Systematic review and meta-analysis of effectiveness and safety of favipiravir in the management of novel coronavirus (COVID-19) patients.
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ABSTRACT:
SUBMITTER: Prakash A
PROVIDER: S-EPMC8025763 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionAn outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was reported in Wuhan, China, in mid-December 2019, and declared a pandemic by the WHO on 11 March 2020. Due to the unknown nature of the disease and the lack of specific drugs, several potential treatments were used for patients. This systematic review and meta-analysis will evaluate studies of the effects of favipiravir in COVID-19 pneumonia.Methods and analysisWe will search electronic databases including LitCovid hub, PubMed, Scopus, ISI Web of Sciences, Cochrane and Embase using keywords related to COVID-19 and favipiravir. We will search the reference lists of all included studies and reviews. We will also search for clinical trial registries, such as ClinicalTrials.gov, for the ongoing clinical trials. All randomised clinical trials investigating the safety and efficacy of favipiravir compared with other control groups for the treatment of patients with confirmed infection with SARS-CoV-2 will be included. Patients' survival at the end of the treatment as well as the follow-up will be the primary outcome of the treatment, followed by the time and rate of the patient with a negative COVID-19 test. The desired secondary outcome will consist of a decreased rate of symptoms, proportion of intensive care unit (ICU) transfers, length of the hospital stay, ICU treatments, the quality of life and additional adverse events. Data synthesis will be conducted using CMA V.2. Two independent investigators will be screening titles, abstracts and full texts of included studies, based on eligibility criteria. These investigators will then independently extract the data and appraise the quality of said studies. All potential discrepancies will be resolved through consultation with the third reviewer. Statistical heterogeneity will be assessed using a standard I2 test. A funnel plot, Egger's test and Begg's test will be used for detecting asymmetry to explore possible publication bias.Ethics and disseminationAll findings of this systematic review and meta-analysis will help identify the safety and efficacy of favipiravir for patients with COVID-19. Given that the design of the study is a systematic review, there is no need to follow the code of ethics protocol. The results of this study will be published in a reputable journal.Prospero registration numberCRD42020180032.
| S-EPMC7397976 | biostudies-literature
Project description:The novel coronavirus outbreak began in late December 2019 and rapidly spread worldwide, critically impacting public health systems. A number of already approved and marketed drugs are being tested for repurposing, including Favipiravir. We aim to investigate the efficacy and safety of Favipiravir in treatment of COVID-19 patients through a systematic review and meta-analysis. This systematic review and meta-analysis were reported in accordance with the PRISMA statement. We registered the protocol in the PROSPERO (CRD42020180032). All clinical trials which addressed the safety and efficacy of Favipiravir in comparison to other control groups for treatment of patients with confirmed infection with SARS-CoV2 were included. We searched electronic databases including LitCovid/PubMed, Scopus, Web of Sciences, Cochrane, and Scientific Information Database up to 31 December 2020. We assessed the risk of bias of the included studies using Cochrane Collaboration criteria. All analyses were performed using the Comprehensive Meta-Analysis software version 2, and the risk ratio index was calculated. Egger and Begg test was used for assessing publication bias. Nine studies were included in our meta-analysis. The results of the meta-analysis revealed a significant clinical improvement in the Favipiravir group versus the control group during seven days after hospitalization (RR = 1.24, 95% CI: 1.09-1.41; P = 0.001). Viral clearance was more in 14 days after hospitalization in Favipiravir group than control group, but this finding marginally not significant (RR = 1.11, 95% CI: 0.98-1.25; P = 0.094). Requiring supplemental oxygen therapy in the Favipiravir group was 7% less than the control group, (RR = 0.93, 95% CI: 0.67-1.28; P = 0.664). Transferred to ICU and adverse events were not statistically different between two groups. The mortality rate in the Favipiravir group was approximately 30% less than the control group, but this finding not statistically significant. Favipiravir possibly exerted no significant beneficial effect in the term of mortality in the general group of patients with mild to moderate COVID-19. We should consider that perhaps the use of antiviral once the patient has symptoms is too late and this would explain their low efficacy in the clinical setting.
| S-EPMC8155021 | biostudies-literature
Project description:BackgroundFavipiravir possesses high utility for treating patients with COVID-19. However, research examining the efficacy and safety of favipiravir for patients with COVID-19 is limited.MethodsWe conducted a systematic review of published studies reporting the efficacy of favipiravir against COVID-19. Two investigators independently searched PubMed, the Cochrane Database of Systematic Reviews, MedRxiv, and ClinicalTrials.gov (inception to September 2020) to identify eligible studies. A meta-analysis was performed to measure viral clearance and clinical improvement as the primary outcomes.ResultsAmong 11 eligible studies, 5 included a comparator group. Comparing to the comparator group, the favipiravir group exhibited significantly better viral clearance on day 7 after the initiation of treatment (odds ratio [OR] = 2.49, 95% confidence interval [CI] = 1.19-5.22), whereas no difference was noted on day 14 (OR = 2.19, 95% CI = 0.69-6.95). Although clinical improvement was significantly better in the favipiravir group on both days 7 and 14, the improvement was better on day 14 (OR = 3.03, 95% CI = 1.17-7.80) than on day 7 (OR = 1.60, 95% CI = 1.03-2.49). The estimated proportions of patients with viral clearance in the favipiravir arm on days 7 and 14 were 65.42 and 88.9%, respectively, versus 43.42 and 78.79%, respectively, in the comparator group. The estimated proportions of patients with clinical improvement on days 7 and 14 in the favipiravir group were 54.33 and 84.63%, respectively, compared with 34.40 and 65.77%, respectively, in the comparator group.ConclusionsFavipiravir induces viral clearance by 7 days and contributes to clinical improvement within 14 days. The results indicated that favipiravir has strong possibility for treating COVID-19, especially in patients with mild-to-moderate illness. Additional well-designed studies, including examinations of the dose and duration of treatment, are crucial for reaching definitive conclusions.
| S-EPMC8159019 | biostudies-literature
Project description:We conducted this systemic review and meta-analysis in an attempt to evaluate the efficacy and safety of umifenovir in coronavirus disease 2019 (COVID-19). We searched PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure, and medRxiv database. We included both retrospective and prospective studies. The mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) were applied to assess the effectiveness of umifenovir for COVID-19. A total of 12 studies with 1052 patients were included in our final studies. Compared with control group, umifenovir was associated with higher negative rate of PCR on day 14 (RR:1.27; 95% CI: 1.04 to 1.55). However, umifenovir is not related to nucleus acid negative conversion time (MD: 0.09; 95% CI: -1.48 to 1.65), negative rate on day 7 (RR:1.09; 95% CI: 0.91 to 1.31), incidence of composite endpoint (RR:1.20; 95% CI: 0.61 to 2.37), rate of fever alleviation on day 7 (RR:1.00; 95% CI: 0.91 to 1.10), rate of cough alleviation on day 7 (RR:1.00; 95% CI: 0.85 to 1.18), or hospital length of stay (MD: 1.34; 95% CI: -2.08 to 4.76). Additionally, umifenovir was safe in COVID-19 patients (RR for incidence of adverse events: 1.29; 95% CI: 0.57 to 2.92). The results of sensitivity analysis and subgroup analysis were similar to pooled results. There is no evidence to support the use of umifenovir for improving patient-important outcomes in patients with COVID-19.
| S-EPMC7361300 | biostudies-literature
Project description:IntroductionWe conducted a comprehensive literature review to synthesize evidence for the relationship between corticosteroid use and mortality in patients with COVID-19.MethodsThe PUBMED, EMBASE, and Cochrane Library were searched from inception to March 13, 2021. We searched and analyzed randomized controlled trials (RCTs) and observational studies (OSs) that examined corticosteroid use in patients with COVID-19. The primary outcome was in-hospital mortality, while the secondary outcome was the need for mechanical ventilation (MV) and serious adverse events.ResultsA total of 11 RCTs and 44 OSs involving 7893 and 41,164 patients with COVID-19 were included in the study. Corticosteroid use was associated with lower COVID-19 mortality in RCTs, but was not statistically significant (OR 0.91, 95% CI 0.77-1.07; I2 = 63.4%). The subgroup analysis of pulse dose corticosteroid showed survival benefit statistically (OR 0.29, 95% CI 0.15-0.56). Moreover, the corticosteroid use may reduce the need for MV (OR 0.67, 95% CI 0.51-0.90; I2 = 7.5%) with no significant increase in serious adverse reactions (OR 0.84, 95% CI 0.30-2.37; I2 = 33.3%). In addition, the included OSs showed that the pulse dose (OR 0.66, 95% CI 0.45-0.95; I2 = 30.8%) might lower the mortality in patients with COVID-19. The pulse dose of methylprednisolone (OR 0.60, 95% CI 0.45-0.80; I2 = 0%) had a beneficial effect on survival. It was especially significant when the duration of pulse methylprednisolone use was less than 7 days (OR 0.59, 95% CI 0.43-0.80; I2 = 0%).ConclusionsThis meta-analysis indicated that corticosteroid use might cause a slight reduction in COVID-19 mortality. However, it could significantly reduce the MV requirement in patients with COVID-19 and restrict serious adverse events. Additionally, the pulse dose of methylprednisolone for less than 7 days may be a good treatment choice for patients with COVID-19.
| S-EPMC8363240 | biostudies-literature
Project description:BackgroundAlthough multiple studies have revealed that coronavirus disease 2019 (COVID-19) vaccines can reduce COVID-19-related outcomes, little is known about their impact on post-COVID-19 conditions. We performed a systematic literature review and meta-analysis on the effectiveness of COVID-19 vaccination against post-COVID-19 conditions (ie, long COVID).MethodsWe searched PubMed, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from December 1, 2019, to April 27, 2022, for studies evaluating COVID-19 vaccine effectiveness against post-COVID-19 conditions among individuals who received at least 1 dose of Pfizer/BioNTech, Moderna, AstraZeneca, or Janssen vaccine. A post-COVID-19 condition was defined as any symptom that was present 3 or more weeks after having COVID-19. Editorials, commentaries, reviews, study protocols, and studies in the pediatric population were excluded. We calculated the pooled diagnostic odds ratios (DORs) for post-COVID-19 conditions between vaccinated and unvaccinated individuals. Vaccine effectiveness was estimated as 100% × (1 - DOR).ResultsIn total, 10 studies with 1,600,830 individuals evaluated the effect of vaccination on post-COVID-19 conditions, of which 6 studies were included in the meta-analysis. The pooled DOR for post-COVID-19 conditions among individuals vaccinated with at least 1 dose was 0.708 (95% confidence interval (CI), 0.692-0.725) with an estimated vaccine effectiveness of 29.2% (95% CI, 27.5%-30.8%). The vaccine effectiveness was 35.3% (95% CI, 32.3%-38.1%) among those who received the COVID-19 vaccine before having COVID-19, and 27.4% (95% CI, 25.4%-29.3%) among those who received it after having COVID-19.ConclusionsCOVID-19 vaccination both before and after having COVID-19 significantly decreased post-COVID-19 conditions for the circulating variants during the study period although vaccine effectiveness was low.
| S-EPMC9726631 | biostudies-literature
Project description:In the coronavirus disease 2019 (COVID-19) pandemic, vaccinations were essential in preventing COVID-19 infections and related mortality in older adults. The objectives of this study were to evaluate the effectiveness and safety of the COVID-19 vaccines in older adults. We systematically searched the electronic bibliographic databases of PubMed, Web of Science, Embase, Cochrane Library, ClinicalTrials.gov, Research Square, and OpenGrey, as well as other sources of gray literature, for studies published between January 1, 2020, and October 1, 2022. We retrieved 22 randomized controlled trials (RCTs), with a total of 3,404,696 older adults (aged over 60 years) participating, that were included in the meta-analysis. No significant publication bias was found. In the cumulative meta-analysis, we found that the COVID-19 vaccines were effective in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (OR = 0.38, 95% CI = 0.23-0.65, p = 0.0004) and in reducing the number of COVID-19-related deaths (OR = 0.16, 95% CI = 0.10-0.25, p < 0.00001) in elderly people. Antibody seroconversion (AS) and geometric mean titer (GMT) levels significantly increased in vaccinated older adults [OR = 24.42, 95% CI = 19.29-30.92; standardized mean difference (SMD) = 0.92, 95% CI = 0.64-1.20, respectively]. However, local and systemic adverse events after COVID-19 vaccine administration were found in older adults (OR = 2.57, 95% CI = 1.83-3.62, p < 0.00001). Although vaccination might induce certain adverse reactions in the elderly population, the available evidence showed that the COVID-19 vaccines are effective and tolerated, as shown by the decrease in COVID-19-related deaths in older adults. It needs to be made abundantly clear to elderly people that the advantages of vaccination far outweigh any potential risks. Therefore, COVID-19 vaccination should be considered as the recommended strategy for the control of this disease by preventing SARS-CoV-2 infection and related deaths in older adults. More RCTs are needed to increase the certainty of the evidence and to verify our conclusions.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022319698, identifier CRD42022319698.
| S-EPMC10020204 | biostudies-literature
Project description:Introduction: Until now, there is no clinically approved specific medicine to treat COVID-19. Prior systematic reviews (SRs) have shown that traditional Chinese medicine (TCM) reduces the number of patients with severe disease and time to fever clearance, promotes clinical effectiveness, and improves chest images and the negativity rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test. Few SRs arrived at a definitive conclusion, and more randomized controlled trials (RCTs) were published. We conducted this study to summarize the latest evidence of TCM in COVID-19. Methods: Eight online databases were searched from December 2019 to July 2020, updated to March 2021. Only RCTs evaluating the clinical efficacy and safety of TCM in the treatment of COVID-19 were included. Primary outcomes were clinical cure and the negativity of the SARS-CoV-2 nucleic acid test. Secondary outcomes included clinical deterioration, ARDS, mechanical ventilation, death, time to fever clearance, duration of hospitalization, and chest imaging improvement. Safety outcomes included adverse events and serious adverse events during treatment. Two reviewers selected the included articles, assessed the risk of bias, and extracted data independently and in duplicate. Results: A total of 25 RCTs involving 2222 participants were selected in the systematic review, and seven RCTs were included in the meta-analysis. The results showed that TCM plus routine treatment was significantly better than routine treatment alone in clinical cure (risk ratio [RR] = 1.20, 95% confidence interval (CI) [1.04, 1.38], P = 0.01) and chest image improvement (RR = 1.22, 95% CI [1.07, 1.39], P = 0.01) and could reduce clinical deterioration (RR = 0.39, 95% CI [0.18, 0.86], P = 0.02), ARDS (RR = 0.28, 95% CI [0.11, 0.69], P = 0.01), mechanical ventilation (RR = 0.30, 95% CI [0.12, 0.77], P = 0.01), or death rate (RR = 0.28, 95% CI [0.09, 0.84], P = 0.02). No significant difference between TCM and routine treatment in the negativity of SARS-CoV-2 nucleic acid test (RR = 1.08, 95% CI [0.94, 1.23], P = 0.29) was observed. Finally, there was no overall significant difference in the incidence of adverse events between the two groups. The summary of evidence showed moderate confidence of a benefit of 11.8% in clinical cure and 14.0% in chest image improvement and a reduction of 5.9% in clinical deterioration, 25.4% in ARDS, 18.3% in mechanical ventilation, and 4.5% in death with TCM plus routine treatment compared to routine treatment alone in patients with COVID-19. A low confidence of a benefit of 5.4% in the negativity of SARS-CoV-2 nucleic acid test was also observed. Conclusions: Synethized evidence of 21 outcomes in 8 RCTs showed moderate certainty that TCM treatment plus routine treatment may promote a clinical cure and chest image improvement compared to routine treatment alone while reducing clinical deterioration, development of ARDS, use of mechanical ventilation, and death in patients with COVID-19. TCM treatment plus routine treatment may not promote the negativity of the SARS-CoV-2 nucleic acid test compared to routine treatment alone. TCM treatment was found to be safe for patients with COVID-19.
| S-EPMC8379002 | biostudies-literature
Project description:IntroductionNumerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions.Methods and analysisWe aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.
| S-EPMC9981247 | biostudies-literature
Project description:IntroductionIvermectin is a drug with antiviral properties and has been proposed as an alternative treatment for patients with COVID-19, in some countries; however, there is limited evidence to support its clinical use. Accordingly, the aim of this review and meta-analysis is to obtain superior evidence on the effectiveness and safety of ivermectin in treatment of COVID-19.Methods and analysisWe will search in the medical databases and International Clinical Trials Registry Platform databases for randomised clinical trials and quasi-randomised trials published from December 2019. The criteria for inclusion are that infection needs to be confirmed by a real-time PCR or serology test, and the effect of ivermectin has been compared with placebo, symptomatic treatment or no treatment. We will exclude observational studies and clinical trials that involved patients with symptoms suggestive of COVID-19, but without a laboratorial diagnosis. Outcomes of interest include mortality, time to symptom resolution, time of hospitalisation, frequency of invasive mechanical ventilation and extracorporeal membrane oxygenation, incidence of severe acute respiratory syndrome, admission to intensive care unit, viral load, PCR-negative status, percentage of infection after prophylactic use, and total incidence of adverse and side effects. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two reviewers will independently select the studies and assess their eligibility. Two other reviewers will independently extract data from each study. Meta-analysis will then be carried out using fixed-effects or random-effects model, using the mean difference for continuous outcomes and the relative risk for dichotomous outcomes. Bias risk will be assessed using the Cochrane risk-of-bias tool. The quality of evidence for each outcome will be assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. Review Manager V.5.3.5 will be used for synthesis and subgroup analysis.Ethics and disseminationOwing to the nature of the review, ethical approval is not required. The results will be disseminated through peer-reviewed publications.Prospero registration numberCRD42020197395.
| S-EPMC8450968 | biostudies-literature