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Tuesday, January 26, 2021

No evidence of benefit for chloroquine, hydroxychloroquine in Covid-19 patients, urgent randomised trials needed: Lancet

Authors of the study suggest these drug regimens should be used to treat Covid-19 outside of clinical trials and urgent confirmation from randomised clinical trials is needed.

Written by Anuradha Mascarenhas | Pune | May 22, 2020 11:40:13 pm
coronavirus drug, Covid 19 patient, Corona cases, Lancet study, indian express news The study analysed data from nearly 15,000 patients with Covid-19 receiving a combination of any of the four drug regimens and 81,000 controls. (Representational)

A new study, reported on Friday in The Lancet, has found that the use of chloroquine or hydroxychloroquine is linked to increased rates of mortality and heart arrhythmias among patients with Covid-19.

Authors of the study suggest these drug regimens should be used to treat Covid-19 outside of clinical trials and urgent confirmation from randomised clinical trials is needed.

Professor Dr Frank Ruschitzka, director of Heart Centre at University Hospital Zurich, who co-authored the study, told The Indian Express over the phone that treatment with the antimalarial drug chloroquine, or its analogue hydroxychloroquine (taken with or without antibiotics azithromycin or clarithromycin), offers no benefit to patients of Covid-19.

“This is the largest observational study done so far. Clearly, the use of the drug for treating Covid-19 patient is harmful… It is reasonably safe to treat malaria. However, there is no benefit of this drug for Covid-19 patients. We have studied patients from across the world and there is no reason to assume Indian patients would do any better,” Dr Frank said.

The study analysed data from nearly 15,000 patients with Covid-19 receiving a combination of any of the four drug regimens and 81,000 controls. Treatment with these medications among patients with Covid-19, either alone or in combination with macrolide antibiotics, was linked to an increased risk of serious heart rhythm complications.

“Several countries have advocated the use of chloroquine and hydroxychloroquine, either alone or in combination, as potential treatments for Covid-19. Justification for repurposing these medicines in this way is based on a small number of anecdotal experiences that suggest they may have beneficial effects for people infected with the SARS-CoV-2 virus. However, previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed. However, we now know from our study that the chance that these medications improve outcomes in Covid-19 is quite low,” Dr Frank added.

Researchers suggest these treatment regimens should not be used to treat Covid-19 outside of clinical trials until results from randomised clinical trials are available to confirm the safety and efficacy of these medications.

Chloroquine is an antimalarial drug and its analogue, hydroxychloroquine, is used to treat autoimmune diseases including lupus and arthritis. Both drugs have a good safety profile as treatments for those specific conditions, and the findings do not imply patients should stop taking these drugs if they are prescribed for approved conditions. They have also been shown to have antiviral effects in laboratory tests and are therefore of interest as potential treatments for Covid-19.

Professor Dr Mandeep R Mehra, lead author of the study and Executive Director of the Brigham and Women’s Hospital Centre for Advanced Heart Disease in Boston, USA, said, “This is the first large- scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with Covid-19. Instead, our findings suggest it may be associated with an increased risk of serious heart problems or death. Randomised clinical trials are essential to confirm any harms or benefits associated with these agents. In the meantime, we suggest these drugs should not be used as treatments for Covid-19 outside of clinical trials.”

In the study, researchers analysed data from 96,032 patients hospitalised between December 20, and April 14 with laboratory confirmed SARS-CoV-2 infection from 671 hospitals. All patients included in the study had either been discharged or had died by April 21. The study involved researchers from the Brigham and Women’s Hospital and Harvard Medical School (USA), Surgisphere Corporation (USA), University Hospital Zurich (Switzerland), the University of Utah (USA) and HCA Research Institute (USA). It was funded by the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital.

The team compared outcomes from patients treated with chloroquine alone (1,868), hydroxychloroquine alone (3,016), chloroquine in combination with a macrolide (3,783) or hydroxychloroquine with a macrolide (6,221). Patients from these four groups were compared with the remaining control group of 81,144 patients.

At the end of the study period, around one in 11 patients in the control group had died in hospital (9.3 per cent, 7,530/81,144). All four of the treatments were associated with a higher risk of dying in hospital. Of those treated with chloroquine or hydroxychloroquine alone, around one in six patients had died (16.4 per cent, 307/1,868 chloroquine and 18.0 per cent, 543/3,016 hydroxychloroquine). When the drugs were used in combination with a macrolide, the death rate rose to more than one in five for chloroquine (22.2 per cent, 839/3,783) and almost one in four for hydroxychloroquine (23.8 per cent, 1,479/6,221). The team also found that serious cardiac arrhythmias, which cause the lower chamber of the heart to beat rapidly and irregularly, were more common in the groups receiving either of the four treatment regimens.

First Covid vaccine to reach phase 1 found to be safe

The first Covid-19 vaccine to reach phase 1 clinical trial has been found to be safe, well-tolerated, and able to generate an immune response against SARS-CoV-2 in humans, according to new research published in The Lancet on Friday. The open-label trial in 108 healthy adults demonstrates promising results after 28 days—the final results will be evaluated in six months. Further trials are needed to tell whether the immune response it elicits effectively protects against SARS-CoV-2 infection. Study of 108 adults finds vaccine produced neutralising antibodies and T-cell response against SARS-CoV-2, but further research is needed to confirm whether the vaccine protects against SARS-COV-2 infection, according to the report. The new Ad5 vectored COVID-19 vaccine evaluated in this trial is the first to be tested in humans. It uses a weakened common cold virus (adenovirus, which infects human cells readily but is incapable of causing disease) to deliver genetic material that codes for the SARS-CoV-2 spike protein to the cells. These cells then produce the spike protein, and travel to the lymph nodes where the immune system creates antibodies that will recognize that spike protein and fight off the coronavirus. The trial demonstrates that a single dose of the new adenovirus type 5 vectored Covid-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation, said Professor Wei Chen from Beijing Institute of Biotechnology in Beijing, who is responsible for the study.

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