RPT - Available COVID-19 Treatment Studies Too Preliminary Amid Race For Cure - WHO Expert

MOSCOW (Pakistan Point News / Sputnik - 26th April, 2020) Solid conclusions on safety and efficiency of potential treatment for the novel coronavirus respiratory disease, COVID-19, cannot be drawn without proper large-scale clinical trials, while available preliminary studies fail to meet these criteria due to hurry in the search for a cure, Professor Santiago Mas-Coma, the president of the World Federation for Tropical Medicine and an expert member of the World Health Organization, told Sputnik.

Scientists across the globe are currently working to find treatment to the COVID-19 disease, including by repurposing already existing antivirals, HIV and malaria drugs. One of medicines currently in focus of the global research efforts is hydroxychloroquine (HCQ). The drug has been touted by US President Donald Trump as a potential game-changer in the fight against the coronavirus pandemic after a French study found that patients treated with the combination of HCQ, an old malaria drug, and azithromycin, a common antibiotic, were getting their system cleared from the virus quicker.

However, another study of the drug by US researchers found the use of hydroxychloroquine does not reduce risk of mechanical ventilation and can actually cause higher mortality rate. Of a total 368 COVID-19 patients enrolled in the study, 97 patients who took HCQ without azithromycin had 27.8-percent death rate, 113 patients who received HCQ in combination with azithromycin - 22.1 percent, and remaining 158 patients not treated with HCQ at all - 11.4 percent.

In principle, proper clinical trials should meet several criteria. First of all, they should be randomized, which means that people are chosen at random to receive a certain medical intervention that is being studied. Secondly, trials should be controlled, which means that one group of participants should receive medical interventions, while others get placebo or no intervention at all. The makeup of these groups should be similar. Such randomized controlled trials, abbreviated as RCT, are called "the golden standard." To make a study more bias-free, such trials are sometimes "double-blind", which means that neither participants, nor researchers know who is receiving a studied treatment and who is not.

However, the alarming US study of HCQ is not even a clinical trial, Mas-Coma stressed.

"This is not a real trial, but simply a retrospective analysis of 368 cases from throughout the US, comparing patients in whom HCQ was used with others in which HCQ was not used. The problem of this paper is the mixture of patients with different characteristics and clinical pictures," the expert, who also works as director of parasitology at the University of Valencia, underlined.

The US study's preprint suggests caution in using hydroxychloroquine in hospitalized COVID-19 patients, especially when not combined with azithromycin, until randomized controlled trials of the drug emerge.

A group of Brazilian researchers, who has looked at another malaria drug and HCQ's close relative, chloroquine (CQ), has also made some alarming findings. According to the preprint of this randomized, double-blind study, researchers have found higher mortality rates from higher dosage of the drug and had to halt trials of higher dosage due to "potential safety hazards."

"A too short number of patients were enrolled, only 40 and 41, respectively. Very important is that there is no control group and therefore results are difficult to be interpreted," Mas-Coma underlined, commenting on the study's findings.

He also stressed that chloroquine was more toxic than hydroxychloroquine, while the study's subjects were only severely/critically ill patients, including those aged over 75 and having underlining conditions.

"Summing up, I sincerely do not see that the results of fatality rates obtained in this preliminary study may be considered significant. Moreover, this preliminary study only covers a 10-day follow-up. It should here be remembered that the French study furnishing apparent good results was with HCQ in mainly moderately ill patients. So, these two studies cannot be compared at all," the expert said.

Accordingly, both studies from the US and Brazil do not invalidate the results of the French study, Mas-Coma said, noting, however, that the French study too was also "very preliminary with an insufficient number of patients."

"All together, all such studies are the consequence of the need to work in hurry because of the very fast dissemination speed of the pandemic and the non-stop quick increase of deaths everywhere. No other way [to know whether a certain drug is efficient] than awaiting until good, appropriate studies with sufficient number of patients are finished," Mas-Coma concluded.

To date, the new strain of coronavirus causing the COVID-19 disease has infected over 2.7 million people globally, with over 193,000 fatalities, according to Johns Hopkins University.