SARS-CoV-2 organising pneumonia: ‘Has there been a widespread failure to identify and treat this prevalent condition in COVID-19?’

Reviews of COVID-19 CT imaging along with postmortem lung biopsies and autopsies indicate that the majority of patients with COVID-19 pulmonary involvement have secondary organising pneumonia (OP) or its histological variant, acute fibrinous and organising pneumonia, both well-known complications of viral infections. Further, many publications on COVID-19 have debated the puzzling clinical characteristics of ‘silent hypoxemia’, ‘happy hypoxemics’ and ‘atypical ARDS’, all features consistent with OP. The recent announcement that RECOVERY, a randomised controlled trial comparing dexamethasone to placebo in COVID-19, was terminated early due to excess deaths in the control group further suggests patients present with OP given that corticosteroid therapy is the first-line treatment. Although RECOVERY along with other cohort studies report positive effects with corticosteroids on morbidity and mortality of COVID-19, treatment approaches could be made more effective given that secondary OP often requires prolonged duration and/or careful and monitored tapering of corticosteroid dose, with ‘pulse’ doses needed for the well-described fulminant subtype. Increasing recognition of this diagnosis will thus lead to more appropriate and effective treatment strategies in COVID-19, which may lead to a further reduction of need for ventilatory support and improved survival.

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Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽

10.1136/bmjopen-2020-043699 ◽

2021 ◽

Vol 11 (1) ◽

pp. e043699

Author(s):

Morten Riemenschneider ◽

Lars G Hvid ◽

Steffen Ringgaard ◽

Mikkel K E Nygaard ◽

Simon F Eskildsen ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomised Controlled Trial ◽

Usual Care ◽

Treatment Strategy ◽

Controlled Trial ◽

Treatment Strategies ◽

Control Group ◽

Disease Course ◽

Disability Progression ◽

Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

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Mindfulness-based and cognitive-based stress prevention in student teachers (startklar): study protocol of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-021941 ◽

2019 ◽

Vol 9 (2) ◽

pp. e021941

Author(s):

Jasmina Eskic ◽

Sophie Merle Kuhlmann ◽

Katharina Kreinbihl ◽

Florian Hammerle

Keyword(s):

Randomised Controlled Trial ◽

Student Teachers ◽

Study Protocol ◽

Controlled Trial ◽

Control Group ◽

High Risk Population ◽

Stress Prevention ◽

Positive Effects ◽

Randomised Controlled

IntroductionTeachers and student teachers in Germany are a high-risk population for stress and stress-related mental health problems. This often leads to early retirement in subsequent professional life. Various trials have demonstrated positive effects of stress prevention training on the perceived stress and stress-related symptoms of teachers. Although many studies show positive effects of mindfulness-based stress interventions, there is not yet any mindfulness-based intervention for teachers or student teachers in Germany. The aim of this trial is to evaluate a training that combines mindfulness-based and cognitive interventions into one programme, addressing to the specific burdens of student teachers.Methods and analysisThis study protocol presents a prospective block-randomised controlled trial. Assessment will take place at three time points (baseline, post-intervention, 3-month follow-up) for an intervention and waiting control group, and at a fourth assessment point for the waiting control group after receiving the training. The aim is to evaluate the effects of mindfulness-based stress prevention on stress, psychological morbidity, burnout and self-efficacy using validated measures. Participants are student teachers from German teacher training colleges and participation will be voluntary. The targeted total sample size is 96 at 3-month follow-up. The training will comprise three 4-hour sessions conducted every 2 weeks. The control group will participate in the training after the 3-month follow-up. The allotment will be randomised with a stratified allocation ratio by gender. After descriptive statistics have been evaluated, inferential statistical analysis will be conducted using repeated measures analysis of variance with interactions between time and group. Effect sizes will be calculated using partial η2values.Ethics and disseminationResults will be disseminated at conferences, in specialist magazines and through peer-reviewed publications. The trial has been approved by the ethics review board of the local medical association, Mainz, Germany, under the reference number 837.192.16 (10511).Trial registration numberDRKS00010897.

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Role of Interferon Therapy in Severe COVID-19: The COVIFERON Randomized Controlled Trial

10.21203/rs.3.rs-136499/v1 ◽

2021 ◽

Author(s):

Ilad Alavi Darazam ◽

Mohamad Amin Pourhoseingholi ◽

Shervin Shokouhi ◽

Seyed Sina Naghibi Irvani ◽

Majid Mokhtari ◽

...

Keyword(s):

Viral Infections ◽

Controlled Trial ◽

Ordinal Scale ◽

Control Group ◽

P Value ◽

Open Label ◽

Subcutaneous Injections ◽

Positive Effects ◽

Significant Difference ◽

Registration Number

Abstract Type 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI=1.10-5.17, P-value=0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI=0•63-3•16, P-value=0•395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies. Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768)

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The effect of dried plum on serum levels of receptor activator of NF-κB ligand, osteoprotegerin and sclerostin in osteopenic postmenopausal women: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114514000671 ◽

2014 ◽

Vol 112 (1) ◽

pp. 55-60 ◽

Cited By ~ 19

Author(s):

Shirin Hooshmand ◽

Jayme R. Y. Brisco ◽

Bahram H. Arjmandi

Keyword(s):

Postmenopausal Women ◽

Controlled Trial ◽

Statistical Significance ◽

Serum Levels ◽

Whole Body ◽

Control Group ◽

Protective Properties ◽

Positive Effects ◽

Receptor Activator ◽

Randomised Controlled

Although several studies have confirmed the bone-protective properties of dried plum, its exact mechanisms of action remain unclear. Recent research has shown that osteocytes may control bone formation via the production of sclerostin and bone resorption via the receptor activator of NF-κB ligand (RANKL) and its inhibitor osteoprotegerin (OPG). To investigate the mechanism of action of dried plum in reversing bone loss, we measured serum levels of RANKL, OPG and sclerostin in osteopenic postmenopausal women (n 160). Participants were randomly assigned to the treatment group of either 100 g dried plum/d or 75 g dried apple/d (comparative control) for 1 year. All participants received 500 mg Ca plus 400 IU (10 μg) vitamin D daily. Bone mineral densities (BMD) of the lumbar spine, forearm, hip and whole body were assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline and after 12 months to assess bone biomarkers. Dried plum significantly increased the BMD of the ulna and spine in comparison with the control group. In comparison with corresponding baseline values, dried plum increased the RANKL levels by only +1·99 v. +18·33 % and increased the OPG levels by +4·87 v. − 2·15 % in the control group. Serum sclerostin levels were reduced by − 1·12 % in the dried plum group v. +3·78 % in the control group. Although percentage changes did not reach statistical significance (P≤ 0·05), these preliminary data may indicate that the positive effects of dried plum on bone are in part due to the suppression of RANKL production, the promotion of OPG and the inhibition of sclerostin.

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Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)

BMJ Open ◽

10.1136/bmjopen-2020-037515 ◽

2020 ◽

Vol 10 (9) ◽

pp. e037515

Author(s):

Matilda Cederberg ◽

Lilas Ali ◽

Inger Ekman ◽

Kristina Glise ◽

Ingibjörg H Jonsdottir ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Mental Disorders ◽

Sick Leave ◽

Self Efficacy ◽

Standard Care ◽

Common Mental Disorders ◽

Controlled Trial ◽

Control Group ◽

Positive Effects ◽

Randomised Controlled

IntroductionThe number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.Methods and analysisThis study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.Ethics and disseminationThis study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.Trial registration numberNCT03404583.

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Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial

Scientific Reports ◽

10.1038/s41598-021-86859-y ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Ilad Alavi Darazam ◽

Shervin Shokouhi ◽

Mohamad Amin Pourhoseingholi ◽

Seyed Sina Naghibi Irvani ◽

Majid Mokhtari ◽

...

Keyword(s):

Viral Infections ◽

Controlled Trial ◽

Ordinal Scale ◽

Control Group ◽

P Value ◽

Open Label ◽

Subcutaneous Injections ◽

Positive Effects ◽

Significant Difference ◽

Registration Number

AbstractType 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400 mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10–5.17, P-value = 0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63–3.16, P-value = 0.395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies.Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768).

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Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i07/02 ◽

2018 ◽

Vol 3 (07) ◽

Author(s):

Ms. Sonam Yangchen Bhutia ◽

Dr. Sushma Kumari Saini ◽

Dr. Manmeet Kaur ◽

Dr. Sandhya Ghai

Keyword(s):

School Children ◽

Home Visit ◽

Controlled Trial ◽

Family Members ◽

Sampling Technique ◽

Control Group ◽

Food Hygiene ◽

Parent Communication ◽

Post Test ◽

Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members. After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

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