The World Health Organization (WHO) announced today that it is halting its trials of the hydroxychloroquine and HIV treatment lopinavir/ritonavir in patients hospitalized with the coronavirus after results showed the drugs did not reduce mortality rates. This was announced in a press release by the agency.
This step to halt the trial was taken at the recommendation of the drug trial’s international steering committee. The study of which these treatments were a part of will continue and still study other methods of treatment for patients with COVID-19. WHO is also examining the potential effect of remdesivir, an anti-viral drug from Gilead, on COVID-19 within this study.
Interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized #COVID19 patients when compared to the existing standard of care.
— World Health Organization (WHO) (@WHO) July 4, 2020
Hydroxychloroquine (sold under the name, Plaquenil) is a drug typically used to treat malaria and rheumatoid arthritis. It is the less toxic version of the drug chloroquine which is also used to treat malaria.
The drug first came into limelight during the COVID-91 pandemic when US president Donald Trump claimed that the drug works and he takes hydroxychloroquine despite FDA warnings regarding heart arrhythmias and other side effects.
Evidence Against Hydroxychloroquine
But the mounting evidence against the effectiveness of this treatment led the United States Food and Drug Administration to revoke emergency use authorization for hydroxychloroquine in COVID-19.
Based on continued review of scientific data, FDA has determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating #COVID19 and therefore we are revoking the emergency use authorization for these drugs: https://t.co/k9kJMeci0a pic.twitter.com/W2aItvFcBU
— FDA Drug Information (@FDA_Drug_Info) June 15, 2020
Many other trials have also been halted due to similar results. The National Institutes of Health trial testing efficacy of the antimalarial drug hydroxychloroquine in COVID-19 patients was one of them. The study showed that the drug neither harmed the participants nor did it provide any clinical benefits.
In June, scientists from Oxford University announced that hydroxychloroquine provides no benefit in patients hospitalized with COVID-19. In light of these findings they officially stopped the hydroxychloroquine arm of the RECOVERY trial and stopped enrolling patients.
— University of Oxford (@UniofOxford) June 5, 2020
The hydroxychloroquine trial in New York also concluded that the patients taking hydroxychloroquine were just as likely to need a ventilator and to die, then the ones not getting the drug, same as the evidence coming out of China.
Swiss pharmaceutical company, Novartis also halted its trial of hydroxychloroquine against COVID-19 because they could not find volunteers to enroll in the study in light of these recent revelations. They had planned to enroll at least 400 patients in the trial but could only find a handful which was not enough for conclusive results.
Novartis $NVS announced today they would be stopping their clinical trial of hydroxychloroquine as a treatment for COVID-19 immediately. $NVS said they weren't able to find enough willing participants to partake in the trial and therefore their data wouldn't have been meaningful pic.twitter.com/zQ3RFXsHD4
— Stock Market News (@StockMKTNewz) June 19, 2020
Lower Death Rates
Another recent study however found the opposite evidence. The study released just this week found that the use of hydroxychloroquine by COVID-19 patients is linked to lower death rates. It was announced in a press release by the organization conducting the study.
The study was conducted by Michigan’s Henry Ford Health System and concluded that hydroxychloroquine “significantly” lowered the mortality rate among COVID-19 patients.
In a peer-reviewed study of 2,541 patients hospitalized at Michigan’s six Henry Ford hospitals during the coronavirus peak, scientists found that hydroxychloroquine “cut the death rate significantly” without “heart-related side-effects.” https://t.co/CbwKyqQWPY pic.twitter.com/6BWINcWSw1
— Ellen Carmichael (@ellencarmichael) July 3, 2020
In patients who received the drug, the death rate was 13 percent as compared to people who were not given the drug with death rate of 26.4 percent.
“We attribute our findings that differ from other studies to early treatment, and part of a combination of interventions that were done in supportive care of patients, including careful cardiac monitoring. Our dosing also differed from other studies not showing a benefit of the drug”, said Marcus Zervos, co-author of the study and division head of Infectious Disease for Henry Ford Health System, said in the statement.
He also added that the findings were highly analyzed and peer reviewed.
Three big studies this past week in support of HYDROXYCHLOROQUINE:
HCQ/AZ/Zn, 99.3% outpatient survival rate (Zelenko): https://t.co/7fVZyhjPFQ
HCQ reduces mortality by >50% (Henry Ford): https://t.co/5rjSRMFOba
HCQ+AZ w/ 0.5% mortality rate (Raoult) : https://t.co/cuwKlVizyk
— James Todaro, MD (@JamesTodaroMD) July 3, 2020
However, this is not the end of hydroxychloroquine research related to COVID-19, just on Friday, the Medicines and Healthcare Products Regulatory Agency’s global trials of hydroxychloroquine and chloroquine, resumed.
Lopinavir/Ritonavir for COVID-19 Infection
Lopinavir/ritonavir is a fixed dose combination medication for the treatment and prevention of HIV and AIDS. It combines lopinavir with a low dose of ritonavir.
When COVID-19 pandemic hit the world, this drug combination was one of the few identified which could possibly treat COVID-19 patients. To check this theory, many trials on the drug were initiated.
One of these trials by the WHO (Solidarity Trial) now has found that lopinavir/ritonavir produces little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.
Independent confirmation of RECOVERY results. WHO discontinues hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 https://t.co/J4mzTFIv8m
— Peter Horby (@PeterHorby) July 4, 2020
This is not the only evidence against the drug, the UK Recovery trial also found that the drug is not effective to treat coronavirus patients. The results showed no significant difference in the primary endpoint of 28-day mortality, in the trial. Researchers also reported no evidence of beneficial impact on the risk of progression to mechanical ventilation or duration of hospital stay.
No benefit from HIV antiviral in treatment of Covid-19 according to huge UK trial. Study of nearly 6,000 hospital patients as part of Recovery trial found lopinavir-ritonavir did not improve survival @MartinLandray @PeterHorby
— Fergus Walsh (@BBCFergusWalsh) June 29, 2020