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• W4296803319 abstract "Oral nirmatrelvir/ritonavir (Paxlovid®) aims to avoid severe COVID-19 in asymptomatic people or those with mild symptoms, thereby decreasing hospitalization and death. Due to its novelty, there are currently few published study results. It remains to be evaluated for which indications and patient populations the drug is suitable. OBJECTIVES: To assess the efficacy and safety of nirmatrelvir/ritonavir (Paxlovid®) plus standard of care compared to standard of care with or without placebo, or any other intervention for treating COVID-19 and for preventing SARS-CoV-2 infection. To explore equity aspects in subgroup analyses. To keep up to date with the evolving evidence base using a living systematic review (LSR) approach and make new relevant studies available to readers in-between publication of review updates.We searched the Cochrane COVID-19 Study Register, Scopus, and WHO COVID-19 Global literature on coronavirus disease database, identifying completed and ongoing studies without language restrictions and incorporating studies up to 11 July 2022. This is a LSR. We conduct monthly update searches that are being made publicly available on the open science framework (OSF) platform.Studies were eligible if they were randomized controlled trials (RCTs) comparing nirmatrelvir/ritonavir plus standard of care with standard of care with or without placebo, or any other intervention for treatment of people with confirmed COVID-19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS-CoV-2 infection. We screened all studies for research integrity. Studies were ineligible if they had been retracted, or if they were not prospectively registered including appropriate ethics approval.We followed standard Cochrane methodology and used the Cochrane risk of bias 2 tool. We rated the certainty of evidence using the GRADE approach for the following outcomes: 1. to treat outpatients with mild COVID-19; 2. to treat inpatients with moderate-to-severe COVID-19: mortality, clinical worsening or improvement, quality of life, (serious) adverse events, and viral clearance; 3. to prevent SARS-CoV-2 infection in post-exposure prophylaxis (PEP); and 4. pre-exposure prophylaxis (PrEP) scenarios: SARS-CoV-2 infection, development of COVID-19 symptoms, mortality, admission to hospital, quality of life, and (serious) adverse events. We explored inequity by subgroup analysis for elderly people, socially-disadvantaged people with comorbidities, populations from LICs and LMICs, and people from different ethnic and racial backgrounds.As of 11 July 2022, we included one RCT with 2246 participants in outpatient settings with mild symptomatic COVID-19 comparing nirmatrelvir/ritonavir plus standard of care with standard of care plus placebo. Trial participants were unvaccinated, without previous confirmed SARS-CoV-2 infection, had a symptom onset of no more than five days before randomization, and were at high risk for progression to severe disease. Prohibited prior or concomitant therapies included medications highly dependent on CYP3A4 for clearance and CYP3A4 inducers. We identified eight ongoing studies. Nirmatrelvir/ritonavir for treating COVID-19 in outpatient settings with asymptomatic or mild disease For the specific population of unvaccinated, high-risk patients nirmatrelvir/ritonavir plus standard of care compared to standard of care plus placebo may reduce all-cause mortality at 28 days (risk ratio (RR) 0.04, 95% confidence interval (CI) 0.00 to 0.68; 1 study, 2224 participants; estimated absolute effect: 11 deaths per 1000 people receiving placebo compared to 0 deaths per 1000 people receiving nirmatrelvir/ritonavir; low-certainty evidence, and admission to hospital or death within 28 days (RR 0.13, 95% CI 0.07 to 0.27; 1 study, 2224 participants; estimated absolute effect: 61 admissions or deaths per 1000 people receiving placebo compared to eight admissions or deaths per 1000 people receiving nirmatrelvir/ritonavir; low-certainty evidence). Nirmatrelvir/ritonavir plus standard of care may reduce serious adverse events during the study period compared to standard of care plus placebo (RR 0.24, 95% CI 0.15 to 0.41; 1 study, 2224 participants; low-certainty evidence). Nirmatrelvir/ritonavir plus standard of care probably has little or no effect on treatment-emergent adverse events (RR 0.95, 95% CI 0.82 to 1.10; 1 study, 2224 participants; moderate-certainty evidence), and probably increases treatment-related adverse events such as dysgeusia and diarrhoea during the study period compared to standard of care plus placebo (RR 2.06, 95% CI 1.44 to 2.95; 1 study, 2224 participants; moderate-certainty evidence). Nirmatrelvir/ritonavir plus standard of care probably decreases discontinuation of study drug due to adverse events compared to standard of care plus placebo (RR 0.49, 95% CI 0.30 to 0.80; 1 study, 2224 participants; moderate-certainty evidence). No study results were identified for improvement of clinical status, quality of life, and viral clearance. Subgroup analyses for equity Most study participants were younger than 65 years (87.1% of the : modified intention to treat (mITT1) population with 2085 participants), of white ethnicity (71.5%), and were from UMICs or HICs (92.1% of study centres). Data on comorbidities were insufficient. The outcome 'admission to hospital or death' was investigated for equity: age (< 65 years versus ≥ 65 years) and ethnicity (Asian versus Black versus White versus others). There was no difference between subgroups of age. The effects favoured treatment with nirmatrelvir/ritonavir for the White ethnic group. Estimated effects in the other ethnic groups included the line of no effect (RR = 1). No subgroups were reported for comorbidity status and World Bank country classification by income level. No subgroups were reported for other outcomes. Nirmatrelvir/ritonavir for treating COVID-19 in inpatient settings with moderate to severe disease No studies available. Nirmatrelvir/ritonavir for preventing SARS-CoV-2 infection (PrEP and PEP) No studies available.There is low-certainty evidence that nirmatrelvir/ritonavir reduces the risk of all-cause mortality and hospital admission or death based on one trial investigating unvaccinated COVID-19 participants without previous infection that were at high risk and with symptom onset of no more than five days. There is low- to moderate-certainty evidence that nirmatrelvir/ritonavir is safe in people without prior or concomitant therapies including medications highly dependent on CYP3A4. Regarding equity aspects, except for ethnicity, no differences in effect size and direction were identified. No evidence is available on nirmatrelvir/ritonavir to treat hospitalized people with COVID-19 and to prevent a SARS-CoV-2 infection. We will continually update our search and make search results available on OSF." @default.
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• W4296803319 date "2022-09-20" @default.
• W4296803319 modified "2023-10-10" @default.
• W4296803319 title "Nirmatrelvir combined with ritonavir for preventing and treating COVID-19" @default.
• W4296803319 cites W1979091677 @default.
• W4296803319 cites W2027484375 @default.
• W4296803319 cites W2031720106 @default.
• W4296803319 cites W2075642745 @default.
• W4296803319 cites W2088095316 @default.
• W4296803319 cites W2135400982 @default.
• W4296803319 cites W2464924628 @default.
• W4296803319 cites W2970684805 @default.
• W4296803319 cites W3000410309 @default.
• W4296803319 cites W3001118548 @default.
• W4296803319 cites W3008028633 @default.
• W4296803319 cites W3009335299 @default.
• W4296803319 cites W3009881183 @default.
• W4296803319 cites W3011398105 @default.
• W4296803319 cites W3011701533 @default.
• W4296803319 cites W3020300207 @default.
• W4296803319 cites W3025391403 @default.
• W4296803319 cites W3028583791 @default.
• W4296803319 cites W3029338293 @default.
• W4296803319 cites W3033306974 @default.
• W4296803319 cites W3034858522 @default.
• W4296803319 cites W3036796082 @default.
• W4296803319 cites W3038070845 @default.
• W4296803319 cites W3046101830 @default.
• W4296803319 cites W3047144258 @default.
• W4296803319 cites W3081491793 @default.
• W4296803319 cites W3081745349 @default.
• W4296803319 cites W3084851377 @default.
• W4296803319 cites W3090082271 @default.
• W4296803319 cites W3094827588 @default.
• W4296803319 cites W3095153958 @default.
• W4296803319 cites W3111079131 @default.
• W4296803319 cites W3113692632 @default.
• W4296803319 cites W3120387768 @default.
• W4296803319 cites W3134061302 @default.
• W4296803319 cites W3154346966 @default.
• W4296803319 cites W3156249792 @default.
• W4296803319 cites W3157086503 @default.
• W4296803319 cites W3165479483 @default.
• W4296803319 cites W3189646261 @default.
• W4296803319 cites W3196324863 @default.
• W4296803319 cites W3207150419 @default.
• W4296803319 cites W3212389527 @default.
• W4296803319 cites W4200026214 @default.
• W4296803319 cites W4200206478 @default.
• W4296803319 cites W4200338098 @default.
• W4296803319 cites W4200349447 @default.
• W4296803319 cites W4210736465 @default.
• W4296803319 cites W4211052454 @default.
• W4296803319 cites W4214552635 @default.
• W4296803319 cites W4221097092 @default.
• W4296803319 cites W4223559309 @default.
• W4296803319 cites W4225338642 @default.
• W4296803319 cites W4226164088 @default.
• W4296803319 cites W4226236384 @default.
• W4296803319 cites W4226240956 @default.
• W4296803319 cites W4237690308 @default.
• W4296803319 cites W4246271978 @default.
• W4296803319 cites W4281729807 @default.
• W4296803319 cites W4283205481 @default.
• W4296803319 cites W4293426219 @default.
• W4296803319 cites W4296803319 @default.
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• W4296803319 doi "https://doi.org/10.1002/14651858.cd015395.pub2" @default.
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