Table 3.

Studies with Severe Methodological Issues Evaluating HCQ for COVID-19 Treatment.

Study Design Pts Study Groups Results: Primary/Secondary* Outcomes Methodological Issues
Comparative multinational registry analysis29 96,032 1. CQ
2. CQ+macrolide
3. HCQ
4. HCQ+macrolide
5. SOC
Primary Outcome
  • Significant ↑ of in-hospital mortality rates for CQ (16.4%); CQ+macrolide (22.2%); HCQ (18.0%); HCQ+macrolide (23.8%); vs SOC (9.3%)
Secondary Outcome
  • All Tx groups independently associated with ↑ risk of de novo ventricular arrhythmia during hospitalization
  • Publication retracted as per request of three co-authors
  • The corporation that initially provided the Pt dataset refused to transfer the full dataset, client contracts, and ISO audit reports for re-analysis
Comparative observational study26 42 1. HCQ
2. SOC
Sig.Dif. in virological cure rates between HCQ (70%) and SOC (12.5%) groups (P=0.001)
  • Selection bias: SOC group comprised Pts who refused HCQ Tx
  • Failure to follow-up Pts for adequate post-treatment periods
  • Age difference between HCQ and SOC groups: mean age 51.2 years vs 37.3 years, respectively (P=0.06)
  • Unclear exclusion criteria for HCQ group
  • 5 SOC Pts with no virological test on day 6 were included in the final analysis as COVID-19-positive cases
Re-analysis of study,26 including the missing datasets27 42 1. HCQ
2. SOC
No significant differences in virological cure rates on treatment days 3, 4, 5, or 6* None. Study refers to methodological problems of the abovementioned study
Uncontrolled observational study28 aimed at replicating the above comparative observational study26 11 1. HCQ 20% of patients were virologically cured at day 5–6 post-inclusion*
*Only primary outcomes are shown, unless the study also provided secondary outcomes.

↑, increased/higher; CQ, chloroquine; ISO, International Organization for Standardization; HCQ, hydroxychloroquine; Pt(s), patient(s); RT-qPCR, reverse transcription polymerase chain reaction; Sig.Dif., significant difference(s); SOC, standard of care; Tx, treatment.

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2020 July; 11(3): e0025. ISSN: 2076-9172
Published online 2020 July 31. doi: 10.5041/RMMJ.10416.