scholarly journals Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results

2020 ◽  
Vol 3 (8) ◽  
pp. e2012469
Author(s):  
Muhammad Shahzeb Khan ◽  
Gregg C. Fonarow ◽  
Tim Friede ◽  
Noman Lateef ◽  
Safi U. Khan ◽  
...  
Author(s):  
Ville N. Pimenoff ◽  
Miriam Elfström ◽  
Joakim Dillner

ABSTRACTBackgroundTransfusion of convalescent immune plasma (CP) is commonly used in epidemics. Several articles now describe clinical report data of CP for treatment of SARS-CoV-2-induced COVID-19 disease.MethodsA systematic literature review was conducted using the NCBI curated COVID-19 related open-resource literature database LitCovid to identify studies using CP as treatment for COVID-19 patients. We retrieved and curated all COVID-19 related patient and treatment characteristics from previously reported studies. A Poisson model was developed to evaluate the association between age of the patients, older age being the most common risk factor for COVID-19 mortality, and recovery time since CP treatment using data extracted from the literature.ResultsFrom 18,293 identified COVID-19 related articles, we included ten studies reporting results of CP treatment for COVID-19 from a total of 61 patients. Decreased symptoms of severe COVID-19 and clearance of SARS-CoV-2 RNA were the most direct observations. We found that patients over the age of sixty who received CP treatment for COVID-19 had a significantly prolonged recovery estimated by viral clearance (from 10 to 29 days since first dose of CP) compared to younger patients, who recovered from the infection in less than a week after receiving CP treatment.ConclusionsLimited published results on plasma transfusion treatment for COVID-19 disease with concomitant treatments suggest that CP therapy for COVID-19 is well tolerated and effective. First randomized clinical trial results, however, revealed no improvements in recovery time for elderly patients with severe COVID-19 between standard treatment alone and added with convalescent plasma. Accordingly, we argue that older patients may need a significantly longer time for recovery. Further randomized clinical trial data for COVID-19 with rigorous ethical standards is urgently needed.


2021 ◽  
Vol 11 ◽  
pp. 239-251
Author(s):  
Carl L. Herndon ◽  
Kyle L. McCormick ◽  
Anastasia Gazgalis ◽  
Elise C. Bixby ◽  
Matthew M. Levitsky ◽  
...  

2018 ◽  
Vol 188 (2) ◽  
pp. 426-437 ◽  
Author(s):  
Jin-Liern Hong ◽  
Michael Webster-Clark ◽  
Michele Jonsson Funk ◽  
Til Stürmer ◽  
Sara E Dempster ◽  
...  

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