Literature DB >> 34460428

Response to "Randomized Controlled Trials on COVID-19 Should be Accurate and Trustworthy".

Sherief Abd-Elsalam, Shaimaa Soliman.   

Abstract

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Year:  2021        PMID: 34460428      PMCID: PMC8733512          DOI: 10.4269/ajtmh.21-0836b

Source DB:  PubMed          Journal:  Am J Trop Med Hyg        ISSN: 0002-9637            Impact factor:   3.707


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Dear Sir, We thank Ben W. Mol for his comments and questions, and appreciate the meticulous reading of our recently published article. We agree that randomized controlled trials on COVID-19 should be accurate and trustworthy. Regarding the first concern, our study started on March 23 and was finalized on June 1, 2020. Patients were monitored for 4 weeks. All data were available by July 1, and we worked to publish our report as quickly as possible to help address controversies regarding use of hydroxychloroquine for COVID-19. We are proud that our study was among the early studies that found that hydroxychloroquine has no benefit in the management of COVID-19., Regarding the second concern about conducting two trials during the same period,, we would like to clarify that we contributed to the multicenter study published in the Archives of Virology, but not the other referenced study. Regarding the third concern, updated information is provided in the clinical trial registry. Also, the sample size determination was provided in the Methods section, and a post hoc sample power analysis was included at the end of the Results section. Regarding the fourth concern, most variables were nonparametric, and P values were calculated with the Mann Whitney test; it is not clear how P values could be calculated without the data rank. Regarding the fifth concern, we included median values for some of the nonparametric variables, and this might have caused confusion. Regarding the last concern, the recovery rate is a categorical variable analyzed by the χ2 or Fisher exact test, whereas the other variables considered were continuous and analyzed using the t- or Mann Whitney tests. In our case, the P value for comparing disease severity between groups was 0.06, and all other P values were insignificant as well. We again thank Ben W. Mol for his great interest in our article.
  5 in total

1.  Randomized Controlled Trials on COVID-19 Should Be Accurate and Trustworthy.

Authors:  Ben W Mol
Journal:  Am J Trop Med Hyg       Date:  2021-08-30       Impact factor: 3.707

2.  Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study.

Authors:  Hany M Dabbous; Sherief Abd-Elsalam; Manal H El-Sayed; Ahmed F Sherief; Fatma F S Ebeid; Mohamed Samir Abd El Ghafar; Shaimaa Soliman; Mohamed Elbahnasawy; Rehab Badawi; Mohamed Awad Tageldin
Journal:  Arch Virol       Date:  2021-01-25       Impact factor: 2.574

3.  Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Authors:  Cathrine Axfors; Andreas M Schmitt; Perrine Janiaud; Janneke Van't Hooft; Sherief Abd-Elsalam; Ehab F Abdo; Benjamin S Abella; Javed Akram; Ravi K Amaravadi; Derek C Angus; Yaseen M Arabi; Shehnoor Azhar; Lindsey R Baden; Arthur W Baker; Leila Belkhir; Thomas Benfield; Marvin A H Berrevoets; Cheng-Pin Chen; Tsung-Chia Chen; Shu-Hsing Cheng; Chien-Yu Cheng; Wei-Sheng Chung; Yehuda Z Cohen; Lisa N Cowan; Olav Dalgard; Fernando F de Almeida E Val; Marcus V G de Lacerda; Gisely C de Melo; Lennie Derde; Vincent Dubee; Anissa Elfakir; Anthony C Gordon; Carmen M Hernandez-Cardenas; Thomas Hills; Andy I M Hoepelman; Yi-Wen Huang; Bruno Igau; Ronghua Jin; Felipe Jurado-Camacho; Khalid S Khan; Peter G Kremsner; Benno Kreuels; Cheng-Yu Kuo; Thuy Le; Yi-Chun Lin; Wu-Pu Lin; Tse-Hung Lin; Magnus Nakrem Lyngbakken; Colin McArthur; Bryan J McVerry; Patricia Meza-Meneses; Wuelton M Monteiro; Susan C Morpeth; Ahmad Mourad; Mark J Mulligan; Srinivas Murthy; Susanna Naggie; Shanti Narayanasamy; Alistair Nichol; Lewis A Novack; Sean M O'Brien; Nwora Lance Okeke; Léna Perez; Rogelio Perez-Padilla; Laurent Perrin; Arantxa Remigio-Luna; Norma E Rivera-Martinez; Frank W Rockhold; Sebastian Rodriguez-Llamazares; Robert Rolfe; Rossana Rosa; Helge Røsjø; Vanderson S Sampaio; Todd B Seto; Muhammad Shehzad; Shaimaa Soliman; Jason E Stout; Ireri Thirion-Romero; Andrea B Troxel; Ting-Yu Tseng; Nicholas A Turner; Robert J Ulrich; Stephen R Walsh; Steve A Webb; Jesper M Weehuizen; Maria Velinova; Hon-Lai Wong; Rebekah Wrenn; Fernando G Zampieri; Wu Zhong; David Moher; Steven N Goodman; John P A Ioannidis; Lars G Hemkens
Journal:  Nat Commun       Date:  2021-04-15       Impact factor: 14.919

4.  Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.

Authors:  Sherief Abd-Elsalam; Eslam Saber Esmail; Mai Khalaf; Ehab Fawzy Abdo; Mohammed A Medhat; Mohamed Samir Abd El Ghafar; Ossama Ashraf Ahmed; Shaimaa Soliman; Ghada N Serangawy; Mohamed Alboraie
Journal:  Am J Trop Med Hyg       Date:  2020-10       Impact factor: 3.707

5.  Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomised controlled trial.

Authors:  Hany M Dabbous; Manal H El-Sayed; Gihan El Assal; Hesham Elghazaly; Fatma F S Ebeid; Ahmed F Sherief; Maha Elgaafary; Ehab Fawzy; Sahar M Hassany; Ahmed R Riad; Mohamed A TagelDin
Journal:  Sci Rep       Date:  2021-03-31       Impact factor: 4.379

  5 in total

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