What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis

Background and aim Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-up biopsy. Methods We conducted a systematic review of MEDLINE and Embase until May 2020 and included randomized clinical trials of any intervention in non-alcoholic steatohepatitis with at least 1-year follow-up. We were guided by Cochrane methods to run a meta-analysis with generalized linear mixed models with random effects. Results Forty-one trials (n = 6,695) were included. The proportion of participants with a valid follow-up biopsy was 82% (95%CI: 78%-86%, I2 = 92%). There was no evidence of a difference by location, trial length, or by allocated treatment group. Reasons for missing follow-up biopsies were, in ranked order, related to participants (95 per 1,000 participants (95%CI: 69–129, I2 = 92%), medical factors, protocol, trial conduct, and other/unclear. Biopsy-related serious adverse events occurred in 16 per 1,000 participants (95% CI: 8–33, I2 = 54%). No biopsy-related deaths were reported. Conclusions The proportion of participants with a valid follow-up biopsy in therapeutic trials in non-alcoholic steatohepatitis is on average 82%, with around 1 in 10 participants declining a follow-up biopsy. These findings can inform adequately-powered trials.

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Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

Systematic Reviews ◽

10.1186/s13643-020-01516-1 ◽

2020 ◽

Vol 9 (1) ◽

Author(s):

Steven Kwasi Korang ◽

Sophie Juul ◽

Emil Eik Nielsen ◽

Joshua Feinberg ◽

Faiza Siddiqui ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Individual Patient Data ◽

Viral Vector ◽

Meta Analysis ◽

Risk Of Bias ◽

Serious Adverse Events ◽

Meta Analyses ◽

Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

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Exercise-Based Interventions to Enhance Long-Term Sustainability of Physical Activity in Older Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16142527 ◽

2019 ◽

Vol 16 (14) ◽

pp. 2527 ◽

Cited By ~ 13

Author(s):

Sansano-Nadal ◽

Giné-Garriga ◽

Brach ◽

Wert ◽

Jerez-Roig ◽

...

Keyword(s):

Systematic Review ◽

Older Adults ◽

Active Control ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Community Dwelling ◽

Exercise Interventions ◽

Mean Differences

Exercise is a form of physical activity (PA). PA is an important marker of health and quality of life in older adults. The purpose of this study was to conduct a systematic review of the literature to assess the effect of exercise-based interventions on an at least six-month follow up PA measure, and to describe the specific strategies implemented during the intervention to strengthen the sustainability of PA in community-dwelling 65+ year-old adults. We registered and conducted a systematic review and meta-analysis (PROSPERO: CRD42017070892) of randomized clinical trials (RCT). We searched three electronic databases during January 2018 to identify RCT assessing any type of exercise-based intervention. Studies had to report a pre-, post-, and at least 6-month post-intervention follow-up. To be included, at least one PA outcome had to be assessed. The effect of exercise-based interventions was assessed compared to active (e.g., a low-intensity type of exercise, such as stretching or toning activities) and non-active (e.g., usual care) control interventions at several time points. Secondary analyses were conducted, restricted to studies that reported specific strategies to enhance the sustainability of PA. The intervention effect was measured on self-reported and objective measures of time spent in PA, by means of standardized mean differences. Standardized mean differences of PA level were pooled. Pooled estimates of effect were computed with the DerSimonian–Laird method, applying a random effects model. The risk of bias was also assessed. We included 12 studies, comparing 18 exercise intervention groups to four active and nine non-active control groups. Nine studies reported specific strategies to enhance the long-term sustainability of PA. The strategies were mostly related to the self-efficacy, self-control, and behavior capability principles based on the social cognitive theory. Exercise interventions compared to active control showed inconclusive and heterogeneous results. When compared to non-active control, exercise interventions improved PA time at the six-months follow up (standardized mean difference (SMD) 0.30; 95%CI 0.15 to 0.44; four studies; 724 participants; I2 0%), but not at the one- or two-years follow-ups. No data were available on the mid- and long-term effect of adding strategies to enhance the sustainability of PA. Exercise interventions have small clinical benefits on PA levels in community-dwelling older adults, with a decline in the observed improvement after six months of the intervention cessation.

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Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis

Jornal Brasileiro de Pneumologia ◽

10.1590/s1806-37562016000000287 ◽

2017 ◽

Vol 43 (4) ◽

pp. 302-312 ◽

Cited By ~ 5

Author(s):

Israel Silva Maia ◽

Mariângela Pimentel Pincelli ◽

Victor Figueiredo Leite ◽

João Amadera ◽

Anna Maria Buehler

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Therapeutic Effects ◽

Muscarinic Antagonists ◽

Serious Adverse Events ◽

Exacerbation Rate ◽

Copd Exacerbations ◽

Long Acting

ABSTRACT Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations. Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. Results: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. Conclusions: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.

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Is oral lichen planus a risk factor for peri-implant diseases? A systematic review and meta-analysis

10.21203/rs.3.rs-15960/v1 ◽

2020 ◽

Author(s):

Xiaoqin Xiong ◽

Ting Yu ◽

Tiantian Xu ◽

Xinhong Wang ◽

Wenguang Qin ◽

...

Keyword(s):

Systematic Review ◽

Risk Factor ◽

Lichen Planus ◽

Oral Lichen Planus ◽

Large Scale ◽

Meta Analysis ◽

Fixed Effect Model ◽

Healthcare Research ◽

Oral Lichen

Abstract Background : To evaluate whether oral lichen planus (OLP) is a risk factor for peri-implant diseases (PIDs) with a systematic review and meta-analysis. Methods : Six electronic databases including Medline, Web of Science, etc. were searched. Included studies are observational human studies written in English. Population of interest were those with/without OLP who received dental implant treatment. Follow-up time after implantation is from one month to 20 years. The quality of the included literature regarding risk of bias and methodology was assessed with Newcastle-Ottawa Scale or the Agency for Healthcare Research and Quality. The data involving exposure (OLP), primary outcomes (implants having PIDs) and secondary outcomes (probing depth/PD, bleeding on probing/BOP and bone loss/BL) and potential confounders were extracted. Heterogeneity was assessed by I² tests. Dichotomous data were expressed as risk ratio (RR) and 95% confidence interval (CI) which were calculated with a fixed effect model. Results : Of 139 literatures, two studies were enrolled and evaluated as high quality, which totally contained 68 participants receiving 222 (OLP vs. non-OLP, 112 vs. 110) implants with 12 to 120-month follow-up time. Proportions of implants with PIDs between OLP and non-OLP groups were as follows: 19.6% (22/112) vs. 22.7% (25/110) for PIM; 17.0% (19/112) vs. 10.9% (12/110) for PI. Meta-analysis found no recognizable difference in number of implants with PIDs (PI: RR = 1.49, 95% CI 0.77-2.90, P = 0.24; PIM:RR = 0.88, 95% CI 0.53 -1.46, P = 0.61; PIDs: RR = 1.08, 95% CI 0.75 -1.55, P = 0.68) or BOP (RR = 0.90, 95% CI: 0.70-1.15, P = 0.40) between OLP and non-OLP groups. Conclusions : Available literature regarding the effects of OLP on PIDs remains very limited. Existing evidence seems not support OLP as a suspected risk factor for PIDs. Large-scale prospective trials are required to test the findings. Keywords : dental implants; peri-implant diseases; oral lichen planus; systematic review; meta-analysis.

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Is oral lichen planus a risk factor for peri-implant diseases? A systematic review and meta-analysis

10.21203/rs.3.rs-15960/v3 ◽

2020 ◽

Author(s):

Xiaoqin Xiong ◽

Tiantian Xu ◽

Xinhong Wang ◽

Wenguang Qin ◽

Ting Yu ◽

...

Keyword(s):

Systematic Review ◽

Risk Factor ◽

Lichen Planus ◽

Oral Lichen Planus ◽

Large Scale ◽

Meta Analysis ◽

Healthcare Research ◽

Cochrane Library ◽

Oral Lichen

Abstract Background : To evaluate whether oral lichen planus (OLP) is a risk factor for peri-implant diseases (PIDs) with a systematic review and meta-analysis. Methods : Five electronic databases including Medline, Embase, Web of Science, the Cochrane Library and Scopus were searched. The included studies are observational human studies written in English. The population of interest included those with/without OLP who received dental implant treatment. The follow-up time after implantation was from one month to 20 years. The quality of the included articles regarding risk of bias and methodology were assessed with the Newcastle-Ottawa Scale or the Agency for Healthcare Research and Quality. The data involving exposure (OLP), primary outcomes (implants having PIDs) and secondary outcomes (probing depth/PD, bleeding on probing/BOP and bone loss/BL) and potential confounders were extracted. Heterogeneity was assessed by I² test. Dichotomous data are expressed as the risk ratio (RR) and 95% confidence interval (CI) which were calculated with a fixed effect model. Results : Of the 66 articles, two studies were enrolled and evaluated as high quality, which totally contained 68 participants receiving 222 (OLP vs. non-OLP, 112 vs. 110) implants with 12 to 120-month follow-up time. Proportions of implants with PIDs between OLP and non-OLP groups were as follows: 19.6% (22/112) vs. 22.7% (25/110) for PIM and 17.0% (19/112) vs. 10.9% (12/110) for PI. The meta-analysis revealed no recognizable difference in number of implants with PIDs (PI: RR = 1.49, 95% CI 0.77-2.90, P = 0.24; PIM:RR = 0.88, 95% CI 0.53 -1.46, P = 0.61; PIDs: RR = 1.08, 95% CI 0.75 -1.55, P = 0.68) or BOP (RR = 0.90, 95% CI: 0.70-1.15, P = 0.40) between OLP and non-OLP groups. Conclusions : Available articles regarding the effects of OLP on PIDs remains very limited. Existing evidence does not support OLP as a suspected risk factor for PIDs. Large-scale prospective trials are required to validate the findings.

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Long-Term Prognosis of Endodontic Microsurgery—A Systematic Review and Meta-Analysis

Medicina ◽

10.3390/medicina56090447 ◽

2020 ◽

Vol 56 (9) ◽

pp. 447

Author(s):

Diogo Pinto ◽

Andréa Marques ◽

Joana F. Pereira ◽

Paulo J. Palma ◽

João Miguel Santos

Keyword(s):

Systematic Review ◽

Success Rate ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Filling Material ◽

Term Outcome ◽

Long Term Outcome ◽

Endodontic Microsurgery

Background and objectives: The long-term outcome of endodontic microsurgery (EMS) performed on root-filled teeth affected by post-treatment apical periodontitis (AP) has been a matter of debate, re-launched by the introduction of novel root-end filling materials which have been proven to improve the short-term outcome of EMS. The purpose of this systematic review and meta-analysis is to evaluate the clinical and radiographic long-term outcome of endodontic microsurgery in teeth diagnosed with secondary AP through radiographic evaluation. Materials and Methods: This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion and exclusion criteria were defined a priori to select the best longitudinal evidence. Only randomized clinical trials (RCT) and prospective clinical studies (PCS), with a follow-up ≥ 2-year, and exhibiting well-established clinical and radiographic outcome criteria, were selected. Results: A total of 573 articles were obtained, from which 10 fulfill inclusion criteria: 6 PCS and 4 RCT. Meta-analysis showed a pooled proportion of success rate of 91.3%, from an overall amount of 453 treated teeth included in RCT; from overall 839 included teeth in PCS, a pooled success rate of 78.4% was observed, with the follow-up time ranging from 2 to 13-years. Survival rate outcomes varied from 79 to 100% for the same follow-up period. Five prognostic factors with influence on the outcome were disclosed: smoking habits, tooth location and type, absence/presence of dentinal defects, interproximal bone level, and root-end filling material. Conclusions: High success rates and predictable results can be expected when EMS is performed by trained endodontists, allowing good prognosis and preservation of teeth affected by secondary AP.

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Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis

Endoscopy ◽

10.1055/a-0994-4361 ◽

2019 ◽

Vol 51 (10) ◽

pp. 941-949 ◽

Cited By ~ 3

Author(s):

Viveksandeep Thoguluva Chandrasekar ◽

Madhav Desai ◽

Muhammad Aziz ◽

Harsh K. Patel ◽

Venkata Subhash Gorrepati ◽

...

Keyword(s):

Systematic Review ◽

Large Scale ◽

Clinical Success ◽

Meta Analysis ◽

Clinical Success Rate ◽

Line Treatment ◽

Gi Bleeding ◽

Technical Success ◽

Primary Hemostasis

Background The over-the-scope clip (OTSC) has been increasingly utilized for the management of gastrointestinal (GI) bleeding. Limited efficacy data are currently available from large-scale studies. Methods An electronic database search was conducted for eligible articles using OTSCs for hemostasis in GI bleeding. The primary outcome was the rate of definitive hemostasis after primary hemostasis and without rebleeding at follow-up. Secondary outcomes were: primary technical success, primary clinical success, rebleeding, and failure rates. Pooled rates were expressed as proportions of patients with events over total patients, 95 % confidence limits (CI) with heterogeneity, and P values of < 0.05 for significance. Results A total of 21 studies (n = 851) were analyzed (62.2 % males), with a median patient age of 69.7 years. The definitive hemostasis rate was 87.8 % (95 %CI 83.7 % – 92 %) after a median follow-up of 56 days. The OTSC was successfully deployed in 97.8 % of patients (95 %CI 96.7 % – 98.9 %) and the primary clinical success rate was 96.6 % (95 %CI 95.1 % – 98.2 %). Rebleeding was seen in 10.3 % of patients (95 %CI 6.5 % – 14.1 %). The failure rate of OTSCs was 9 % (95 %CI 5.2 % – 12.8 %) when used as first-line treatment and 26 % (95 %CI 16.1 % – 36.0 %) when used as second-line treatment. Conclusion This systematic review showed high rates of definitive hemostasis, technical success, and clinical success, along with low rebleeding rates when OTSCs were used for the treatment of GI bleeding. The lack of randomized controlled trials of OTSC vs. other therapies makes comparison with conventional treatment difficult.

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Acupuncture for Recurrent Headaches: A Systematic Review of Randomized Controlled Trials

Cephalalgia ◽

10.1046/j.1468-2982.1999.1909779.x ◽

1999 ◽

Vol 19 (9) ◽

pp. 779-786 ◽

Cited By ~ 144

Author(s):

D Melchart ◽

K Linde ◽

P Fischer ◽

A White ◽

G Allais ◽

...

Keyword(s):

Systematic Review ◽

Rate Ratio ◽

Large Scale ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Real Life ◽

Outcome Data ◽

Responder Rate ◽

Control Group ◽

Controlled Trials

Objective: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Design: Systematic review. Study selection: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Data sources: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Data collection and analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Results: Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Conclusions: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.

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Systemic Antibiotic Prophylaxis to Reduce Early Implant Failure: A Systematic Review and Meta-Analysis

Antibiotics ◽

10.3390/antibiotics10060698 ◽

2021 ◽

Vol 10 (6) ◽

pp. 698

Author(s):

Elisabet Roca-Millan ◽

Albert Estrugo-Devesa ◽

Alexandra Merlos ◽

Enric Jané-Salas ◽

Teresa Vinuesa ◽

...

Keyword(s):

Systematic Review ◽

Antibiotic Prophylaxis ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Implant Failure ◽

Electronic Search ◽

Preoperative Antibiotic Prophylaxis ◽

Systemic Antibiotics ◽

Systemic Antibiotic Prophylaxis

Systemic antibiotics are routinely prescribed in implant procedures, but the lack of consensus causes large differences between clinicians regarding antibiotic prophylaxis regimens. The objectives of this systematic review are to assess the need to prescribe antibiotics to prevent early implant failure and find the most appropriate antibiotic prophylaxis regimen. The electronic search was conducted in PubMed/MEDLINE, Scielo and Cochrane Central Trials Database for randomized clinical trials of at least 3 months of follow-up. Eleven studies were included in the qualitative analysis. Antibiotics were found to statistically significantly reduce early implant failures (RR = 0.30, 95% CI: 0.19–0.47, p < 0.00001; heterogeneity I2 = 0%, p = 0.54). No differences were seen between preoperative or both pre- and postoperative antibiotic regimens (RR = 0.57, 95% CI: 0.21–1.55, p = 0.27; heterogeneity I2 = 0%, p = 0.37). A single preoperative antibiotic prophylaxis dose was found to be enough to significantly reduce early implant failures compared to no antibiotic (RR = 0.34, 95% CI: 0.21–0.53, p < 0.00001; heterogeneity I2 = 0%, p = 0.61). In conclusion, in healthy patients a single antibiotic prophylaxis dose is indicated to prevent early implant failure.

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The safety, tolerability and mortality reduction efficacy of remdesivir; based on randomized clinical trials, observational and case studies reported safety outcomes: an updated systematic review and meta-analysis

Therapeutic Advances in Drug Safety ◽

10.1177/20420986211042517 ◽

2021 ◽

Vol 12 ◽

pp. 204209862110425

Author(s):

Chenchula Santenna ◽

Kota Vidyasagar ◽

Krishna Chaitanya Amarneni ◽

Sai Nikhila Ghanta ◽

Balakrishnan Sadasivam ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Antiviral Drug ◽

Mortality Reduction ◽

Serious Adverse Events ◽

Significant Difference ◽

Grade 3

Introduction: Remdesivir, an experimental antiviral drug has shown to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), both in vitro and in vivo. The present systematic review and meta-analysis were performed to quantify the safety and tolerability of remdesivir, based on safety outcome findings from randomized controlled trials, observational studies and case reports of remdesivir in coronavirus disease 2019 (COVID-19) patients. Methods: We have performed a systematic search in the PubMed, Google Scholar and Cochrane Library using specific keywords such as ‘COVID-19’ OR ‘SARS CoV-2’ AND ‘Remdesivir’. The study endpoints include total adverse events (AEs), serious adverse events (SAEs), grade 3 and grade 4 AEs, mortality and drug tolerability. Statistical analysis was carried out by using Revman 5.4 software. Results: Total 15 studies were included for systematic review, but only 5 randomized clinical trials (RCTs) ( n = 13,622) were included for meta-analysis. Visual inspection of the forest plots for remdesivir 10-day versus placebo and remdesivir 10-day versus 5-day groups revealed that there is a significant difference in SAEs [10-day remdesivir versus control (odds ratio [OR] = 0.55, 0.40–0.74) p = 0.0001; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 0.56, 0.38–0.84) p = 0.005; I2 = 13%]. In grade 4 AEs, there is a significant difference in 10-day remdesivir versus control (OR = 0.32, 0.19–0.54) p = 0.0001; I2 = 0%, but not in comparison to 5-day remdesivir (OR = 0.95, 0.59–1.54) p = 0.85; I2 = 0%. But there is no significant difference in grade 3 AEs [remdesivir 10 day versus control (OR = 0.81, 0.59–1.11) p = 0.19; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.24, 0.86–1.80) p = 0.25; I2 = 0%], in total AEs [remdesivir 10 day versus control (OR = 1.07, 0.66–1.75) p = 0.77; I2 = 79%; remdesivir 10 day versus 5 day (OR = 1.08, 0.70–1.68) p = 0.73; I2 = 54%)], in mortality [10-day remdesivir versus control (OR = 0.93, 0.80–1.08) p = 0.32; I2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.39, 0.73–2.62) p = 0.32; I2 = 0%)] and tolerability [remdesivir 10 day versus control (OR = 1.05, 0.51–2.18) p = 0.89; I2 = 65%, 10-day remdesivir versus 5-day remdesivir (OR = 0.86, 0.18–4.01) p = 0.85; I2 = 78%]. Discussion & Conclusion: Ten-day remdesivir was a safe antiviral agent but not tolerable over control in the hospitalized COVID-19 patients with a need of administration cautiousness for grade 3 AEs. There was no added benefit of 10- or 5-day remdesivir in reducing mortality over placebo. To avoid SAEs, we suggest for prior monitoring of liver function tests (LFT), renal function tests (RFT), complete blood count (CBC) and serum electrolytes for those with preexisting hepatic and renal impairments and patients receiving concomitant hepatotoxic or nephrotoxic drugs. Furthermore, a number of RCTs of remdesivir in COVID-19 patients are suggested. Plain Language Summary Ten-day remdesivir is a safe antiviral drug with common adverse events in comparison to placebo. The rate of serious adverse events and grade 3 adverse events were significantly lower in 10-day remdesivir in comparison to placebo/5-day remdesivir. There was no significant difference in the rate of tolerability and mortality reduction in 10-day remdesivir over placebo/5-day remdesivir. There were no new safety signals reported in vulnerable populations, paediatric, pregnant and lactating women.

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