◽  
Care Group ◽  
Control Group ◽  
Viral Immunity ◽  
Open Label ◽  
Hypoxemic Respiratory Failure ◽  
Gm Csf ◽  
Macrophage Colony ◽  
And Control

Abstract Granulocyte-macrophage colony-stimulating factor (GM-CSF) instructs monocytes to differentiate into alveolar macrophages (AM) that preserve lung homeostasis. By comparing AM development in mouse and human, we discovered that COVID-19 patients showed marked defects in GM-CSF-dependent AM instruction. The multi-center, open-label, randomized, controlled SARPAC-trial evaluated the efficacy and safety of 5 days of inhalation of rhu-GM-CSF (sargramostim, Leukine®) in 81 non-ventilated patients with COVID-19 and hypoxemic respiratory failure identified by PaO2/FiO2 ratio < 350mmHg. At day 6, more patients in the sargramostim group experienced at least 25% improvement in oxygenation compared with the standard of care group. Higher numbers of circulating class-switched B cells and effector virus-specific CD8 lymphocytes were found in the sargramostim group. Treatment adverse events, including signs of cytokine storm, were not different between active and control group. This proof-of-concept study demonstrates the feasibility and safety of inhaled GM-CSF in restoring alveolar gas exchange, while simultaneously boosting anti-COVID-19 immunity. ClinicalTrials.gov (NCT04326920).

scholarly journals GLUCOCOVID: A controlled trial of methylprednisolone in adults hospitalized with COVID-19 pneumonia

2020 ◽  
Author(s):  
Luis Corral-Gudino ◽  
Alberto Bahamonde ◽  
Francisco Arnaiz-Revillas ◽  
Julia Gómez-Barquero ◽  
Jesica Abadía-Otero ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Composite Endpoint ◽  
Standard Of Care ◽  
Control Group ◽  
Open Label ◽  
Protein Levels ◽  
Intention To Treat ◽  
Reactive Protein ◽  
Short Course ◽  
Stratified Analysis

ABSTRACTBackgroundWe aimed to determine whether a 6-day course of intravenous methylprednisolone (MP) improves outcome in patients with SARS CoV-2 infection at risk of developing Acute Respiratory Distress Syndrome (ARDS).MethodsMulticentric, partially randomized, preference, open-label trial, including adults with COVID-19 pneumonia, impaired gas exchange and biochemical evidence of hyper-inflammation. Patients were assigned to standard of care (SOC), or SOC plus intravenous MP [40mg/12h 3 days, then 20mg/12h 3 days]. The primary endpoint was a composite of death, admission to the intensive care unit (ICU) or requirement of non-invasive ventilation (NIV).ResultsWe analyzed 85 patients (34, randomized to MP; 22, assigned to MP by clinician’s preference; 29, control group). Patients’ age (mean 68±12 yr) was related to outcome. The use of MP was associated with a reduced risk of the composite endpoint in the intention-to-treat, age-stratified analysis (combined risk ratio -RR-0.55 [95% CI 0.33-0.91]; p=0.024). In the per-protocol analysis, RR was 0.11 (0.01-0.83) in patients aged 72 yr or less, 0.61 (0.32-1.17) in those over 72 yr, and 0.37 (0.19-0.74, p=0.0037) in the whole group after age-adjustment by stratification. The decrease in C-reactive protein levels was more pronounced in the MP group (p=0.0003). Hyperglycemia was more frequent in the MP group.ConclusionsA short course of MP had a beneficial effect on the clinical outcome of severe COVID-19 pneumonia, decreasing the risk of the composite end point of admission to ICU, NIV or death.

scholarly journals A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19)

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0242763 ◽  
Author(s):  
Cheng-Pin Chen ◽  
Yi-Chun Lin ◽  
Tsung-Chia Chen ◽  
Ting-Yu Tseng ◽  
Hon-Lai Wong ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Public Hospitals ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Viral Shedding ◽  
Randomized Controlled ◽  
And Control

Objective In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study. Methods Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020. Results There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70). Conclusions Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.

School-based obesity interventions in the metropolitan area of Rio De Janeiro, Brazil: pooled analysis from five randomised studies

2021 ◽  
pp. 1-7
Author(s):  
Renata da R. M. Rodrigues ◽  
Bruna K. Hassan ◽  
Michele R. Sgambato ◽  
Bárbara da S. N. Souza ◽  
Diana B. Cunha ◽  
...  
Keyword(s):  
Eating Habits ◽  
Intervention Group ◽  
Pooled Analysis ◽  
Control Group ◽  
Intention To Treat ◽  
School Year ◽  
School Based ◽  
Obesity Interventions ◽  
The One ◽  
And Control

Abstract School-based studies, despite the large number of studies conducted, have reported inconclusive results on obesity prevention. The sample size is a major constraint in such studies by requiring large samples. This pooled analysis overcomes this problem by analysing 5926 students (mean age 11·5 years) from five randomised school-based interventions. These studies focused on encouraging students to change their drinking and eating habits, and physical activities over the one school year, with monthly 1-h sessions in the classroom; culinary class aimed at developing cooking skills to increase healthy eating and attempts to family engagement. Pooled intention-to-treat analysis using linear mixed models accounted for school clusters. Control and intervention groups were balanced at baseline. The overall result was a non-significant change in BMI after one school year of positive changes in behaviours associated with obesity. Estimated mean BMI changed from 19·02 to 19·22 kg/m2 in the control group and from 19·08 to 19·32 kg/m2 in the intervention group (P value of change over time = 0·09). Subgroup analyses among those overweight or with obesity at baseline also did not show differences between intervention and control groups. The percentage of fat measured by bioimpedance indicated a small reduction in the control compared with intervention (P = 0·05). This large pooled analysis showed no effect on obesity measures, although promising results were observed about modifying behaviours associated with obesity.

Altered plasma and erythrocyte phospholipid fatty acid profile in elite female water polo and football players

2012 ◽  
Vol 37 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Aleksandra Arsić ◽  
Vesna Vučić ◽  
Jasna Tepšić ◽  
Sanja Mazić ◽  
Marina Djelić ◽  
...  
Keyword(s):  
Oleic Acid ◽  
Stearic Acid ◽  
Palmitoleic Acid ◽  
Phospholipid Fatty Acid ◽  
Study Groups ◽  
Control Group ◽  
Football Players ◽  
Water Polo ◽  
And Control ◽  
The Impact

The impact of chronic, intense exercise, such as in elite athletes, on phospholipids fatty acids (FA) composition has not been studied in women so far. This study aimed to investigate FA profiles in plasma and erythrocytes phospholipids in elite female water polo (N = 15) and football (N = 19) players in comparison with sedentary women. In spite of similar dietary patterns, as assessed by a food frequency questionnaire, plasma FA profile in the football players showed significantly higher proportions of stearic acid, oleic acid, and monounsaturated FA (MUFA), and significantly lower proportions of total and n-6 polyunsaturated FA (PUFA) than in the water polo and control group. The water polo players had higher percentages of palmitoleic acid and arachidonic acid than the control subjects. Erythrocyte FA profile differed among groups. We found significantly higher proportion of oleic acid and MUFA in the football group than in the controls, and decreased stearic acid and elevated palmitic and palmitoleic acid in the water polo players than in the other 2 groups. Both groups of athletes had significantly lower percentages of n-6 dihomo-γ-linolenic acid, n-6 PUFA, and total PUFA compared with the controls. The estimated activities of elongase and desaturases in erythrocytes were also altered in the athletes. Our results indicate that long-term, intense physical training significantly affects FA status of plasma and erythrocyte phospholipids in women. The observed differences between the water polo and the football players suggest that the type of regular training may contribute to the altered metabolism of FA, although possible genetic differences among the 3 study groups cannot be ruled out.

scholarly journals Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

2011 ◽  
Vol 32 (9) ◽  
pp. 872-880 ◽  
Author(s):  
Stephanie A. Fritz ◽  
Bernard C. Camins ◽  
Kimberly A. Eisenstein ◽  
Joseph M. Fritz ◽  
Emma K. Epplin ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Soft Tissue ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Intention To Treat ◽  
Intranasal Mupirocin ◽  
Mupirocin Ointment ◽  
Hygiene Education ◽  
To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

2021 ◽  
pp. 004947552098474
Author(s):  
Arjuman Sharmin ◽  
Ali Hossain ◽  
Nazmul Islam ◽  
Zakir H Sarker ◽  
Sheikh S Hossain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lymph Node ◽  
Complete Resolution ◽  
Conventional Treatment ◽  
Symptomatic Improvement ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Lymph Node Tuberculosis ◽  
And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals A randomised, open label comparative study of hydroxychloroquine with betamethasone oral mini pulse in the management of patients with alopecia areata

2021 ◽  
Vol 10 (2) ◽  
pp. 187
Author(s):  
Jeyasudha Jambusayee ◽  
Kulur Mukhyaprana Sudha
Keyword(s):  
Alopecia Areata ◽  
Life Quality ◽  
Autoimmune Disorder ◽  
Study Groups ◽  
Pulse Therapy ◽  
The Body ◽  
Control Group ◽  
Study Group ◽  
Open Label ◽  
Significant Difference

Background: Alopecia areata is an autoimmune disorder causing patchy hair loss on scalp and other parts of the body and leading to poor self-esteem and anxiety in patients. Treatment with topical or systemic drugs like steroids or other immunosuppressants is associated with adverse effects. Hydroxychloroquine is an antimalarial drug, with T cell modulating function. This study was undertaken to assess the safety, efficacy and tolerability of Hydroxychloroquine in Alopecia areata compared to betamethasone oral mini pulse (OMP) therapy. Methods: 60 patients with alopecia areata were randomized into two groups of 30 each. Control group received tab. betamethasone 5 mg/day on two consecutive days of week for 12 weeks and Study group received tab. hydroxychloroquine 200 mg/day for 12 weeks. They were followed-up for further 12 weeks. Scale of alopecia tool, dermatology life quality index and global assessment at baseline, 12 weeks and 24 weeks were used to assess the outcome.Results: 94 patients were screened and 60 patients were included. All patients completed the study. At the end of 12 weeks, there was a statistically significant reduction in SALT and DLQI scores in both control and study groups. But at the end of 24 weeks, the study group showed an increase in the scores. Relapses were more in the study group. No significant difference in the incidence of adverse events was noted between the two groups.Conclusions: Hydroxychloroquine 200 mg/day is less efficacious in the management of alopecia areata in comparison to betamethasone oral mini pulse therapy.

scholarly journals Complexity of EEG Signals in Schizophrenia Syndromes

2019 ◽  
Author(s):  
Илья Кутепов ◽  
Ilya Kutepov ◽  
Вадим Крысько ◽  
Vadim Krysko ◽  
Антон Крысько ◽  
...  
Keyword(s):  
Study Groups ◽  
Classification Problem ◽  
Multiscale Entropy ◽  
Control Group ◽  
Eeg Signals ◽  
Additional Tool ◽  
Chaotic Signals ◽  
And Control ◽  
Further Development ◽  
Electroencephalogram Eeg

In the present study, 45 patients with schizophrenia syndromes and 39 healthy subjects are studied with electroencephalogram (EEG) signals. The study groups were of different genders. For each of the two groups, the signals were analyzed using 16 EEG channels. Multiscale entropy, Lempel-Ziv complexity and Lyapunov exponent were used to study the chaotic signals. The data were compared for two groups of subjects. Entropy was compared for each of the 16 channels for all subjects. As a result, topographic images of brain areas were obtained, illustrating the entropy and complexity of Lempel-Ziv. Lempel-Ziv complexity was found to be more representative of the classification problem. The results will be useful for further development of EEG signal classification algorithms for machine learning. This study shows that EEG signals can be an effective tool for classifying participants with symptoms of schizophrenia and control group. It is suggested that this analysis may be an additional tool to help psychiatrists diagnose patients with schizophrenia.

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