Consumers worldwide are stockpiling and self medicating on drugs — chloroquine, hydroxychloroquine, ritonavir and umifenovir — that have been hyped as cures on social media and by President Donald Trump, but have so far shown no efficacy in clinical trials, writes MedicalBrief.
There are currently no approved drugs to prevent or treat COVID-19, but malaria drug chloroquine, hydroxychloroquine — a more tolerable form of chloroquine — HIV combo therapy Kaletra (ritonavir), and influenza med Arbidol (umifenovir) are among top candidates for repurposing for the treatment of the coronavirus.
South Africa’s medicines regulator has warned consumers to stop buying chloroquine in anticipation of COVID-19 infection, saying there is no evidence that it combats the coronavirus. According to a Business Day report, the regulator also said stockpiling the drug could deprive patients in dire need of the product.
Media reports of chloroquine being investigated as a potential therapy for the respiratory disease, along with widely reported comments by US President Donald Trump inaccurately describing it as showing “very encouraging results” have fuelled consumer interest around the globe.
The report says a US man died after self-medicating with chloroquine, and on Monday health officials in Nigeria sounded a warning after three people over-dosed on the drug.
The South African Health Products Regulatory Authority (Sahpra) said it had asked pharmacies to step up their management of products containing chloroquine to help curb stockpiling, and ensure the drug remained available for patients who needed it.
The report says chloroquine is no longer widely prescribed for preventing or treating malaria, but is still required in some cases, and is also used for treating severe rheumatoid arthritis.
Malaria drug chloroquine, AbbVie’s HIV combo therapy Kaletra and an influenza med called Arbidol are among top candidates that physicians are repurposing for the treatment of COVID-19. Fierce Pharma reports, however, that despite backing from officials, though, the three have disappointed separately in two Chinese clinical trials of mild patients.
Hydroxychloroquine, a more tolerable form of chloroquine, didn’t top placebo at clearing the coronavirus among mild Chinese patients, or helping them reach normal temperature sooner, Evercore ISI analyst Umer Raffat noted.
Separately, neither Kaletra – a combination of HIV antivirals lopinavir and ritonavir – nor Arbidol (umifenovir) delivered benefits in viral clearance or symptom relief compared with no antiviral treatment in a small Chinese study in mild-to-moderate COVID-19 patients, results show.
Still, the report says, these drugs may have other opportunities to prove their worth in the fight against COVID-19. For one, the World Health Organisation has unveiled plans for a large-scale global trial, dubbed Solidarity, to test promising antivirals in thousands of patients around the globe.
The treatments to be examined include Gilead Sciences’ remdesivir, chloroquine and hydroxychloroquine, Kaletra, and a cocktail of Kaletra plus interferon-beta.
Abstract
Background: The novel coronavirus pneumonia (COVID-19) outbreak has caused a global pandemic, however, effective antiviral therapeutics are still unavailable.
Methods: Our study (NCT04252885), designated as ELACOI, was an exploratory randomized (2:2:1) and controlled one, exploring the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy treating mild/moderate COVID-19 patients.
Results: This study successful enrolled 44 patients with mild/moderate COVID-19, with 21 randomly assigned to receive LPV/r, 16 to arbidol and 7 to no antiviral medication as control. Baseline characteristics of three groups were comparable. The median time of positive-to-negative conversion of SARS-CoV-2 nucleic acid was 8.5 (IQR 3, 13) days in the LPV/r group, 7 (IQR 3, 10.5) days in the arbidol group and 4 (IQR 3, 10.5) days in the control group (P=0.751). The positive-to-negative conversion rates of SARS-CoV-2 nucleic acid at day 7 and 14 did not show significant differences in the LPV/r group (42.9%, 76.2%), the arbidol group (62.5%, 87.5%) and the control group (71.4%, 71.4%) (all P>0.53). No statistical differences were found among three groups in the rates of antipyresis, cough alleviation, improvement of chest CT or the deterioration rate of clinical status (all P > 0.05). Overall, 5 (23.8%) patients in the LPV/r group experienced adverse events during the follow-up period. No apparent adverse events occurred in the arbidol or control group.
Conclusion: LPV/r or arbidol monotherapy seems little benefit for improving the clinical outcome of mild/moderate COVID-19. LPV/r might lead to more adverse events. Due to the limitation of small sample size, further verification is needed in the future.
Authors
Yueping Li, Zhiwei Xie, Weiyin Lin, Weiping Cai, Chunyan Wen, Yujuan Guan, Xiaoneng Mo, Jian Wang, Yaping Wang, Ping Peng, Xudan Chen, Wenxin Hong, Guangming Xiao, Jinxin Liu, Lieguang Zhang, Fengyu Hu, Feng Li, Feng Li, Fuchun Zhang, Xilong Deng, Linghua Li
Hydroxychloroquine, a medicine for malaria that President Donald Trump has touted as a treatment for coronavirus, was no more effective than conventional care, a small study found. According to a Bloomberg report, the study published by the Journal of Zhejiang University in China showed that patients who got the medicine didn’t fight off the new coronavirus more often than those who did not get the medicine.
The study involved just 30 patients. Of the 15 patients given the malaria drug, 13 tested negative for the coronavirus after a week of treatment. Of the 15 patients who didn’t get hydroxychloroquine, 14 tested negative for the virus.
The results of the study weren’t statistically significant.
The report says hydroxychloroquine, particularly when given with the antibiotic azithromycin, has received widespread attention following a controversial, small study of about 40 patients hospitalised with COVID-19 in France. In that study, the drug appeared to help clear the virus from the bodies of 26 patients who were given the medication, based on samples taken from nasal swabs.
Experts have criticised the design of the study, calling it interesting but far from definitive.
Trump has said several times that he is confident the medicine will work and, the report says, Vice President Mike Pence also touted the drug at a White House event. “Doctors can now prescribe chloroquine for that off-label purpose of dealing with the symptoms of coronavirus,” Pence said. “The president’s very optimistic.”
But, the report says, top scientists, including White House coronavirus task force member Anthony Fauci, have called reports that hydroxychloroquine might work anecdotal, and said they need further study before the pill’s use is encouraged.
Trump promoted the drug as a potential treatment for COVID-19 after Fox News spent days exaggerating the drug’s effectiveness, reports Media Matters. Much of the initial coverage of these drugs on Fox was spurred by a lawyer named Gregory Rigano. Rigano, who was described as an adviser to Stanford University’s medical school despite no actual affiliation, appeared on Fox multiple times to tout the potential benefits of these drugs.
The report says these drugs may eventually prove effective in treating COVID-19, but additional study is needed. Meanwhile, Fox hosts like Sean Hannity continue to recklessly promote these drugs to an audience that is understandably eager for a cure, with little evidence of their effectiveness.
On 12 March during a segment on Tucker Carlson Tonight, Fox medical contributor Dr. Marc Siegel was one of the first guests to mention hydroxychloroquine (also known as Plaquenil) as a possible treatment for coronavirus, noting that it has been used to treat patients in South Korea.
Siegel again mentioned hydroxychloroquine and chloroquine on 14 March on Justice with Judge Jeanine, stating that the use of the drug in other countries as a COVID-19 treatment appears “promising.”
On 16 March, Fox's Martha MacCallum asked Johns Hopkins professor Justin Lessler about potential use of chloroquine as a treatment.
Gregory Rigano made his first appearance to talk about COVID-19 on Fox News on The Ingraham Angle later that night. Rigano, identified as a co-author of a study on chloroquine, promoted the small study mentioned above.
On 17 March, Fox host Laura Ingraham asked coronavirus task force member Dr Anthony Fauci about the drugs, and he explained that they still require further study.
Rigano made his second appearance on Fox News during the 18 March edition of Tucker Carlson Tonight, this time erroneously identified as an adviser to Stanford Medical School. Rigano again promoted the small study in France and pushed for Trump to allow the use of hydroxychloroquine as a treatment for COVID-19.
That same night, Fox's Sean Hannity began touting the potential uses of chloroquine and asked a panel of doctors whether the drug could be used prophylactically.
Later, Ingraham asked Secretary of Health and Human Services Alex Azar if the Trump administration has considered fast-tracking trials of chloroquine and hydroxychloroquine.
After Trump promoted hydroxychloroquine and chloroquine in his press conference on 19 March, Carlson interviewed the CEO of Vanda Pharmaceuticals to discuss the drugs. Hannity praised Trump’s focus on chloroquine and hydroxychloroquine and incorrectly claimed that Rigano’s study was done in “consultation with Stanford University School of Medicine, UAB School of Medicine.”
Later in the same 19 March show, Hannity told Administrator for the Centres for Medicare and Medicaid Services Seema Verma that he personally would use the drugs Trump promoted if he had COVID-19.
On her show that night, Ingraham boasted that the actions Trump took in his earlier press conference were due in part to the “persistence of The Ingraham Angle.” On 20 March, Hannity told listeners of his radio show that he would be “all over” these drugs if he had COVID-19 and encouraged listeners to stock up on hydroxychloroquine if they thought they had symptoms.
That night on his show, Hannity forgot the name “hydroxychloroquine” while exaggerating its proven effectiveness in treating COVID-19.
Also that night, Ingraham took issue with Fauci’s characteriSation of the evidence supporting the effectiveness of these drugs as “anecdotal.”
On 21 March, in an interview with Secretary of Housing and Urban Development Ben Carson, Fox's Jeanine Pirro praised Trump for pushing for the use of these drugs in compassionate use cases.
On 23 March on Fox & Friends, host Ainsley Earhardt pushed for the use of hydroxychloroquine in combination with azithromycin, or Z-Pak.
Dr Mehmet Oz appeared on Fox & Friends and also promoted the same small study, saying his “jaw dropped” when he read the results.
Co-host of The Five Greg Gutfeld complained about a Bloomberg article pointing out the potential dangers of hydroxychloroquine.
That night, Hannity read Vice President Mike Pence a letter from an unidentified doctor who said that hydroxychloroquine in combination with azithromycin and zinc proved effective in treating COVID-19 patients.
In an interview that night with Dr Oz, Ingraham played clips of his interview with the French doctor behind the small hydroxychloroquine study and downplayed the study’s limitations by stating that six patients were excluded “for whatever reason.”
On Sunday, a couple in Arizona who had heard the president describe the drug on television, and were afraid of dying from COVID-19, discovered that they had a version of the chemical chloroquine phosphate, used to clean fish tanks, among their pet supplies.
The Intercept reports that mistakenly believing that the chemical sold to pet owners, which is available online, was the same as the anti-malaria drug prescribed for humans – it is not – the man, who was 68, and his wife, who was 61, tried to self-medicate by mixing one teaspoon of the bitter tasting chemical with soda and swallowing it. Within 30 minutes, both fell ill and had to be rushed to a Phoenix-area hospital, where the man died and his wife remains under critical care.
Trump’s press conference statement about the possible benefit of the form of chloroquine prescribed by doctors for malaria “was on a lot,” the woman is quoted in the report as saying. “They kept saying that it was approved for other things and, you know, Trump kept saying it was basically pretty much a cure.”
“Given the uncertainty around COVID-19, we understand that people are trying to find new ways to prevent or treat this virus, but self-medicating is not the way to do so,” said Dr Daniel Brooks, the medical director of the Banner Poison and Drug Information Centre in Phoenix in the report.
[link url="https://www.businesslive.co.za/bd/national/health/2020-03-24-medicines-regulator-warns-consumers-not-to-use-malaria-drug-for-covid-19/"]Full Business Day report[/link]
[link url="https://www.fiercepharma.com/pharma-asia/top-covid-19-aspirants-chloroquine-abbvie-s-kaletra-and-a-flu-drug-disappoint-clinical"]Full Fierce Pharma report[/link]
[link url="https://www.medrxiv.org/content/10.1101/2020.03.19.20038984v1"]MedRxiv study[/link]
[link url="https://www.bloomberg.com/news/articles/2020-03-25/hydroxychloroquine-no-better-than-regular-covid-19-care-in-study"]Full Bloomberg report[/link]
[link url="http://subject.med.wanfangdata.com.cn/UpLoad/Files/202003/43f8625d4dc74e42bbcf24795de1c77c.pdf"]Journal report[/link]
[link url="https://www.mediamatters.org/coronavirus-covid-19/trump-promoting-unproven-covid-19-cure-after-reckless-speculation-fox-news"]Media Matters report[/link]
[link url="https://theintercept.com/2020/03/24/trump-hyped-chloroquine-cure-covid-19-man-arizona-took-died/"]Full report in The Intercept[/link]