Changes

The French newspaper ''France Soir'' looked at the study's data and concluded HCQ had some benefit for individuals treated for COVID-19 1-2 days after exposure (at 90% confidence, which doesn't quite make it to p <.05). ''France Soir'' also reported that Dr. Boulware scheduled a presentation for October 5, 2019 where he disclosed having received a research grant from Gilead Sciences.<ref>[http://www.francesoir.fr/societe-sante/le-diable-est-vraiment-dans-le-detail-apres-lancet-nous-remettons-en-cause-le-new Le diable est VRAIMENT dans le détail, après The Lancet, nous remettons en cause le New England Journal of Medecine.] by The Citizens’ Collective for ''FranceSoir'' (May 4, 2020) ''FranceSoir''</ref>  Gilead is the maker of remdesivir.  To Boulware's credit, he recognizes the study's flaws.  According to Dr. Lewis, "He  also points out that day 1-3 use had statistical significance and he’s gearing his other studies accordingly. He intends to investigate this significance further."<ref>[https://c19study.com/boulware.html COVID-19 Treatment Analysis: Boulware et al. Comments] by CovidAnalysis (accessed July 31, 2020)</ref>  

The French newspaper ''France Soir'' looked at the study's data and concluded HCQ had some benefit for individuals treated for COVID-19 1-2 days after exposure (at 90% confidence, which doesn't quite make it to p <.05). ''France Soir'' also reported that Dr. Boulware scheduled a presentation for October 5, 2019 where he disclosed having received a research grant from Gilead Sciences.<ref>[http://www.francesoir.fr/societe-sante/le-diable-est-vraiment-dans-le-detail-apres-lancet-nous-remettons-en-cause-le-new Le diable est VRAIMENT dans le détail, après The Lancet, nous remettons en cause le New England Journal of Medecine.] by The Citizens’ Collective for ''FranceSoir'' (May 4, 2020) ''FranceSoir''</ref>  Gilead is the maker of remdesivir.  To Boulware's credit, he recognizes the study's flaws.  According to Dr. Lewis, "He  also points out that day 1-3 use had statistical significance and he’s gearing his other studies accordingly. He intends to investigate this significance further."<ref>[https://c19study.com/boulware.html COVID-19 Treatment Analysis: Boulware et al. Comments] by CovidAnalysis (accessed July 31, 2020)</ref>  

   

   

The University of Minnesota conducted another study entitled [https://pubmed.ncbi.nlm.nih.gov/32673060/ Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial]  with a similar trial design, with Boulware as a co-author.  Like its predecessor, it used internet surveys and overnight shipping of the drugs.  During the trial, a major problem occurred... "the low event rate of hospitalizations or deaths in the trial would have required increasing the sample size to 6000 participants" and they only had 491 participants.  Instead of making the study more robust by adding more participants, the study incorporated "overall symptom severity" instead of hospitalization as an endpoint.  While more people had PCR confirmed Covid-19 than the earlier study, only 58% of participants received SARS-CoV-2 testing.   

The University of Minnesota conducted another study entitled [https://pubmed.ncbi.nlm.nih.gov/32673060/ Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial]  with a similar trial design, with Boulware as a co-author.  Like its predecessor, it used internet surveys and overnight shipping of the drugs.  During the trial, a major problem occurred... "the low event rate of hospitalizations or deaths in the trial would have required increasing the sample size to 6000 participants" and they only had 491 participants.  Instead of making the study more robust by adding more participants, the study incorporated "overall symptom severity" instead of hospitalization as an endpoint.  While more people had PCR confirmed COVID-19 than the earlier study, only 58% of participants received SARS-CoV-2 testing.   

The study failed to reach statistical significance which should be unsurprising given its limitations. The results were positive, however, with HCQ having a P value of .21 for lower rate of ongoing symptoms and a P value of .29 for a lower rate of hospitalization.<ref>[https://pubmed.ncbi.nlm.nih.gov/32673060/ Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial] by Caleb P Skipper et. al. (2020 Jul 16) ''Annals of Internal Medicine''</ref>

The study failed to reach statistical significance which should be unsurprising given its limitations. The results were positive, however, with HCQ having a P value of .21 for lower rate of ongoing symptoms and a P value of .29 for a lower rate of hospitalization.<ref>[https://pubmed.ncbi.nlm.nih.gov/32673060/ Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial] by Caleb P Skipper et. al. (2020 Jul 16) ''Annals of Internal Medicine''</ref>