Geleris et al., NEJM, May 7, 2020,
doi:10.1056/NEJMoa2012410 (Peer Reviewed)
Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19
There appears to be a major error in this paper. Before propensity matching, 38 control patients had hypertension. After propensity matching, 146 patients had hypertension (Table 1). This is not possible. Even if all propensity matched control patients had hypertension, the control prevalence would only be 14% compared to 49% for treatment. Since patients with hypertension are at much greater risk of mortality (HR 2.12, see [1]), this appears to invalidate the results.
Observational study of 1,446 hospitalized patients showing no significant effect on a combined intubation/death outcome for late treatment.
However, secondary analysis shows the success of HCQ was hidden by combining intubation and death - death / (combined death/intubation) for HCQ was 60% vs. control 89%, for details see: [2].
RCT recommended. No AZ or Zinc. HCQ group much sicker - patients already in mild/moderate ARDS, most of the control group not in ARDS. Control cases received other therapeutics.
Geleris et al., 5/7/2020, retrospective, USA, North America, peer-reviewed, 12 authors.
risk of combined intubation/death, 4.0% higher, RR 1.04, p = 0.76, treatment 262 of 811 (32.3%), control 84 of 565 (14.9%), adjusted per study.
This study is excluded in meta analysis: significant issues found with adjustments.
Effect extraction follows
pre-specified rules
prioritizing more serious outcomes. For an individual study the most serious
outcome may have a smaller number of events and lower statistical signficance,
however this provides the strongest evidence for the most serious outcomes
when combining the results of many trials.