Inhaled and intranasal ciclesonide for the treatment of covid-19 in adult outpatients: CONTAIN phase II randomised controlled trial

Abstract Objective To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. Design Randomised, double blind, placebo controlled trial. Setting Three Canadian provinces (Quebec, Ontario, and British Columbia). Participants 203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea. Intervention Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days. Main outcome measures The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex. Results The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval −7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered. Conclusion Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed. Trial registration ClinicalTrials.gov NCT04435795 .

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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The effectiveness of Kinesio Taping® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520916859 ◽

2020 ◽

Vol 34 (7) ◽

pp. 877-889 ◽

Cited By ~ 1

Author(s):

Venta Donec ◽

Raimondas Kubilius

Keyword(s):

Knee Osteoarthritis ◽

Controlled Trial ◽

Intervention Group ◽

Outpatient Rehabilitation ◽

Control Group ◽

Double Blind ◽

Kinesio Taping ◽

Patient Reported ◽

Double Blinded

Objective: To evaluate the effectiveness of the Kinesio Taping® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). Design: Randomized, double-blinded, controlled trial. Setting: Outpatient rehabilitation department. Subjects: A total of 187 subjects with symptomatic I–III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n = 81 (123 knees); control group, n = 76 (114 knees). Intervention: The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. Main measures: Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants’ experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p < 0.05. Results: The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was –2.2 ± 3.2 seconds, at follow-up –2.4 ± 3.1 seconds; in control group –2.8 ± 3.6 seconds, and –2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ2 = 7.5, df = 2, p = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p < 0.005). Conclusion: Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.

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Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial

The Journals of Gerontology Series A ◽

10.1093/gerona/glaa254 ◽

2020 ◽

Author(s):

Phoebe Ullrich ◽

Christian Werner ◽

Martin Bongartz ◽

Tobias Eckert ◽

Bastian Abel ◽

...

Keyword(s):

Cognitive Impairment ◽

Older Persons ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Life Space ◽

Home Based ◽

Independent Life

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.

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OP0159 EFFICACY OF COMPREHENSIVE TECHNOLOGY-ASSISTED HOME-BASED EXERCISE IN ANKYLOSING SPONDYLITIS: A RANDOMIZED, CONTROLLED TRIAL

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5100 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 100.3-100

Author(s):

Y. Wang ◽

X. Liu ◽

Y. Shi ◽

X. Ji ◽

W. Wang ◽

...

Keyword(s):

Exercise Intervention ◽

Medical Center ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Group Differences ◽

Control Group ◽

Home Based ◽

The Mean

Background:Clinical practice guidelines recommend that exercise is an essential component in the self-management of Ankylosing Spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be burdensome and patients may decline participation, whereas, effective home-based exercise interventions that do not need regular medical center visits are likely to be more accessible and acceptable for patients with AS. Recently, increasing evidences have been accumulated that the wearable devices could facilitate patients with inflammatory arthritis by giving exercise instructions and improving self-efficacy. Therefore, patients with AS may benefit from an effective technology-assisted home-based exercise intervention.Objectives:To investigate the efficacy of a comprehensive technology-assisted home-based exercise intervention on disease activity in patients with AS.Methods:This study was a 16-week assessor-blinded, randomized, waiting-list controlled trial (ChiCTR1900024244). Patients with AS were randomly allocated to the home-based exercise intervention group and the waiting-list control group. A 16-week comprehensive exercise program consisting of a moderate intensity (64%-76% HRmax) aerobic training for 30min on 5 days/week and a functional training for 60min on 3 days/week was given to patients in the intervention group immediately after randomization, with 1.5h training sessions for two consecutive days by a study physical therapist at baseline and Week 8. The aerobic exercise intensity was controlled by a Mio FUSE Wristband with a smartphone application. The functional training consisted of the posture training, range of motion exercises, strength training, stability training and stretching exercises. Patients in control group received standard care during the 16-week follow-up and started to receive the exercise program at Week 16. The primary outcome was ASDAS at Week 16. The secondary outcomes were BASDAI, BASFI, BASMI, ASAS HI, peak oxygen uptake, body composition and muscle endurance tests. The mean difference between groups in change from baseline was analyzed with the analysis of covariance.Results:A total of 54 patients with AS were enrolled (26 in intervention group and 28 in control group) and 46 (85.2%) patients completed the 16-week follow-up. The mean difference of ASDAS between groups in change from baseline to 16-week follow-up was −0.2 (95% CI, −0.4 to 0.003, P = 0.032), and the mean change from baseline was -0.4 (95% CI, -0.5 to -0.2) in the intervention group vs -0.1 (95% CI, -0.3 to 0.01) in the control group, respectively. Significant between-group differences were found between groups for BASDAI (−0.5 [95% CI, −0.9 to −0.2], P = 0.004), BASMI (−0.7 [95% CI, −1.1 to −0.4], P <0.001), BASFI (−0.3 [95% CI, −0.6 to 0.01], P=0.035), peak oxygen uptake (2.7 [95% CI, 0.02 to 5.3] ml/kg/min, P=0.048) and extensor endurance test (17.8 [95% CI, 0.5 to 35.2]s, P=0.044) at Week 16. Between-group differences were detected in ASAS HI (−0.9 [95% CI, −1.7 to −0.1], P=0.030), body fat percentage (−1.0 [95% CI, −2.0 to −0.01] %, P=0.048) and visceral adipose tissue (−4.9 [95% CI, −8.5 to −1.4] cm2, P=0.008) at Week 8, but not at Week 16. No significant between-group differences were detected in the total lean mass, time up and go test and the flexor endurance test during the follow-up.Conclusion:Comprehensive technology-assisted home-based exercise has been shown to have beneficial effects on disease activity, physical function, spinal mobility, aerobic capacity, and body composition as well as in improving fatigue and morning stiffness of patients with AS.References:[1]van der Heijde D, Ramiro S, Landewé R, et al. Ann Rheum Dis 2017;76:978–991.Disclosure of Interests:None declared

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Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073689 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3689

Author(s):

Tzofnat Zadok-Gurman ◽

Ronit Jakobovich ◽

Eti Dvash ◽

Keren Zafrani ◽

Benjamin Rolnik ◽

...

Keyword(s):

Stress Reduction ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Stressful Events ◽

Control Group ◽

Subjective Well Being ◽

Intention To Treat ◽

School Year ◽

Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

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Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

Health Informatics Journal ◽

10.1177/1460458221996409 ◽

2021 ◽

Vol 27 (1) ◽

pp. 146045822199640

Author(s):

Faranak Kazemi Majd ◽

Vahideh Zarea Gavgani ◽

Ali Golmohammadi ◽

Ali Jafari-Khounigh

Keyword(s):

Randomized Controlled Trial ◽

Hospital Readmission ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

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Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receiving Bad News: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2013.51.2756 ◽

2014 ◽

Vol 32 (20) ◽

pp. 2166-2172 ◽

Cited By ~ 91

Author(s):

Maiko Fujimori ◽

Yuki Shirai ◽

Mariko Asai ◽

Kaoru Kubota ◽

Noriyuki Katsumata ◽

...

Keyword(s):

Communication Skills ◽

Patient Preferences ◽

Controlled Trial ◽

Intervention Group ◽

Depression Scale ◽

Skills Training ◽

Control Group ◽

Communication Skills Training ◽

Communication Performance

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽

10.1161/circ.125.suppl_10.ap186 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jaime Céspedes ◽

German Briceño ◽

Michael Farkouh ◽

Rajesh Vedanthan ◽

Martha Leal ◽

...

Keyword(s):

Educational Intervention ◽

Cardiovascular Health ◽

Controlled Trial ◽

Intervention Group ◽

Educational Programs ◽

Control Group ◽

Active Lifestyle ◽

And Control ◽

The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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