Results of a randomised, control trial using hydroxychloroquine drug in 150 COVID-19 patients show that the drug does not reduce the viral load even on day 28. Seventy-five patients got the drug and standard of care while the remaining got only standard of care. Patients were given 1,200 mg of the drug for three days followed by 800 mg daily for two and three weeks in patients with mild/moderate and severe symptoms, respectively.
First randomised trial
Researchers from the Shanghai Jiao Tong University School of Medicine, Shanghai, who led the team say that in contrast to other trials that have shown good results, the randomised trial did not show that hydroxychloroquine drug was able to suppress viral replication. This is the first trail using hydroxychloroquine where patients have been randomised to receive either the drug or just standard of care. However, patients who got the drug did show quicker alleviation of clinical symptoms, possibly through anti-inflammatory properties and improvement in white blood cell count. The drug did not cause any serious adverse effects in patients. But some patients did experience adverse effects.
The most common adverse event in patients who got the drug was diarrhoea (10%).
The results were posted in preprint server MedRxiv . Preprints are yet to be peer-reviewed and published in scientific journals.
Patients (mean age 46 years; 55% males) were enrolled at 16 government-designated coronavirus (COVID-19) treatment centres in three provinces — Hubei, Henan and Anhui — between February 11 and 29, 2020.
During the trial, specimens were taken from the upper and/or lower respiratory tract on the day of screening and during treatment and post-treatment follow-up.
The authors say that the dosage used in the trial was meant to reach the 50% effective concentrations of hydroxychloroquine against the virus. “It is not likely to have additional anti-viral effects by further escalating dosage,” they write.
In the case of COVID-19, systemic inflammation or cytokine storm is the driver of disease progression and death. Substantial reduction in white blood cell count and increase in inflammatory response have generally been observed in patients who have eventually progressed and died. The researchers observed “moderate increase” in while blood cell count and “significantly greater reduction” in the marker for inflammation. These effects were seen after fifth day of treatment and continued till the end of the treatment.
“These encouraging results suggest clinical benefits of adding hydroxychloroquine into the current standard management to limit inflammatory response, which is the key to prevent systemic inflammation and subsequent multiple organ failure and death,” they write. “The shorter time to alleviate the symptoms might be useful for preventing disease progression.”