Is Anti-Malarial ‘Game Changer?’—Not Yet because the Rigorous Clinical Trials Data is Lacking

Apr 4, 2020 | Anti-malarial drug, Chloroquine, Clinical Trials, Coronavirus, COVID-19, Hydroxychloroquine

Is Anti-Malarial ‘Game Changer?’—Not Yet because the Rigorous Clinical Trials Data is Lacking

Although the U.S. President called it a “game changer” and the U.S. Food and Drug Administration (FDA) approved the drug for emergency use authorization, the use of antimalarial drugs, hydroxychloroquine and related medication chloroquine, in emergency use for treatment of SARS-CoV-2 is questioned by many. In the meantime, there were runs on the drug in American markets and those that needed the drug for lupus, for example, couldn’t find any. A recent study published in a French medical journal offers evidence that hydroxychloroquine doesn’t help the immune system stop COVID-19. This follows a couple other studies (in China and France) that hydroxychloroquine combined with azithromycin may help patients with mild cases of COVID-19. Other small studies show mixed results. One large study sponsored by the University of Oxford alongside others in America may bring some clarity. Something needs to be done as the SARS-CoV-2 pandemic intensifies.

The Studies Not That Positive

One recent French study published in the Medicine et Maladies Infectieuses suggests that based on their findings that the antimalarial drug doesn’t help COVID-19 patients fight off the virus. The French team concluded that although in vitro found some antiviral activity, they found no evidence of strong antiviral activity or clinical benefit of the combination of hydroxychloroquine and azithromycin for the treatment of hospitalized patients with severe COVID-19. They posit that large ongoing randomized controlled trials, of the type organized by University of Oxford (and covered by TrialSite News), hopefully will drive sufficient data as to the true effectiveness of this therapy. This recent French study was led by Saint Louis Hospital, Infectious Disease Department, University of Paris, and INSERM

Recently, a Chinese-based study questions the claims of the antiviral drug’s effectiveness against COVID-19. In this study, the Shanghai Public Health Clinical Center was the site where 30 COVID-19 patients were given hydroxychloroquine. The group was randomized 1:1 to an experimental therapy group and a control group. Patients in the therapy group were given 400mg of hydroxychloroquine per day for five days plus conventional treatments, while those in the control group were given the conventional treatment only. The results show that one patient in the therapy group developed to a severe level during the treatment on day 7, and COVID-19 nucleic acid of throat swabs was negative in 13 (86.7%) cases in the therapy group and 14 (93.3%) cases in the control group. Median days of hospitalization was similar for both the therapy and control group. Moreover, the median time for body temperature normalization was similar for both groups. The study concluded that a larger sample size would be required to determine better endpoints.

And another study highlighted by TrialSite News showcased a Chinese study led by Renmin Hospital of Wuhan University (posted in medRvix) although not peer-reviewed, nonetheless is worth mentioning. 

In this study, the investigators acknowledged that chloroquine evidences antagonism against COVID-19 in vitro. But, the evidence for any claims that it works in humans against COVID-19 cannot be certain. Out of 62 patients admitted to Renmin Hospital of Wuhan University all participants were randomized in a parallel-group trial; 31 patients were assigned to receive 5-days of hydroxychloroquine (400 mg/days). The investigators found that for the 62 COVID-19 patients, they found that body temperature recovery time and the cough remission time were significantly shortened in the treatment group. They found that among patients with COVID-19, the use of the experimental treatment did shorten TTCR (body temp recovery time and cough) and promote absorption of pneumonia. Some western commenters note that this paper is not peer-reviewed yet and there could be issues with translation of the materials essentially confusing some of the interpretations, but the hope is post-review clarity will emerge.

The University of Oxford study—covered in TrialSite News—plans a large-scale clinical trial to test the use of hydroxychloroquine on up to 40,000 healthcare participants between 50-100 sites. The prestigious UK institution via the Mahidol Oxford Tropical Medicine Research Unit in Thailand will hopefully provide the mass amount of data needed to come to some conclusions about the use of hydroxychloroquine and its effectiveness against COVID-19.  Dr. William Schilling serves as the co-investigator for this important study that starts April 2020 and runs through April 2021. Hopefully data will be shared prior to then.


Although authorities such as the FDA have issued emergency authorizations to use this antimalarial drug on COVID-19 patients; and of course perhaps the most influential role on the planet—U.S. President—suggests the drug is a “game changer”, no one can be certain because there isn’t enough data aggregated, analyzed and synthesized in the form of clinical evidence to make such declarations. Hence, only ongoing clinical trials using hydroxychloroquine used on large numbers of COVID-19 patients can lead medical professionals to a certain conclusion.


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