scholarly journals Pre-Exposure Prophylaxis with Various Doses of Hdroxychloroquine among high-risk COVID 19 Healthcare Personnel: CHEER randomized controlled trial

Author(s):  
Fibhaa Syed ◽  
Mohammad Ali Arif ◽  
Rauf Niazi ◽  
Jaffer Bin Baqar ◽  
Ume Laila Hashmi ◽  
...  

Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break the chain of transmission of novel coronavirus (2019-nCoV). Aims: This trial aimed to evaluate the safety and efficacy of PrEP with various doses of HCQ against a placebo among high-risk healthcare providers (HCPs). Methods: A phase II, randomized, placebo-controlled trial was conducted at a tertiary care hospital. A total of 228 HCPs were screened, we included 200 subjects with no active or past SARS-CoV-2 infection. Subjects of experimental groups 1-3 received HCQ in various doses and those in the control group received placebo. The study outcomes in terms of safety and efficacy were monitored. Participants exhibiting COVID-19 symptoms were tested for SARS-CoV-2 during the study and also by the end of the 12th week, with PCR or IgM and IgG serology. Results: Overall, 146 of 200 participants reported exposure to a confirmed COVID-19 case in the first month, 189 in the 2nd month and 192 were exposed by the 12th week of the study. Moreover, the precautionary practices, i.e. use of personal protective equipment (PPE), significantly varied; initially more than 80% of the exposed HCPs weren't ensuring the PPE used by the patients treated by them. However, it gradually developed with the increasing knowledge of the virus. As far as safety is concerned, mild treatment-related side effects were observed among the interventional and placebo arm patients. While none of the participants were critical, and a few had mild illness by the end of the 12th week, requiring only outpatient observation with no hospitalization. There was no significant clinical benefit of PrEP with HCQ as compared to placebo (p>0.05). Conclusion: It is concluded from the study findings that the PrEP HCQ does not significantly prevent illness compatible with COVID-19 or confirmed infection among high-risk HCPs.

2020 ◽  
pp. 026921552095633
Author(s):  
Anabela Correia ◽  
Carla Pimenta ◽  
Marta Alves ◽  
Daniel Virella

Objective: To assess the effect of a domiciliary program of oculomotor and gaze stability exercises on the incidence of falls and risk of fall in stroke survivors. Design: Two-arm, non-blinded parallel randomized controlled trial. Subjects: Stroke survivors older than 60 years, with positive Romberg test and autonomous gait after the stroke. Setting: Physiotherapy outpatient clinic of a tertiary care hospital. Interventions: Every participant accomplished the current rehabilitation program; the intervention group was randomly allocated into an additional three weeks intervention with a domiciliary program of oculomotor and gaze stability exercises. Main measures: Primary outcome was the incidence of falls through the three weeks after the intervention started; in addition, the variation of the estimated risk for falling assessed by both Berg Balance Scale (four points) and Timed Up and Go Test (four seconds) was the secondary outcome. Results: 79 patients were recruited and 68 completed the protocol (control group 35; intervention group 33). During the follow up, falls were registered in 4/35 participants in the control group and no event occurred in the intervention group ( P = 0.064). The estimated risk for falling decreased in 11/35 control group participants and in 28/33 intervention group participants (RR 0.37; 95%CI 0.22–0.62; P < 0.001). Conclusion: After three weeks of a domiciliary program of oculomotor and gaze stability exercises, the estimated risk of falling significantly diminished and no falls occurred among the intervention group. These findings encourage further exploration of this promising intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT02280980.


2020 ◽  
Vol 41 (S1) ◽  
pp. s411-s411
Author(s):  
Priscila Gonçalves ◽  
Fernando Gatti de Menezes ◽  
Ana Carolina Santiago ◽  
Laura Kataoka ◽  
Paula Fernanda Martineli ◽  
...  

Background: Improving adherence to hand hygiene (HH) of healthcare workers (HCWs) is a challenge for health institutions, and the use of technologies has been considered an important strategy within this process. Methods: To evaluate the impact of the use of alcohol-based hand rub gel (ABHR) dispensers with light sensors on the adherence to HH by HCWs. This is a prospective quasi-experimental study with comparative analysis between two 4-bed adult intensive care units at a private, tertiary-care hospital conducted over 22 weeks. An approach detection module with an LED lamp was attached to the ABHR dispenser. As a healthcare personnel approached it, the sensor was activated, and a red light turned on as a visual stimulus for HH. The color of the light changed to blue when HH was performed. All ABHR dispensers had electronic counters, but light sensors were installed only in the 4-bed dispensers of the intervention unit. Throughout the period, direct observation of adherence to HH was performed by 4 nurses who had previously been rated with an excellent coefficient of agreement (κ test = 0.951 and 0.902). At the end of the study, a perception survey was performed with the HCWs. Results: The median activation of ABHR dispensers per week was higher in the intervention unit with 1,004 (IQR, 706–1,455) versus 432 (IQR, 350–587) in the control group (P < .001). The same occurred when compared to the median activation per 1,000 patient days, with 53,069 (IQR, 47,575–67,275) versus 19,602 (IQR, 15,909–24,500) in the control group (P < .001). However, there was no evidence of difference in adherence to HH during direct observation between the 2 groups: 51.0% HH compliance (359 of 704) in the control group and 53.8% HH compliance (292 of 543) in the intervention group (P = .330). The same result emerged when we evaluated the “My Five Moments for HH” and by professional category. HCWs (N=66) answered the perception survey: 66.6% stated that lighting devices caught their attention regularly or most of the time and 59% agreed that the devices motivated HH. Conclusions: Using light sensors in ABHR dispensers can be an effective technology for improving HH. This finding was evident in the evaluation of the number of uses of the ABHR dispensers and in the HCW perceptions. Although direct observation did not show statistical evidence of difference between the groups, adherence was higher in the intervention group.Funding: NoneDisclosures: None


Author(s):  
Sujana Thalamati ◽  
Sailaja Bandaru ◽  
Divyasree Bhumireddy

Background: Pre-eclampsia (PE) is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. The objective of the present study was to assess and compare the safety and efficacy of oral nifedipine and intravenous labetalol in the management of severe pre-eclampsia.Methods: A double-blind, randomized, controlled trial was conducted at a tertiary care hospital in Andhra Pradesh, on pregnant women presenting with a systolic blood pressure of 160 mm Hg or more or diastolic blood pressure of 110 mm Hg or more. The pregnant women were randomized to receive Oral nifedipine (10 mg tablet orally up to five doses) and intravenous labetalol injection in escalating doses until the target blood pressure of 150 mm Hg systolic and 100 mm Hg diastolic, or lower, was achieved. The primary endpoint of the study was the time taken by each agent to achieve target blood pressure. Secondary endpoints were number of doses required, adverse maternal and neonatal effects, side effect profile, and perinatal outcome.Results: The study was conducted in a tertiary care hospital in Andhra Pradesh from July 2016 to October 2017, on 100 pregnant women presenting with preeclampsia. The median time taken to achieve target blood pressure was 44 minutes (range: 20-60 minutes) for Oral Nifedipine and 68 minutes (range: 40-85 minutes) for Intravenous labetalol (P=0.008).  No serious adverse maternal or perinatal side effects were encountered in both the groups.Conclusions: Both oral nifedipine and intravenous labetalol are effective in the management of acute hypertensive emergencies of pregnancy; however, oral nifedipine effectively decreased the blood pressure rapidly compared to intravenous labetalol.


2021 ◽  
Vol 8 (3) ◽  
pp. 212-219
Author(s):  
Amit Kumar ◽  
P. Sindhusha ◽  
P.J.N. Satyavathi ◽  
N. Pragnasai ◽  
P. Deepika ◽  
...  

A high-risk pregnancy is any condition associated with a pregnancy where there is an actual or potential risk to the mother or fetus. Risk assessment is a key component of antenatal care (ANC) and has demonstrated benefits in improving maternal and perinatal outcomes. To assess maternal complications that occurs in antenatal women and their neonatal outcomes in a tertiary care hospital.200 antenatal women, admitted to obstetrics & gynaecology department from 16-09-2020 to 15-03-2021 were evaluated. Antenatal women with maternal complications (Gestational hypertension, preeclampsia, Gestational diabetes, Hypothyroid, Anaemia, Asthma and oligohydramnios) were taken into study group and women with no complications were taken into control group. The risk factors were assessed and risk scores were determined by Dutta and Das scoring system and Hobel risk scoring system. It was found that there was a significant association between poor neonatal outcome and high-risk pregnancies. The incidence of preterm births is higher in the study group (34.1%) when compared with the control group (13.7%). Mode of delivery was predominantly by caesarean section in the study group (p&#60;0.005). Neonatal complications were significantly more (p&#60;0.05) in study group and fetal distress was exclusively seen in the study group (p&#60;0.0005). Maternal complications such as eclampsia correlated significantly with the risk score (p=0.005). Neonatal outcomes such as Low birth weight (p&#60;0.0001) were higher in the high-risk category when compared to the low risk and moderate risk category. There was a significant correlation between high-risk antenatal and poor neonatal outcome. Scoring systems, such as the one used in our study, can be adopted at primary and rural health centres even by a non-medical counsellor as a screening tool to predict pregnancies at high risk for poor neonatal outcome, thereby facilitating early referral of these women to tertiary care centres.


2018 ◽  
Vol 37 (2) ◽  
pp. 184-190
Author(s):  
Preeti Parashar ◽  
Asir John Samuel ◽  
Vencita Priyanka Aranha

Introduction: About 15 million babies are born preterm annually, with every year almost 1 million dying from complications and survivors prone to lifetime disability. Yakson touch and kinaesthetic stimulation techniques have proven effective in minimizing the complications and disability of preterm delivery, but presently there is no standardized protocol for their application. The aim is to investigate the efficacy of Yakson touch in combination with kinaesthetic stimulation (YAKIN) on the motor and behavioural development of neonates at high risk of development delay in comparison to conventional handling.Material and Methods: Neonates will be recruited via parental consent from a recognized tertiary care teaching hospital for this two-group pretest-posttest design of randomized controlled trial (RCT), with allocation into either a control group (n=14) or experimental group (n=14) by block randomization method. The experimental group will receive Yakson touch and kinaesthetic stimulation, whilst the control group will receive conventional handling inclusive of developmental positioning and Kangaroo mother care. The duration of intervention will be five out of seven days. Neonatal behavioural assessment scale (NBAS) will be performed at baseline and then on the 7th day to ascertain the intervention effectiveness.Results: Data analysis will be done by Wilcoxon signed rank test/paired t-test and Mann Whitney U test/independent t-test will be done to compare the pre and post intervention score of NBAS within and between groups. The level of significance will be set as p<0.05.Conclusion: The present study may provide valuable information about early intervention to the neonatal physiotherapist, intensivist, nursing staff and parents of neonates.


Author(s):  
Raja Bhattacharya ◽  
Sampurna Chowdhury ◽  
Anita Nandi ◽  
Rishav Mukherjee ◽  
Manish Kulshrestha ◽  
...  

Background: While several trials are ongoing for treatment of Corona virus 2019 (COVID-19), scientific research on chemoprophylaxis is still lacking even though it has potential to flatten the curve allowing us time to complete research on vaccines.Methods: This retrospective cohort study explores the potential of hydroxychloroquine (HCQ) as a pre- exposure prophylaxis for COVID-19 among 106 health care workers (HCW) exposed to COVID-19 patients, at a tertiary care hospital in India where there was an abrupt cluster outbreak within on duty personnel. HCWs who had voluntarily taken HCQ prior to exposure were considered one cohort while those who had not were considered to be the Control group. All participants with a verifiable high-risk contact history were tested for COVID-19 by RT- PCR.Results: The two cohorts were comparable in terms of age, gender, co-morbidity and exposure. The primary outcome was incidence rates of RT-PCR positive COVID-19 infection among HCQ users and Controls.106 HCW were examined of whom 54 were HCQ users. The comparative analysis of incidence of infection between the two groups demonstrated that voluntary HCQ usage was associated with lesser likelihood of developing severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (4 out of 54 HCW), compared to those who were not on it (20 out of 52 HCW), χ2=14.59, p<0.001. None of the HCQ users noted any serious adverse effects.Conclusions: The study demonstrated that voluntary pre- exposure HCQ prophylaxis by HCWs is associated with a statistically significant reduction in risk of SARS-CoV-2.  


Infection ◽  
2021 ◽  
Author(s):  
Johanna Koehler ◽  
Barbara Ritzer ◽  
Simon Weidlich ◽  
Friedemann Gebhardt ◽  
Chlodwig Kirchhoff ◽  
...  

AbstractAdditional treatment options for coronavirus disease (COVID-19) are urgently needed, particularly for populations at high risk of severe disease. This cross-sectional, retrospective study characterized the outcomes of 43 patients with nosocomial severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection with and without treatment using monoclonal SARS-CoV-2 spike antibodies (bamlanivimab or casirivimab/imdevimab). Our results indicate that treatment with monoclonal antibodies results in a significant decrease in disease progression and mortality when used for asymptomatic patients with early SARS-CoV-2 infection.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ya-ping Xu ◽  
Pei-yu Zhao ◽  
Yi-tong Bai ◽  
Shuang Li

Abstract Background The coronavirus disease (COVID-19) pandemic has had a massive impact on individuals globally. The Chinese government has formulated effective response measures, and medical personnel have been actively responding to challenges associated with the epidemic prevention and control strategies. This study aimed to evaluate the effect of the implementation of a care transition pathway on patients that underwent joint replacement during the COVID-19 pandemic. Methods A quasi-experimental study was designed to evaluate the effect of implementing a care transition pathway for patients who underwent joint replacement during the COVID-19 pandemic in the orthopedic department of a tertiary care hospital in Beijing, China. Using a convenient sampling method, a total of 96 patients were selected. Of these, 51 patients who had undergone joint replacement in 2019 and received treatment via the routine nursing path were included in the control group. The remaining 45 patients who underwent joint replacement during the COVID-19 epidemic in 2020 and received therapy via the care transition pathway due to the implementation of epidemic prevention and control measures were included in the observation group. The quality of care transition was assessed by the Care Transition Measure (CTM), and patients were followed up 1 week after discharge. Results The observation group was determined to have better general self-care preparation, written planning materials, doctor-patient communication, health monitoring, and quality of care transition than the control group. Conclusions A care transition pathway was developed to provide patients with care while transitioning through periods of treatment. It improved the patient perceptions of nursing quality. The COVID-19 pandemic is a huge challenge for health professionals, but we have the ability to improve features of workflows to provide the best possible patient care.


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