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There are nations that have banned its sale, while there are those that still have faith! Hydroxychloroquine has created a rift across the world and even the scientific community as a whole. No knows for sure whether or not hydroxychloroquine actually works, but there are those who believe in the positive effects the drug has on patients diagnosed as COVID-19 positive. But, quite naturally, there are those who have strong reservations against using hydroxychloroquine for the treatment of COVID-19 patients. And, that brings us to the great divide that the world’s facing today! 

The Hydroxychloroquine Story 

Hydroxychloroquine is predominantly used for the treatment of arthritis and malaria. However, lack of any vaccination or medication against COVID-19 led to doctors and researchers across the globe try alternate medications that are licensed for human use. It was then that a group of scientists started using hydroxychloroquine as an alternate medication on a test basis. However, the social media was quick to catch up to this, and there were messages circulating about possible treatment for COVID-19 in the form of hydroxyl chloroquine. This led to an increased demand for the drug across various countries. To add fuel to the fire, prominent personalities, such as Donald Trump, the President of the United States of America, endorsed the use of the drub publicly during a press conference. 

Despite the serious side effects, the use of hydroxychloroquine as an intermediate solution started becoming quite popular. People even started hoarding medicine for personal use. However, there remain risks, and it was not long before some independent agencies started to point out the flaws. 

The Lancet Study 

The Lancet study, which recently got published, created a deeper rift in this debate, clearly demarcating the ones who are in support of the use of the drug from the ones who are not. The study shook the scientific world since it clearly claims that the use of hydroxychloroquine or chloroquine, both with or without a combination of second-generation macrolide, shows no positive impact in the treatment of COVID-19. The safety and benefits of the use of the medicines for the treatment of COVID-19 are evaluated extremely poorly. 

Methodology Of The Lancet Study

The Lancet study methodology is explicitly explained on the website, where the detailed report has been published. As per the report, this was a multinational registry analysis on the use of hydroxychloroquine and chloroquine, both with and without a macrolide for the treatment of COVID-19. This study was conducted on the data collected from 671 hospitals spread across six continents between December 20, 2019, and April 14, 2020. 

The patients were distributed in the four groups as per the treatment they received – chloroquine only, chloroquine with macrolide, hydroxychloroquine only, and hydroxychloroquine with a macrolide. The control group was formed of the ones who did not receive any such treatment. The study excluded the patients for whom the treatment was initiated more than 48 hours of a positive diagnosis of COVID-19, or while the patients were already on a mechanical ventilator. Moreover, the patients who received remedesivir were excluded from the study. 

The objective of the study was to log the outcomes of the treatment in the form of in-hospital mortality and the occurrence of de-novo ventricular arrhythmias, which includes both non-sustained and sustained ventricular tachycardia or ventricular fibrillation. 

Findings Of The Lancet Study

The total number of patients admitted with COVID-19 during the study timeframe who met the inclusion criteria is 96,032. The mean age of the study group is 53.8 years, and the group consists of 46.3% women. The total number of patients who received the treatment of interest is 14,888. Out of the total count, 1,868 patients received chloroquine, 3,783 patients received chloroquine with a macrolide, 3,016 patients received hydroxychloroquine, and 6,221 patients received hydroxychloroquine with a macrolide. The control group consisted of 81,144 patients. 

As per data received, 10,698 patients died in hospitals, which is 11.1% of the total number. After taking into consideration multiple confounding factors, such as, age, sex, ethnicity or race, BMI (body-mass index), smoking, underlying lung diseases, diabetes, underlying cardiovascular diseases and the associated risk factors, immunosuppressed condition, and baseline disease severity, the mortality rate of the various treatment groups is compared with the control group. The mortality rate of the control group was calculated at 9.3%. Compared to that, the mortality rate for hydroxychloroquine alone was at 18%, having a hazard ratio of 1.335, whereas, when used with a macrolide, the mortality rate stood at 23.8%, and hazard ratio stood at 1.447. For chloroquine, the figures for mortality rate and hazard ratio were found to be 16.4% and 1.365, respectively, while using a macrolide changed them to 22.2% and 1.368, respectively. This clearly showed that the in-hospital mortality rate increased with the use of the drugs for the treatment of COVID-19. 

The research also included checking the risk of occurrence of de-novo ventricular arrhythmia during hospitalization. When compared with the control group, that showed mortality rate due to the de-novo arrhythmia during hospitalization to be at 0.3%, the mortality rate and hazard ratio for hydroxychloroquine only were calculated at 6.1% and 2.369 respectively, while, when the treatment included the use of a macrolide, the same were at 8.1% and 5.106 respectively. For chloroquine treatment, the mortality rate associated with an increased risk of de-novo ventricular arrhythmia was calculated at 4.3%, and the hazard ratio was at 3.561, whereas, the use of a macrolide shifted the figures to 6.5% and 4.011 respectively. 

Conclusion By The Lancet

The Lancet, based upon its findings, clearly objected to the use of either chloroquine or hydroxychloroquine, both, with and without a macrolide, for the treatment of the COVID0-19 patients. The findings suggested that there is no direct benefit associated with the use of drugs. Whereas, as feared, the administration of the drugs was increasing the risk of the associated side-effects in cases where the drug is not needed in general by the patient. Moreover, the mortality rate showed a sharp rise as well, as compared to the control group. 

The Lancet Under Review

Ever since the study was published by Lancet, there has been quite a buzz across the world. World Health Organization (WHO) put a stop to all clinical trials of HCQ on COVID-19 patients. However, the study published by The Lancet came under scrutiny due to the alleged discrepancy in the data published within the study. For starters, many peer reviewers pointed out the extremely short duration that was taken to study such a massive amount of data. To conclude conclusively, after in-depth research of such huge data within the timespan mentioned is not common and can easily cause mistakes. Moreover, the refusal of the author to provide details of the source of the data further put questions on the authenticity of the data mentioned in the review. 

Furthermore, an independent investigation by The Guardian showed plenty of discrepancies, one of them being the data from Australia. While the Lancet review mentioned that there had been 73 deaths out of the 600 COVID-19 patients admitted in Australia as of April 21, 2020, the data with the Johns Hopkins University, US, stated that Australia recorded 63 deaths as of April 23, 2020. 

In response to these allegations, The Lancet researchers clarified that there had been some errors in the classification of some hospitals that led to the hospitals from Asia to be classified under Australia, resulting in the data discrepancy. However, The Lancer stood firm when the integrity of the study was brought under question. 

Implications Of The Study

It can be quite convincingly said that there were indeed few valid discrepancies in the study published by The Lancet, as already confirmed by the medical journal. However, this cannot put the entire study and its findings into question. There is still no clear evidence about the benefit of the use of hydroxychloroquine when administered to COVID-19 patients. However, this study has certainly put the trials on pause across the world. Many major countries, such as France, Italy, Egypt, Tunisia, Columbia, Chile, El Salvador, Cape Verde, Albania, and Bosnia and Herzegovina, stopped the trials.  

Having said so, there are countries that still put their faith in the drugs, namely, Brazil, Algeria, Morocco, Turkey, Jordan, Romania, Portugal, Kenya, Senegal, Chad and the Republic of Congo. 

This report certainly creates a negative impact on the mentality of volunteers for the study. It is expected that the report being published will demotivate volunteers from participating in such studies. However, clinical trials are continuing in many countries, and at a time when there is no known drug for COVID-19, it can be said with certainty that these trials will continue till some concrete evidence comes to light.