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1.
Trials ; 24(1): 185, 2023 Mar 13.
Article in English | MEDLINE | ID: covidwho-2263588

ABSTRACT

BACKGROUND: Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to SARS-CoV-2 infection by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. METHODS: PROTECT-V is a platform trial testing pre-exposure prophylactic interventions against SARS-CoV-2 infection in vulnerable patient populations (organ transplant recipients; individuals with oncological/haematological diagnoses, immune deficiency or autoimmune diseases requiring immunosuppression or on dialysis). Multiple agents can be evaluated across multiple vulnerable populations sharing placebo groups, with the option of adding additional treatments at later time points as these become available. The primary endpoint is symptomatic SARS-CoV-2 infection, and each agent will be independently evaluated in real time when the required number of events occurs. Presently, three agents are approved in the platform: intranasal niclosamide, nasal and inhaled ciclesonide and intravenous sotrovimab. DISCUSSION: Despite the introduction of vaccination, there remains a need for pre-exposure prophylactic agents against SARS-CoV-2. Several patient groups are more vulnerable to COVID-19 disease by virtue of underlying health conditions, treatments received or suboptimal responses to vaccination. TRIAL REGISTRATION: ClinicalTrials.gov NCT04870333. EudraCT 2020-004144-28.


Subject(s)
COVID-19 , Humans , SARS-CoV-2
2.
Acta Anaesthesiol Scand ; 2022 Oct 31.
Article in English | MEDLINE | ID: covidwho-2230506

ABSTRACT

BACKGROUND: Corticosteroids improve outcomes in patients with severe COVID-19. In the COVID STEROID 2 randomised clinical trial, we found high probabilities of benefit with dexamethasone 12 versus 6 mg daily. While no statistically significant heterogeneity in treatment effects (HTE) was found in the conventional, dichotomous subgroup analyses, these analyses have limitations, and HTE could still exist. METHODS: We assessed whether HTE was present for days alive without life support and mortality at Day 90 in the trial according to baseline age, weight, number of comorbidities, category of respiratory failure (type of respiratory support system and oxygen requirements) and predicted risk of mortality using an internal prediction model. We used flexible models for continuous variables and logistic regressions for categorical variables without dichotomisation of the baseline variables of interest. HTE was assessed both visually and with p and S values from likelihood ratio tests. RESULTS: There was no strong evidence for substantial HTE on either outcome according to any of the baseline variables assessed with all p values >.37 (and all S values <1.43) in the planned analyses and no convincingly strong visual indications of HTE. CONCLUSIONS: We found no strong evidence for HTE with 12 versus 6 mg dexamethasone daily on days alive without life support or mortality at Day 90 in patients with COVID-19 and severe hypoxaemia, although these results cannot rule out HTE either.

3.
Trials ; 23(1): 1014, 2022 Dec 14.
Article in English | MEDLINE | ID: covidwho-2162410

ABSTRACT

BACKGROUND: SARS-CoV-2 infection is associated with a significant risk of hospitalisation, death, and prolonged impact on quality of life. Evaluation of new treatment options and optimising therapeutic management of people hospitalised with SARS-CoV-2 infection remains essential, but rapid changes in pandemic conditions and potential therapies have limited the utility of traditional approaches to randomised controlled trials. METHODS: ASCOT ADAPT is an international, investigator-initiated, adaptive platform, randomised controlled trial of therapeutics for non-critically ill patients hospitalised with COVID-19. The study design is open label and pragmatic. Potential participants are hospitalised adults with PCR confirmed, symptomatic, SARS-CoV-2 infection, within 14 days of symptom onset. Domains include antiviral, antibody and anticoagulant interventions, with a composite primary outcome of 28-day mortality or progression to intensive-care level respiratory or haemodynamic support. Initial interventions include intravenous nafamostat and variable dose anticoagulation. A range of secondary endpoints, and substudies for specific domains and interventions are outlined. DISCUSSION: This paper presents the trial protocol and management structure, including international governance, remote site monitoring and biobanking activities and provides commentary on ethical and pragmatic considerations in establishing the ASCOT ADAPT trial under pandemic conditions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12620000445976) and ClinicalTrials.gov (NCT04483960).


Subject(s)
COVID-19 , Adult , Humans , SARS-CoV-2 , Quality of Life , Biological Specimen Banks , Australia , Treatment Outcome
4.
McQuilten, Zoe, Venkatesh, Balasubramanian, Jha, Vivekanand, Roberts, Jason, Morpeth, Susan, Totterdell, James, McPhee, Grace, Abraham, John, Bam, Niraj, Bandara, Methma, Bangi, Ashpak, Barina, Lauren, Basnet, Bhupendra, Bhally, Hasan, Bhusal, Khemr, Bogati, Umesh, Bowen, Asha, Burke, Andrew, Christopher, Devasahayam, Chunilal, Sanjeev, Cochrane, Belinda, Curnow, Jennifer, Dara Reddy, Varaprasad Babu, Das, Santa, Dhungana, Ashesh, Di Tanna, Gian Luca, Dotel, Ravindra, Dsouza, Hyjel, Dummer, Jack, Dutta, Sourabh, Foo, Hong, Gilbey, Timothy, Giles, Michelle, Goli, Kasiram, Gordon, Adrienne, Gyanwali, Pradip, Hudson, Bernard, Jani, Manoj, Jevaji, Purnima, Jhawar, Sachin, Jindal, Aikaj, John, M. Joseph, John, Mary, John, Flavita, John, Oommen, Jones, Mark, Joshi, Rajesh, Kamath, Prashanthi, Kang, Gagandeep, Karki, Achyut, Karmalkar, Abhishek, Kaur, Baldeep, Koganti, Kalyan Chakravarthy, Koshy, Jency, Mathew, S. K.; Lau, Jilllian, Lewin, Sharon, Lim, Lyn-li, Marschner, Ian, Marsh, Julie, Maze, Michael, McGree, James, McMahon, James, Medcalf, Robert, Merriman, Eileen, Misal, Amol, Mora, Jocelyn, Mudaliar, Vijaybabu, Nguyen, Vi, O'Sullivan, Matthew, Pant, Suman, Pant, Pankaj, Paterson, David, Price, David, Rees, Megan, Robinson, James Owen, Rogers, Benjamin, Samuel, Sandhya, Sasadeusz, Joe, Sharma, Deepak, Sharma, Prabhat, Shrestha, Roshan, Shrestha, Sailesh, Shrestha, Prajowl, Shukla, Urvi, Shum, Omar, Sommerville, Christine, Spelman, Tim, Sullivan, Richard, Thatavarthi, Umashankar, Tran, Huyen, Trask, Nanette, Whitehead, Claire, Mahar, Robert, Hammond, Naomi, McFadyen, James David, Snelling, Thomas, Davis, Joshua, Denholm, Justin, Tong, Steven Y. C..
Blood ; 140:326-328, 2022.
Article in English | ScienceDirect | ID: covidwho-2120231
5.
BMJ ; 379: e072175, 2022 11 16.
Article in English | MEDLINE | ID: covidwho-2117032

ABSTRACT

OBJECTIVE: To determine whether disrupting the renin angiotensin system with angiotensin receptor blockers will improve clinical outcomes in people with covid-19. DESIGN: CLARITY was a pragmatic, adaptive, multicentre, phase 3, randomised controlled trial. SETTING: 17 hospital sites in India and Australia. PARTICIPANTS: Participants were at least 18 years old, previously untreated with angiotensin receptor blockers, with a laboratory confirmed diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection who had been admitted to hospital for management of covid-19. INTERVENTION: Oral angiotensin receptor blockers (telmisartan in India) or placebo (1:1) for 28 days. MAIN OUTCOME MEASURES: The primary endpoint was covid-19 disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at day 14. Secondary outcomes were WHO scale scores at day 28, mortality, intensive care unit admission, and respiratory failure. Analyses were evaluated on an ordinal scale in the intention-to-treat population. RESULTS: Between 3 May 2020 and 13 November 2021, 2930 people were screened for eligibility, with 393 randomly assigned to angiotensin receptor blockers (of which 388 (98.7%) to telmisartan 40 mg/day) and 394 to the control group. 787 participants were randomised: 778 (98.9%) from India and nine (1.1%) from Australia. The median WHO scale score at day 14 was 1 (interquartile range 1-1) in 384 participants assigned angiotensin receptor blockers and 1 (1-1) in 382 participants assigned placebo (adjusted odds ratio 1.51 (95% credible interval 1.02 to 2.23), probability of an odds ratio of >1 (Pr(OR>1)=0.98). WHO scale scores at day 28 showed little evidence of difference between groups (1.02 (0.55 to 1.87), Pr(OR>1)=0.53). The trial was stopped when a prespecified futility rule was met. CONCLUSIONS: In patients admitted to hospital for covid-19, mostly with mild disease, not requiring oxygen, no evidence of benefit, based on disease severity score, was found for treatment with angiotensin receptor blockers, using predominantly 40 mg/day of telmisartan. TRIAL REGISTRATION: ClinicalTrials.gov NCT04394117.


Subject(s)
Angiotensin Receptor Antagonists , COVID-19 Drug Treatment , Humans , Adolescent , Angiotensin Receptor Antagonists/therapeutic use , Telmisartan/therapeutic use , SARS-CoV-2 , Renin-Angiotensin System
7.
Nat Rev Nephrol ; 18(12): 779-793, 2022 12.
Article in English | MEDLINE | ID: covidwho-2036833

ABSTRACT

Peritoneal dialysis (PD) is an important home-based treatment for kidney failure and accounts for 11% of all dialysis and 9% of all kidney replacement therapy globally. Although PD is available in 81% of countries, this provision ranges from 96% in high-income countries to 32% in low-income countries. Compared with haemodialysis, PD has numerous potential advantages, including a simpler technique, greater feasibility of use in remote communities, generally lower cost, lesser need for trained staff, fewer management challenges during natural disasters, possibly better survival in the first few years, greater ability to travel, fewer dietary restrictions, better preservation of residual kidney function, greater treatment satisfaction, better quality of life, better outcomes following subsequent kidney transplantation, delayed need for vascular access (especially in small children), reduced need for erythropoiesis-stimulating agents, and lower risk of blood-borne virus infections and of SARS-CoV-2 infection. PD outcomes have been improving over time but with great variability, driven by individual and system-level inequities and by centre effects; this variation is exacerbated by a lack of standardized outcome definitions. Potential strategies for outcome improvement include enhanced standardization, monitoring and reporting of PD outcomes, and the implementation of continuous quality improvement programmes and of PD-specific interventions, such as incremental PD, the use of biocompatible PD solutions and remote PD monitoring.


Subject(s)
COVID-19 , Kidney Failure, Chronic , Peritoneal Dialysis , Child , Humans , Quality of Life , Renal Dialysis , SARS-CoV-2 , Peritoneal Dialysis/methods , Kidney Failure, Chronic/epidemiology , Kidney Failure, Chronic/therapy
8.
Glob Heart ; 16(1): 66, 2021.
Article in English | MEDLINE | ID: covidwho-2025129

ABSTRACT

The Coronavirus Disease 2019 (COVID-19) has had a continuous and robust impact on world health. The resulting COVID-19 pandemic has had a devastating physical, mental and fiscal impact on the millions of people living with noncommunicable diseases (NCDs). In addition to older age, people living with CVD, stroke, obesity, diabetes, kidney disease, and hypertension are at a particularly greater risk for severe forms of COVID-19 and its consequences. Meta-analysis indicates that hypertension, diabetes, chronic kidney disease, and thrombotic complications have been observed as both the most prevalent and most dangerous co-morbidities in COVID-19 patients. And despite the nearly incalculable physical, mental, emotional, and economic toll of this pandemic, forthcoming public health figures continue to place cardiovascular disease as the number one cause of death across the globe in the year 2020. The world simply cannot wait for the next pandemic to invest in NCDs. Social determinants of health cannot be addressed only through the healthcare system, but a more holistic multisectoral approach with at its basis the Sustainable Development Goals (SDGs) is needed to truly address social and economic inequalities and build more resilient systems. Yet there is reason for hope: the 2019 UN Political Declaration on UHC provides a strong framework for building more resilient health systems, with explicit calls for investment in NCDs and references to fiscal policies that put such investment firmly within reach. By further cementing the importance of addressing circulatory health in a future Framework Convention on Emergency Preparedness, WHO Member States can take concrete steps towards a pandemic-free future. As the chief representatives of the global circulatory health community and patients, the Global Coalition for Circulatory Health calls for increased support for the healthcare workforce, global vaccine equity, embracing new models of care and digital health solutions, as well as fiscal policies on unhealthy commodities to support these investments.


Subject(s)
COVID-19 , Noncommunicable Diseases , Aged , Global Health , Humans , Noncommunicable Diseases/epidemiology , Noncommunicable Diseases/prevention & control , Pandemics/prevention & control , SARS-CoV-2
9.
Kidney Int Rep ; 7(10): 2196-2206, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2015212

ABSTRACT

Introduction: Home dialysis may minimize SARS-CoV2 exposure risks compared to center-based dialysis. We explored how the pandemic may have introduced challenges related to peritoneal dialysis (PD) supply availability, routine patient care, and how facility practices changed during this time. Methods: The PD/Dialysis Outcomes and Practice Patterns Study (PDOPPS/DOPPS) and International Society of Nephrology (ISN) administered a web-based survey from November 2020 to March 2021. Medical director responses were compared across 10 ISN regions. Results: One hundered sixy-five PD facilities in 51 countries returned surveys. During the initial COVID-19 wave, the reported frequency of in-person patient visits decreased in 9 of 10 ISN regions. Before the pandemic, most facilities required a mask during PD exchanges which continued over the course of the pandemic. Although most facilities in different regions did not report PD supply disruptions, sites in Africa and South Asia reported major disruptions. Reductions in laparoscopic surgical procedures for PD catheters were reported by facilities in 9 of 10 regions whereas nonsurgical percutaneous procedures increased in facilities in 6 regions. Training of new PD patients declined in facilities in each region. Increased use of remote technology by patients to communicate with clinics was observed in all regions compared to prepandemic levels. Conclusion: Marked within-region and across-region variability was noted in PD facility burden, clinical practice, and adaptation to the COVID-19 pandemic. This study highlights opportunities to improve routine PD care, adapt to the ongoing pandemic, and increase preparedness for potential future interruptions in PD care.

10.
Nat Rev Nephrol ; 18(11): 724-737, 2022 11.
Article in English | MEDLINE | ID: covidwho-2000908

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has disproportionately affected patients with kidney disease, causing significant challenges in disease management, kidney research and trainee education. For patients, increased infection risk and disease severity, often complicated by acute kidney injury, have contributed to high mortality. Clinicians were faced with high clinical demands, resource shortages and novel ethical dilemmas in providing patient care. In this review, we address the impact of COVID-19 on the entire spectrum of kidney care, including acute kidney injury, chronic kidney disease, dialysis and transplantation, trainee education, disparities in health care, changes in health care policies, moral distress and the patient perspective. Based on current evidence, we provide a framework for the management and support of patients with kidney disease, infection mitigation strategies, resource allocation and support systems for the nephrology workforce.


Subject(s)
Acute Kidney Injury , COVID-19 , Humans , Pandemics , SARS-CoV-2 , Renal Dialysis , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Kidney
11.
Clinical kidney journal ; 2022.
Article in English | EuropePMC | ID: covidwho-1998886

ABSTRACT

Barriers to accessing home dialysis became a matter of life and death for many patients with kidney failure during the coronavirus disease 2019 (COVID-19) pandemic. Peritoneal dialysis (PD) is the more commonly used home therapy option. This article provides a comprehensive analysis of PD catheter insertion procedures as performed around the world today, barriers impacting timely access to the procedure, the impact of COVID-19 and a roadmap of potential policy solutions. To substantiate the analysis, the article includes a survey of institutions across the world, with questions designed to get a sense of the regulatory frameworks, barriers to conducting the procedure and impacts of the pandemic on capability and outcomes. Based on our research, we found that improving patient selection processes, determining and implementing correct insertion techniques, creating multidisciplinary teams, providing appropriate training and sharing decision making among stakeholders will improve access to PD catheter insertion and facilitate greater uptake of home dialysis. Additionally, on a policy level, we recommend efforts to improve the awareness and feasibility of PD among patients and the healthcare workforce, enhance and promulgate training for clinicians—both surgical and medical—to insert PD catheters and fund personnel, pathways and physical facilities for PD catheter insertion.

12.
Clin Kidney J ; 15(12): 2177-2185, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1927319

ABSTRACT

Barriers to accessing home dialysis became a matter of life and death for many patients with kidney failure during the coronavirus disease 2019 (COVID-19) pandemic. Peritoneal dialysis (PD) is the more commonly used home therapy option. This article provides a comprehensive analysis of PD catheter insertion procedures as performed around the world today, barriers impacting timely access to the procedure, the impact of COVID-19 and a roadmap of potential policy solutions. To substantiate the analysis, the article includes a survey of institutions across the world, with questions designed to get a sense of the regulatory frameworks, barriers to conducting the procedure and impacts of the pandemic on capability and outcomes. Based on our research, we found that improving patient selection processes, determining and implementing correct insertion techniques, creating multidisciplinary teams, providing appropriate training and sharing decision making among stakeholders will improve access to PD catheter insertion and facilitate greater uptake of home dialysis. Additionally, on a policy level, we recommend efforts to improve the awareness and feasibility of PD among patients and the healthcare workforce, enhance and promulgate training for clinicians-both surgical and medical-to insert PD catheters and fund personnel, pathways and physical facilities for PD catheter insertion.

13.
Kidney Dis (Basel) ; 8(5): 357-367, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-1909939

ABSTRACT

Background: The COVID-19 pandemic is challenging healthcare systems worldwide and has placed hospitals and healthcare providers (HCPs) at the center of a global crisis. Disruptions to hospital priorities, and limitations placed on the mobility of societies, have contributed to changes in the way HCPs and patients view and access dialysis for kidney failure, including which dialysis modality is preferred. Summary: This article explores the dialysis experience within the COVID-19 pandemic environment in the Asia Pacific region and presents evidence that peritoneal dialysis (PD) provides benefits to patients, HCPs, and health systems. As the number of people infected with COVID-19 has increased, the advantages of PD as a dialysis modality for limiting the spread of COVID-19 infection has been recognized. Key Message: The utility of PD has been demonstrated during the COVID-19 pandemic; thus, ensuring that the usage of PD is maintained and increased in a post-pandemic future is key. Such a scenario could enhance our ability to care for patients without interruption in circumstances of unforeseen obstacles and supports the ability of healthcare systems and patients to overcome barriers to dialysis access.

14.
BMJ Open ; 12(6): e059540, 2022 06 01.
Article in English | MEDLINE | ID: covidwho-1874561

ABSTRACT

OBJECTIVES: To determine whether hydroxychloroquine when used with personal protective equipment reduces the proportion of laboratory-confirmed COVID-19 among healthcare workers in comparison to the use of personal protective equipment alone. DESIGN: Multicentre, parallel-group, open-label randomised trial. Enrolment started on 29 June 2020 and stopped on 4 February 2021. Participants randomised in HydrOxychloroquine Prophylaxis Evaluation were followed for 6 months. SETTING: 9 hospitals across India. PARTICIPANTS: Healthcare workers in an environment with exposure to COVID-19 were randomised in a 1:1 ratio to hydroxychloroquine plus use of personal protective equipment or personal protective equipment alone. 886 participants were screened and 416 randomised (213 hydroxychloroquine arm and 203 personal protective equipment). INTERVENTION: Participants in intervention arm received 800 mg of hydroxychloroquine on day of randomisation and then 400 mg once a week for 12 weeks in addition to the use of personal protective equipment. In the control arm, participants continued to use personal protective equipment alone. MAIN OUTCOME: Proportion of laboratory-confirmed COVID-19 in the 6 months after randomisation. RESULTS: Participants were young (mean age 32.1 years, SD 9.1 years) with low-comorbid burden. 47.4% were female. In the 6 months after randomisation (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary endpoint (5.2% vs 5.9%; OR 0.85, 95% CI 0.35 to 2.07, p=0.72). There was no heterogeneity of treatment effect in any prespecified subgroup. There were no significant differences in the secondary outcomes. The adverse event rates were 9.9% and 6.9% in the hydroxychloroquine and standard practice arms, respectively. There were no serious adverse events in either group. CONCLUSIONS AND RELEVANCE: Hydroxychloroquine along with personal protective equipment was not superior to personal protective equipment alone on the proportion of laboratory-confirmed COVID-19. Definitive conclusions are precluded as the trial stopped early for futility, and hence was underpowered. TRIAL REGISTRATION NUMBER: CTRI/2020/05/025067.


Subject(s)
COVID-19 Drug Treatment , COVID-19 , Personal Protective Equipment , Adult , COVID-19/prevention & control , Female , Health Personnel , Humans , Hydroxychloroquine/therapeutic use , India/epidemiology , Male
15.
Clin Kidney J ; 15(7): 1312-1321, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1868268

ABSTRACT

Background: To investigate the anti-spike antibody response to vaccination in kidney transplant recipients (KTRs) previously infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as compared with KTRs with no history of coronavirus disease 2019 (COVID-19) from India. Methods: SARS-CoV-2 spike immunoglobulin (Ig) G antibody response was measured in 105 post-COVID-19 KTRs with PCR-confirmed SARS-CoV-2 infection who received either no vaccination (cohort 1), a single dose (cohort 2) or two doses (cohort 3) of vaccine and compared with 103 two-dose vaccinated COVID-19-naïve KTRs with no history of COVID-19 (cohort 4). Results: Out of 103 COVID-19-naïve two-dose vaccinated KTRs, <50% became seropositive with anti-spike antibody titres >50 arbitrary unit/mL subsequent to complete vaccination, the seroconversion rate being comparable in subjects receiving CovishieldTM versus CovaxinTM vaccines. However, the seropositive KTRs vaccinated with CovishieldTM had higher anti-spike antibody titres as compared with those who received CovaxinTM. We observed higher anti-SARS-CoV-2 spike antibody levels in post-COVID-19 KTRs after one dose of vaccine as compared with COVID-19-naïve two-dose vaccinated KTRs. Importantly, the second dose in post-COVID-19 KTRs did not significantly increase anti-spike antibody levels compared with the single-dose recipients. Conclusions: Our data present that in KTRs with previous SARS-CoV-2 infection, a single dose of vaccine (CovishieldTM) may be effective in mounting an optimal immune response. In contrast, COVID-19-naïve two-dose vaccinated KTRs respond poorly (<50%) to the current recommendation of a two-dose regimen in India.

16.
Trials ; 22(1): 573, 2021 Aug 28.
Article in English | MEDLINE | ID: covidwho-1817236

ABSTRACT

BACKGROUND: SARS-CoV-2 binds to membrane-bound angiotensin-converting enzyme 2 (ACE2) which may result in downregulation of membrane-bound ACE2. ACE2 is a key regulator of the renin-angiotensin system (RAS) and is responsible for degrading angiotensin II and thereby counteracting its pro-inflammatory, pro-fibrotic effects mediated through the angiotensin II type 1 receptor (AT1R). As AT1R is directly blocked by angiotensin receptor blockers (ARBs), these agents may offer a safe, low-cost solution for reducing COVID-19 respiratory outcomes. METHODS AND DISCUSSION: CLARITY is a pragmatic, adaptive, two-arm, multi-centre, comparative effectiveness phase III randomised controlled trial that examines whether ARBs reduce COVID-19 severity among high-risk patients. Recruiting in India and Australia, the trial will compare treatment with a maximum tolerated daily dose of an ARB to standard of care. Treatment allocation is blinded in India but open-label in Australia due to interruptions to placebo supply in the latter. The primary endpoint is a 7-point ordinal scale of clinical states, ranging from no limitation of activities (category 1) to death (category 7), assessed on day 14. Secondary outcomes include the 7-point scale assessed at day 28 and 28- and 90-day mortality. The design adapts the sample size based on accumulating data via frequent interim analyses and the use of predictive probability to determine whether the current sample size is sufficient or continuing accrual would be futile. The trial commenced recruitment on 18 August 2020. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04394117 . Registered on 19 May 2020. Clinical Trial Registry of India: CTRI/2020/07/026831).


Subject(s)
Angiotensin Receptor Antagonists , COVID-19 , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Renin-Angiotensin System , SARS-CoV-2
17.
Nephrology (Carlton) ; 27(5): 391-403, 2022 May.
Article in English | MEDLINE | ID: covidwho-1799261

ABSTRACT

Peritoneal dialysis (PD) has several advantages compared to haemodialysis (HD), but there is evidence showing underutilization globally, especially in low-income and lower-middle-income countries (LLMICs) where kidney replacement therapies (KRT) are often unavailable, inaccessible, and unaffordable. Only 11% of all dialysis patients worldwide use PD, more than 50% of whom live in China, the United States of America, Mexico, or Thailand. Various barriers to increased PD utilization have been reported worldwide including patient preference, low levels of education, and lower provider reimbursement. However, unique but surmountable barriers are applicable to LLMICs including the excessively high cost of providing PD (related to PD fluids in particular), excessive cost of treatment borne by patients (relative to HD), lack of adequate PD training opportunities for doctors and nurses, low workforce availability for kidney care, and challenges related to some PD outcomes (catheter-related infections, hospitalizations, mortality, etc.). This review discusses some known barriers to PD use in LLMICs and leverages data that show a global trend in reducing rates of PD-related infections, reducing rates of modality switches from HD, and improving patient survival in PD to discuss how PD use can be increased in LLMICs. We therefore, challenge the idea that low PD use in LLMICs is unavoidable due to these barriers and instead present opportunities to improve PD utilization in LLMICs.


Subject(s)
Kidney Failure, Chronic , Peritoneal Dialysis , Developing Countries , Dialysis Solutions , Humans , Kidney Failure, Chronic/diagnosis , Kidney Failure, Chronic/therapy , Peritoneal Dialysis/adverse effects , Renal Dialysis , United States
18.
BMJ : British Medical Journal (Online) ; 377, 2022.
Article in English | ProQuest Central | ID: covidwho-1784790

ABSTRACT

Tracking national legal frameworks to accelerate action on health for all

19.
Clinical kidney journal ; 2022.
Article in English | EuropePMC | ID: covidwho-1733205

ABSTRACT

Background To investigate the anti-spike antibody response to vaccination in Kidney transplant recipients (KTRs) previously infected with SARS-CoV-2 as compared to KTRs with no history of COVID-19 from India. Methods SARS-CoV-2 spike immunoglobulin (Ig) G antibody response was measured in 105 post COVID-19 KTRs with PCR confirmed SARS-CoV-2 infection who received either no vaccination (cohort 1), single (cohort 2) or two doses (cohort 3) of vaccine and compared to 103 two-dose vaccinated COVID-19 naïve KTRs with no history of COVID-19 (cohort 4). Results Out of 103 COVID-19 naïve two-dose vaccinated KTRs, less than 50% became seropositive with anti-spike antibody titres > 50AU/mL subsequent to complete vaccination, the seroconversion rate being comparable in subjects receiving CovishieldTM versus CovaxinTM vaccines. However, the seropositive KTRs vaccinated with CovishieldTM had higher anti-spike antibody titres as compared to those who received CovaxinTM. We observed higher anti-SARS-CoV-2 spike antibody levels in post COVID-19 KTRs after 1 dose of vaccine as compared with COVID-19 naïve two-dose vaccinated KTRs. Importantly, the second dose in post COVID-19 KTRs did not significantly increase anti-spike antibody levels compared with the single dose recipients. Conclusions Our data presents that in KTRs with previous SARS-CoV-2 infection a single dose of vaccine (CovishieldTM) may be effective in mounting optimal immune response. In contrast, COVID-19 naïve two-dose vaccinated KTRs respond poorly (<50%) to current recommendation of a two-dose regimen in India.

20.
Kidney Int Rep ; 7(5): 971-982, 2022 May.
Article in English | MEDLINE | ID: covidwho-1734374

ABSTRACT

Introduction: It is unknown how the COVID-19 pandemic has affected the care of vulnerable chronic hemodialysis (HD) patients across regions, particularly in low and lower-middle income countries (LLMICs). We aimed to identify global inequities in HD care delivery during the COVID-19 pandemic. Methods: The ISN and the Dialysis Outcomes and Practice Patterns Study (DOPPS) conducted a global online survey of HD units between March and November, 2020, to ascertain practice patterns and access to resources relevant to HD care during the COVID-19 pandemic. Responses were categorized according to World Bank income classification for comparisons. Results: Surveys were returned from 412 facilities in 78 countries: 15 (4%) in low-income countries (LICs), 111 (27%) in lower-middle income countries (LMICs), 145 (35%) in upper-middle income countries (UMICs), and 141 (34%) in high-income countries (HICs). Respondents reported that diagnostic tests for SARS-CoV-2 were unavailable or of limited availability in LICs (72%) and LMICs (68%) as compared with UMICs (33%) and HICs (20%). The number of patients who missed HD treatments was reported to have increased during the COVID-19 pandemic in LICs (64%) and LMICs (67%) as compared with UMICs (31%) and HICs (6%). Limited access to HD, intensive care unit (ICU) care, and mechanical ventilation among hospitalized patients on chronic dialysis with COVID-19 were also reportedly higher in LICs and LMICs as compared with UMICs and HICs. Staff in LLMICs reported less routine testing for SARS-CoV-2 when asymptomatic as compared with UMICs and HICs-14% in LICs and 11% in LMICs, compared with 26% and 28% in UMICs and HICs, respectively. Severe shortages of personal protective equipment (PPE) were reported by the respondents from LICs and LMICs compared with UMICs and HICs, especially with respect to the use of the N95 particulate-air respirator masks. Conclusion: Striking global inequities were identified in the care of chronic HD patients during the pandemic. Urgent action is required to address these inequities which disproportionately affect LLMIC settings thereby exacerbating pre-existing vulnerabilities that may contribute to poorer outcomes.

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