Did it work? First randomized clinical trial of hydroxychloroquine in treating COVID-19

hydroxychloroquine as a treatment for COVID-19

We need to discuss the latest updates in COVID-19 treatment options given the “pre-release” results of a hydroxychloroquine intervention from a randomized clinical trial in Wuhan, China (not peer-reviewed). Note that this represents the “gold standard” evidence for medical interventions.

I reviewed the first study outside of China using hydroxychloroquine in a previous post – see here (note that it was not a randomized trial)

While I have provided a breakdown of the study below, the take-home for readers is as follows:

There are key differences in China’s “standard of care” treatment for COVID-19 compared to the United States, specifically using multiple medications that have not been validated. This trial controls for them and only investigated hydroxychloroquine. Though the results have not been peer reviewed yet. They do show faster resolution of fever, cough, and pneumonia with the use of hydroxychloroquine.

There are several additional notable findings: this study used a different treatment regimen than that studied in France (lower dose of hydroxychloroquine, for less time, and without the addition of azithromycin). It also did not use zinc, as the family medicine physician in New York State used in his protocol. Also, only roughly 60% of patients at the start of the trial had fever or cough, emphasizing how unreliable symptoms are at predicting COVID-19. Lastly, the effect sizes (meaning how drastic the effect of hydroxychloroquine was) were appreciable, but not overwhelming. Reassuringly, there were few side effects (and none severe) in the hydroxychloroquine group.

Take home: this study supports the safety of hydroxychloroquine (with respect to side effects) and supports the further investigation of hydroxychloroquine in larger studies with more patients. This study also used a very different hydroxychloroquine protocol than other protocols described in the literature.

Unfortunately no miracle cure it yet, but let’s continue to be hopeful!

Breakdown of Wuhan randomized clinical trial on hydroxychloroquine in COVID-19:

  • Study type: randomized clinical trial
  • Population: N = 62 (Wuhan, China)
    • Age >18yr (mean 44yr), PCR positive SARS-CoV-2, chest CT positive for pneumonia, hypoxic on room air
    • Exclusion criteria: severe or critical illness, retinopathy, conduction block, arrhythmias, severe liver disease, pregnant or breast feeding, CKD (eGFR<30)
    • Note: at enrollment only 62% had fever and only 60% had cough
  • Intervention:
    • Control: Standard treatment: rec’d O2, antiviral Tx, Abx, immunoglobulin, +/- steroids
    • Hydroxychloroquine (HCQ) group: 400mg daily x5 days (note different dose than French study and without azithromycin)
  • Outcomes: Time to clinical remission (TTCR, including fever and cough improvement) and radiology @ baseline versus 5 days post treatment
    • Cough relief defined as 72+ hours of improvement
  • Results: pneumonia, body temp, and cough faster resolution in HCQ group
    • Fever resolution time 0.4 days shorter
    • Cough remission time not quantified in study, but reported as “statistically significant”
    • Pneumonia at 5 days improved in HCQ vs control (80.6% vs 54.8%)
    • All (total n=4) severely ill patients were notably in the control group
    • HCQ group had 2 patients with mild side effects (rash and headache)

Reference: https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v2.full.pdf

Success! You're on the list.

Leave a Reply