Treatment success of Dr. Vladimir (Zev) Zelenko

I’m sure many of you heard of this family practice physician in New York state who has reported 100% success in treating COVID-19 patients using a drug “cocktail”.

I just want to clarify that his reports, while helpful, do not represent any rigorous clinical evidence for a COVID-19 treatment. Based on his open letter, it appears that he has treated roughly 130 patients according to his algorithm, some of whom received the drug “cocktail”.

His algorithm was to treat anyone with concerning symptoms, particularly if at high risk for developing severe disease, with hydroxychloroquine, azithromycin, and zinc.

This report has no control group (to compare results from a treatment group against) and was not randomized. We can only take his results as hope that his results can be reproduced elsewhere.

I have copied my review of the study from France that described a similar drug cocktail and its effect in a case-control study. The bottom line: only preliminary and anecdotal evidence for benefit from hydroxychloroquine and azithromycin.

So let’s stay hopeful that these results can be replicated so we can safely treat patients with evidence-based medications!

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More details on that study from France:

  • Design: non-randomized; controls were patients from a different center refusing the proposed treatment protocol
  • N = 20 patients with adequate follow-up (treatment group), hospitalized with confirmed COVID-19 by PCR (age > 12yr)
    • Exclusion criteria: retinopathy, G6PD deficiency, QT prolongation, breastfeeding, pregnancy
    • Note: 6 patients lost to follow-up in treatment group (26 originally), reasons included: death, ICU transfer, discontinuation from side effects (nausea)
    • “Control group” (untreated) n = 16
    • Even though some patients were asymptomatic (16%), all patients had pneumonia (on CT)
    • Mean age 45 years
  • End point: viral presence (nasopharyngeal swab) at day 6 of treatment
  • Result: virological “cure” at day 6 (p = 0.001):
    • Hydroxychloroquine group: 70%
    • Control group: 12.5% in the control group
  • Subgroup analysis of the hydroxychloroquine group showed virological “cure” at day 6 (“severe cases” were given azithromycin):
    • Hydroxychloroquine plus azithromycin combination: 100%
      • Notably significant reduction in viral load by day 3
    • Hydroxychloroquine alone: 57.1%
  • Interestingly, two of the hydroxychloroquine failures were seen in a mother and son (suggesting a pattern of resistance in the viral strain or host metabolism)
  • Limitations: non-randomized, open-label, small sample size, limited long-term outcome follow-up, significant dropout, unclear what the criteria was used for addition of azithromycin

References: https://docs.google.com/document/d/1SesxgaPnpT6OfCYuaFSwXzDK4cDKMbivoALprcVFj48/preview Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of  COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of  Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949 

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