Remdesivir becomes first Covid-19 treatment to receive FDA approval (October 22) – The drug, sold under the brand name Veklury, has been used under emergency use authorization. Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a US study found the infused drug shortened recovery time for some patients by about a third. The FDA uses data submitted by a drug’s maker when it’s considering approval. Gilead submitted a study published in the New England Journal of Medicine that showed the drug shortened the course of illness from an average of 15 days to about 11 days in hospitalized patients.The FDA also considered two other studies. One showed a slight benefit of the drug and another showed the drug did not make much difference.
Regeneron’s Antibodies Prevent and Treat SARS-CoV-2 Infection in Monkeys (October 13) – A new report evaluates the in vivo efficacy of the Regeneron antibody cocktail in both rhesus macaques and golden hamsters, which may model more severe disease. The study demonstrates that REGN-COV-2 can greatly reduce virus load in lower and upper airways and decrease virus-induced pathological sequelae when administered prophylactically or therapeutically in rhesus macaques.
Scientists Find An Avenue To Attack The Coronavirus, Aided By Cloud Imaging (September 22) – Findings discussed may let doctors one day administer drugs to COVID-19 patients that interact with the spike protein at the site where it captures linoleic acid, one of the body’s essential fatty acids that’s absorbed through food. See the original Science paper published this week.
F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say (August 28) – Dr. Stephen M. Hahn, the F.D.A. commissioner, erroneously stated that convalescent plasma would have saved 35 percent of coronavirus patients this year. Scientists were taken aback by the way the administration framed this data, which appeared to have been calculated based on a small subgroup of hospitalized Covid-19 patients in a Mayo Clinic study: those who were under 80 years old, not on ventilators and received plasma known to contain high levels of virus-fighting antibodies within three days of diagnosis. Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where the statistic came from.
Protein Interactions Point the Way to Drugs Against COVID-19 (August 4) – A recent Cell report details findings on how SARS-CoV-2 modifies proteins within infected host cells to enhance the virus’s ability to invade neighboring cells. These viral modifications involve a route of infection not previously seen in the family of coronaviruses. The report also specifies at least half a dozen existing drugs that — with further testing and official approval — could be pressed into service against the virus.
Engineering human ACE2 to optimize binding to the spike protein of SARS coronavirus 2 (August 4) – A stable dimeric variant shows potent SARS-CoV-2 and -1 neutralization in vitro. The engineered receptor is catalytically active and its close similarity with the native receptor may limit the potential for viral escape.
Data show panic and disorganization dominate the study of Covid-19 drugs (July 6) – 1,200 clinical trials aimed at testing treatment and prevention strategies. Analysis found many of the studies are so small — 39% are enrolling or plan to enroll fewer than 100 patients — that they are unlikely to yield clear results. About 38% of the studies have not actually begun enrolling patients.
Gilead announces price for Covid-19 drug remdesivir (June 29) – The vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient.
Gilead to Test Inhaled Form of Remdesivir in COVID-19 Starting in August (June 22) – The company expects to begin screening healthy volunteers for the Phase I trial this week with plans to begin clinical studies in August. If it works, the drug could be given to patients using a nebulizer, which would allow for easier dosing outside the hospital and potentially in earlier stages of the disease.
Inexpensive, Widely Available Steroid Saved Lives in Large COVID-19 Clinical Trial (June 17) – A large clinical trial in the U.K. has found that dexamethasone, a cheap and widely available steroid, decreased the risk of death in severely ill COVID-19 patients. The preliminary results, which have not been peer-reviewed, suggest the drug could become standard care in COVID-19 severe patients.
Collecting Genomic Data to Accelerate COVID-19 Drug Discovery (June 9) – Mount Sinai researchers have developed the COVID-19 Gene Set and Drug Library to leverage genomic data and facilitate collaborative drug discovery.
Rules for Clinical Trials in a Pandemic (June 21) – A new study finds that adding a simple steroid to the treatment of severe Covid-19 cases can significantly reduce deaths. That’s another milestone in the battle against the virus. It shows a path for reducing Covid deaths faster through medical innovation and for keeping the health-care system from being overwhelmed as the epidemic spreads. Discussing also that the US case-death dissociation is primary due to more young people infected and better protection of the older age groups. An Oped piece by Scott Gottlieb and Mark McClellan.
NIH launches analytics platform to harness nationwide COVID-19 patient data to speed treatments (June 15) – The National Institutes of Health has launched a centralized, secure enclave to store and study vast amounts of medical record data from people diagnosed with coronavirus disease across the country. It is part of an effort, called the National COVID Cohort Collaborative (N3C), to help scientists analyze these data to understand the disease and develop treatments. This effort aims to transform clinical information into knowledge urgently needed to study COVID-19, including health risk factors that indicate better or worse outcomes of the disease, and identify potentially effective treatments.
Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies (June 15) – The spike protein is a key mediator of viral infectivity required for attachment and entry into target cells by binding the ACE2 receptor. Success of combination therapy for HIV demonstrated that requiring the virus to simultaneously mutate at multiple genetic positions may be the most effective way to avoid drug resistance. This study describes a parallel effort.
FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use (June 15) – Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
Eli Lilly starts trial of rheumatoid arthritis drug in COVID-19 patients (June 15) – The trial began dosing patients last week and plans to enroll around 400 patients globally. Lilly could potentially obtain U.S. regulatory approval for the drug as soon as August.
Covid-19 Patient Gets Double Lung Transplant, Offering Hope for Others (June 11) – The operation is believed to be the first of its kind in the U.S. The patient, a woman in her 20s, had been healthy, but the coronavirus devastated her lungs.
WHO Resumes Study of Hydroxychloroquine for Treating COVID-19 (June 4) – On June 3, the World Health Organization (WHO) resumed a study looking into whether the malaria drug hydroxychloroquine could be effective in treating COVID-19.
Lancet, New England Journal retract Covid-19 studies, including one that raised safety concerns about malaria drugs (June 4) – The retracted influential study that raised alarms about the safety of the experimental Covid-19 treatments chloroquine and hydroxychloroquine amid scrutiny of the data underlying the paper. Just over an hour later, the New England Journal of Medicine retracted a separate study, focused on blood pressure medications in Covid-19, that relied on data from the same company. The retractions came at the request of the authors of the studies, published last month, who were not directly involved with the data collection and sources, the journals said.
Gilead’s remdesivir shows some benefit in patients with moderate Covid-19, new data show (June 1) – The new data, from a study conducted by the company, add to the evidence that the medicine is at least somewhat effective treatment for Covid-19. But they will also likely add to the debate of exactly how effective the remdesivir is, and in what patients.
Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis (May 22) – There is no evidence of benefit for chloroquine and hydroxychloroquine in COVID- 19 patients: finding from a large observational study of nearly 14,888 patients with COVID-19 & 81,000 controls.
Dozens of coronavirus drugs are in development — what happens next? (May 14) – Drug manufacturers face supply-chain weaknesses and sourcing issues as they ramp up complex production processes to meet global demand.
NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19 (May 14) – A clinical trial has begun to evaluate whether the malaria drug hydroxychloroquine, given together with the antibiotic azithromycin, can prevent hospitalization and death from coronavirus disease 2019 (COVID-19).
As We Wait For a Vaccine, Scientists Eye Antibodies (May 12) – As new information emerges about the effectiveness of the antibody response in people infected with the SARS-CoV-2 virus — including a study showing that most people who tested positive produced antibodies — a monoclonal antibody treatment for this pandemic is growing more appealing. In theory, it could even be given prophylactically to high-risk individuals to create short-term protection against future infection.
Old Drugs May Find a New Purpose: Fighting the Coronavirus (April 30) – Driven by the pandemic’s spread, research teams have been screening thousands of drugs to see if they have this unexpected potential to fight the coronavirus. They’ve tested the drugs on dishes of cells, and a few dozen candidates have made the first cut.
Hopes rise for coronavirus drug remdesivir (April 29) – Remdesivir interferes with the replication of some viruses, including SARS-CoV-2, which is responsible for the current pandemic. A clinical trial in more than 1,000 people showed that those taking remdesivir recovered in 11 days on average, compared with 15 days for those on a placebo. Also on 29 April, a smaller trial run in China announced that it had found1 no benefits from remdesivir when compared with a placebo. But that trial was stopped early owing to difficulty in enrolling participants as the outbreak subsided in China.
New Gilead remdesivir data likely enough for speedy FDA approval (April 29) – While no data have yet been revealed, the news “confirms positive results that met the efficacy endpoint (improved time to recovery)” in a very large test (as it has more than 1,000 patients).
STAT COVID-19 Drugs & Vaccines tracker (April 27) – A guide to some of the most talked-about efforts to treat or prevent coronavirus infection, with details on the science, history, and timeline for each endeavor. This tracker tracks novel medicines, not repurposed drugs.
New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope (April 23) – The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.” A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.
Two studies have some good news and bad news for potential coronavirus treatments (April 11) – New studies on hydroxychloroquine and remdesivir.
Structure of Mpro from COVID-19 virus and discovery of its inhibitors (April 9) – In order to identify new drug leads that target the COVID-19 virus main protease (Mpro) combined structure-assisted drug design, virtual drug screening and high-throughput screening was applied to identify new drug leads. This paper discusses a mechanism-based inhibitor, N3, identified by computer-aided drug design and the crystal structure of COVID-19 virus Mpro in complex with this compound. Mpro is a key CoV enzyme, which plays a pivotal role in mediating viral replication and transcription, making it an attractive drug target for this virus.
‘No miraculous recovery’: Some ICU doctors say hydroxychloroquine isn’t helping sickest patients (April 8) – Many doctors suspect that if the drug does turn out to be beneficial, it may work better early on in the course of the illness.
Roche Accelerates Phase III Actemra Trial in COVID-19 (April 8) – Actemra/RoActemra (tocilizumab), an anti-IL-6 receptor biologic currently approved to treat rheumatoid arthritis, is being evaluated in a randomized, double-blind, placebo-controlled Phase III trial in collaboration with BARDA, for safety and efficacy in hospitalized patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
Drug repurposing in SARS-CoV-2 / COVID-19: preventing the maladaptive immune response leading to critical disease requirement ICU care (April 8) – This blog post by Robert Plenge discusses the repurposing of anti-inflammatory drugs to prevent a cytokine storm, as the immune system is critical in the fight against SARS-CoV-2 infection – download a PDF of the blog post.
Gilead To Donate 1.5M Doses Of Experimental Coronavirus Treatment: ‘The Right Thing To Do’ (April 5) – Gilead donates 1.5 million doses of remdesivir, its investigational drug for COVID-19, for compassionate use, expanded access and clinical trials. The doses are intended for patients with severe symptoms who will receive them intravenously on a daily basis in a hospital setting which could amount to more than 140,000 treatment courses in COVID-19 patients, depending on the duration of treatment. Remdesivir was first developed by Gilead as a potential treatment for the Ebola and Marburg viruses. Multiple clinical trials for the drug are underway in COVID-19 with thousands of patients worldwide participating.
World’s largest trial of potential coronavirus treatments rolled out across the UK (April 3) – A number of promising treatments are being tested and, if the science supports it, will be given to NHS patients as quickly as possible. Definitive results on whether the treatments are safe and effective are expected within months and, if positive, they could potentially benefit hundreds of thousands of people worldwide. Almost 1,000 patients from 132 different hospitals have been already recruited in just 15 days and thousands more are expected to join the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial in the coming weeks, making it the largest randomised controlled trial of potential COVID-19 treatments in the world.
Amgen teams up with Adaptive to both treat and prevent COVID-19 (April 2) – The goal of this collaboration is to develop fully human neutralizing antibodies targeting the COVID-19-causing virus, SARS-CoV-2.
An experimental peptide could block Covid-19 (March 27) – MIT chemists are testing a protein fragment that may inhibit coronaviruses’ ability to enter human lung cells.
‘This is insane!’ Many scientists lament Trump’s embrace of risky malaria drugs for coronavirus (March 26) – Many scientists have criticized the French trial as riddled with enough methodological flaws to render its findings unreliable or misleading. Biostatisticians from the United Kingdom and Ireland cited a basic failure: Investigators didn’t randomize the groups – essential to ensuring dependable comparisons. They also noted that six of the treated patients were lost to the study, five of whom fared badly—one died, three entered intensive care, and one stopped treatment because of nausea. Yet they were dropped from the analysis, potentially skewing the outcome. Among the immediate consequences: Shortages of the drug are endangering patients who need it for lupus or rheumatoid arthritis.
Gilead asks FDA to take back lucrative orphan drug status on possible coronavirus treatment (March 25)
WHO launches global megatrial of the four most promising coronavirus treatments (March 22) – The large global trial is called SOLIDARITY. When a person with a confirmed case of COVID-19 is deemed eligible, the physician can enter the patient’s data into a WHO website, including any underlying condition that could change the course of the disease, such as diabetes or HIV infection. The participant has to sign an informed consent form that is scanned and sent to WHO electronically. After the physician states which drugs are available at his or her hospital, the website will randomize the patient to one of the drugs available or to the local standard care for COVID-19. The design is not double-blind, the gold standard in medical research, so there could be placebo effects from patients knowing they received a candidate drug. But WHO says it had to balance scientific rigor against speed.
As the coronavirus spreads, a drug that once raised the world’s hopes is given a second shot (March 16) – Remdesivir, in the spotlight as scientists and governments scramble to find a treatment for the disease, took a circuitous route to center stage. Born as a general antiviral candidate, researchers threw it at an array of viruses and saw where it stuck. For years, Gilead was primarily focused on ushering remdesivir into trials and toward approval for a different kind of infection: Ebola. Remdesivir is now being tested in five Covid-19 clinical trials that have been set up at breakneck speed.
NIH clinical trial of remdesivir to treat COVID-19 begins (Feb 25) – Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses. Clinicians will regularly monitor participants and will assign them daily scores based on a predefined scale of clinical outcomes that considers factors such as temperature, blood pressure and use of supplemental oxygen, among others. Participants also will be asked to provide blood samples and nose and throat swabs approximately every two days. Researchers will test these specimens for SARS-CoV-2.
