scholarly journals Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Cathrine Axfors ◽  
Perrine Janiaud ◽  
Andreas M. Schmitt ◽  
Janneke van’t Hooft ◽  
Emily R. Smith ◽  
...  

Abstract Background Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Ramy Mando ◽  
Akshay Goel ◽  
Fuad Habash ◽  
Marwan Saad ◽  
Karam Ayoub ◽  
...  

Background. Cardiac contractility modulation (CCM) is a device therapy for systolic heart failure (HF) in patients with narrow QRS. We aimed to perform an updated meta-analysis of the randomized clinical trials (RCTs) to assess the efficacy and safety of CCM therapy. Methods. We conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) between January 2001 and June 2018. Outcomes of interest were peak oxygen consumption (peak VO2), 6-Minute Walk Distance (6MWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ), HF hospitalizations, cardiac arrhythmias, pacemaker/ICD malfunctioning, all-cause hospitalizations, and mortality. Data were expressed as standardized mean difference (SMD) or odds ratio (OR). Results. Four RCTs including 801 patients (CCM n = 394) were available for analysis. The mean age was 59.63 ± 0.84 years, mean ejection fraction was 29.14 ± 1.22%, and mean QRS duration was 106.23 ± 1.65 msec. Mean follow-up duration was six months. CCM was associated with improved MLWHFQ (SMD -0.69, p = 0.0008). There were no differences in HF hospitalizations (OR 0.76, p = 0.12), 6MWD (SMD 0.67, p = 0.10), arrhythmias (OR 1.40, p = 0.14), pacemaker/ICD malfunction/sensing defect (OR 2.23, p = 0.06), all-cause hospitalizations (OR 0.73, p = 0.33), or all-cause mortality (OR 1.04, p = 0.92) between the CCM and non-CCM groups. Conclusions. Short-term treatment with CCM may improve MLFHQ without significant difference in 6MWD, arrhythmic events, HF hospitalizations, all-cause hospitalizations, and all-cause mortality. There is a trend towards increased pacemaker/ICD device malfunction. Larger RCTs might be needed to determine if the CCM therapy will be beneficial with longer follow-up.


2021 ◽  
Author(s):  
Mohammad Ali Omrani ◽  
Amin Salehi-Abargouei ◽  
Behrooz Heydari ◽  
Nazgol Kermanshahi ◽  
Fatemeh Joukar ◽  
...  

Abstract BackgroundThis systematic review and meta-analysis aimed to assess the efficacy of the Ivermectin/Doxycycline combination for the treatment of coronavirus disease 2019 (COVID-19).MethodsWe searched PubMed, Web of Science, Scopus, ClinicalTrials.gov, and Google Scholar from database inception to August 26, 2021 for relevant studies. We included studies reporting at least one of the outcomes of interest: all-cause mortality; time to clinical recovery; hospital stay and viral clearance. The logarithm of risk ratios or mean differences and their corresponding standard errors for each outcome were pooled using a random-effects model. The risk of bias was assessed using the Cochrane Collaboration's tool for randomized clinical trials and the Newcastle-Ottawa Scale for cohort studies.ResultsFour randomized clinical trials and one prospective study involving 789 patients, including 399 in the Ivermectin/Doxycycline group and 390 in the control group, were enrolled. The all-cause mortality rate of patients with COVID-19 in the Ivermectin/Doxycycline group was 0.79% (2/253), which was lower than in the control group (3.6%; 9/250). However, the difference was not statistically significant (Log risk ratio=-1.288; 95% CI:-2.671, 0.096; P = 0.068; I2 = 0%). The effect of Ivermectin/Doxycycline on time to clinical recovery was found to be significant (Difference in means =-2.427 days; 95% CI:-4.033, -0.820; P = 0.003, I2 = 91.475%). There is no significant effect of Ivermectin/Doxycycline on hospital stay (Difference in means =-0.379 days; 95% CI:-1.965, 1.208; P = 0.640, I2 = 91.95%) and time to negative PCR or viral clearance (Difference in means =-0.768 days; 95% CI:-1.550, 0.013; P = 0.054, I2 = 91.48%).DiscussionBased on low-quality evidence, this meta-analysis showed that Ivermectin/Doxycycline combination is accompanied with shorter time of clinical recovery in COVID-19 patients. However, it did not reduce all-cause mortality, viral clearance, and hospital stay significantly. Not only the number of the studies are limited but also they ranked methodologically medium to low with limited participants. To assess the exact effective dose and efficacy of this combination therapy, high-quality and large-scale randomized clinical trials are needed.OtherThis study was registered in Prospero (registration number: CRD42021272400). The authors declare they have no competing financial interests.


Author(s):  
Reagan F. Cabahug ◽  
Gina L. Montalan ◽  
Irma P. Yape ◽  
Maria Christina M. Laurenciana

Objective: To update Sagar et.al. systematic review and meta-analysis on exercise-based rehabilitation for heart failure. Methods: A systematic review and meta-analysis of randomized clinical trials on exercised-based cardiac rehabilitation. MEDLINE, OVID and cross references were searched for RCTs published between February 2013 up to August 2018. Trials with at least 6 months follow up were included if exercise training program alone or as a component of comprehensive cardiac rehabilitation was compared with groups without exercise prescription. Results: A total of 11,989 patients were included in the 43 randomized clinical trials predominantly with reduced EF and NYHA class ll -lll. Exercise training program prescription in heart failure patients reduced the all-cause mortality (RR=0.76; 95%CI= 0.66, 0.87; P= 0.001), all cause hospitalization after 12 months (RR=0.70; 95% CI= 0.52, 0.96; P= 0.02) rehospitalization due to heart failure (RR= 0.49; 95% CI= 0.44, 0.55; P= <0.0001) and improvement in quality-of-life scores (RR= -0.36; 95% CI= -0.58, -0.14; P= 0.002). Among these health quality related outcomes, the all-cause mortality and the hospitalization admission after 12 months follow up showed a significant association with exercise therapy program, particularly on exercise setting(p=0.026) and exercise dose (p=0.013), respectively, as revealed by the univariate meta-regression results. Conclusion: This study has shown that exercise therapy either in center or home based has benefited heart failure patients in reducing the risk of all-cause mortality up to 12 months, hospital admission up 12 months, and has given a better quality of life. The new studies included have further strengthened the findings of previous studies that an exercise therapy program provides benefit to heart failure patients, either as an “alone” intervention or together with a cardiac rehabilitation program; and that the setting and dose of an exercise therapy program provide significant contribution to a reduced risk in all-cause mortality and hospitalization after 12 months follow up, respectively.


2019 ◽  
Vol 15 (4) ◽  
pp. 232-237
Author(s):  
Mir Hadi Musavi ◽  
Behzad Jodeiri ◽  
Keyvan Mirnia ◽  
Morteza Ghojazadeh ◽  
Zeinab Nikniaz

Background: Although, some clinical trials investigated the maternal and neonatal effect of fentanyl as a premedication before induction of general anesthesia in cesarean section, to the best of our knowledge, there is no systematic review to summarize these results. Objectives: The present systematic review and meta-analysis evaluated the maternal and neonatal effect of intravenous fentanyl as a premedication before induction of general anesthesia in cesarean section. Methods: The databases of Pubmed, Embase, Scopus and Cochrane library were searched till July 2017 to identify randomized clinical trials which evaluated the effects of intravenous fentanyl as a premedication before induction of general anesthesia compared with placebo on neonate first and fifth minute Apgar score and maternal heart rate and mean arterial pressure (MAP) in cesarean section. Standard Mean difference (SMD) was calculated and I-square statistic test was used for heterogeneity analysis. Results: The present systematic review and meta-analysis consisted of three clinical trials including 180 women in labor. Considering the results of meta-analysis, there is no significant differences between fentanyl and placebo in the case of Apgar score at 1 minute; however, the Apgar score of 5 minutes was significantly lower in fentanyl group compared with placebo (SMD -0.68, 95%CI: - 0.98, -0.38, p<0.001). In the term of maternal hemodynamics, the heart rate (SMD -0.43, 95%CI: - 0.72, -0.13, p=0.004) and MAP (SMD -0.78, 95% CI: -1.09, -0.48, p<0.001) in fentanyl group were significantly lower compared with placebo group. Conclusion: The present meta-analysis showed that using intravenous fentanyl as a premedication before induction of general anesthesia had adverse effects on neonate Apgar score. However, it had positive effects on preventing adverse consequences of intubation on maternal hemodynamics.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pooya Ebrahimi ◽  
Mahdi Hadilou ◽  
Ferdos Naserneysari ◽  
Amirmohammad Dolatabadi ◽  
Rana Tarzemany ◽  
...  

Abstract Background Photobiomodulation is widely being used to improve the wound healing process in dentistry and a vast majority of studies have proven its benefits. But there are plenty of knowledge gaps according to the optimal laser characteristics which should be used to maximize the healing effects of lasers. The goal of this systematic review and meta-analysis was to determine the effect of photobiomodulation (PBM) as an adjunctive treatment to periodontal therapies to evaluate secondary intention gingival wound healing and post-operative pain. Methods Five databases (PubMed, Embase, Scopus, ProQuest, and Web of Sciences) were searched up to November 30, 2020, for clinical trials that reported the result of the application of PBM on secondary gingival healing wounds and post-operative pain and discomfort after periodontal surgeries. Two independent reviewers selected the eligible studies and the outcomes of interest were extracted. The quality of eligible studies was assessed using the Cochrane Handbook for Systematic Reviews of Interventions. Results Ultimately, twelve studies were included in this review. The application of PBM as an adjunct to periodontal surgeries resulted in a significant improvement in wound healing indices. The Landry wound healing index at the 7th post-operative day was significantly improved (SMD = 1.044 [95% CI 0.62–1.46]; p < 0.01) in PBM + surgery groups compared to the control groups. There was also a statistically significant increase in the complete wound epithelialization (RR = 3.23 [95% CI 1.66–6.31]; p < 0.01) at the 14th post-operative day compared to the control groups. The methods used to assess the post-operative pain were heterogeneous, and therefore the results were limited which made the meta-analysis for post-operative pain assessment not possible. Conclusion Based on the results of this review, PBM can be effectively used as a method to improve secondary intention wound healing. High-quality randomized clinical trials, however, are needed in the future to identify the optimal PBM irradiation parameters and the effect of PBM on post-operative pain.


Author(s):  
Fatemeh Hajizadeh-Sharafabad ◽  
Elham Sharifi Zahabi ◽  
Mahsa Malekahmadi ◽  
Rasoul Zarrin ◽  
Mohammad Alizadeh

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