Designer antibodies could battle COVID-19 before vaccines arrive

 While the world is transfixed by the high-stakes race to develop a COVID-19 vaccine, an equally crucial competition is heating up to produce targeted antibodies that could provide an instant immunity boost against the virus. Clinical trials of these monoclonal antibodies, which could both prevent and treat the disease, are already underway and could produce signs of efficacy in the next few months, perhaps ahead of vaccine trials. Science 

Why pregnant women face special risks from COVID-19

 The prescription for caregivers is simple, says David Baud, an expert on emerging infectious diseases and pregnancy at Lausanne University Hospital: “Protect your pregnant patients. The first ones who need the masks are pregnant women. The first to avoid social contact should be pregnant women. ScienceMagazine 

U.S. government begins two trials testing Eli Lilly’s coronavirus antibody drug

The trials, called ACTIV-2 and ACTIV-3, will look at U.S. drugmaker Eli Lilly’s experimental treatment known as LY-CoV555, which is being developed in partnership with Canadian biotech firm AbCellera. The companies announced Monday that they began a phase three trial testing whether the treatment can prevent the spread of coronavirus in residents and staff at nursing homes. CNBC

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NIH launches clinical trial to test antibody treatment in hospitalized COVID-19 patients

Patients admitted with COVID-19 at select hospitals may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease. The Phase 3 randomized, controlled trial is known as ACTIV-3, and as a “master protocol,” it is designed to expand to test multiple different kinds of monoclonal antibody treatments. It also can enroll additional volunteers in the middle of the trial, if a specific investigational treatment shows promise. NIH 

Scientists Uncover Biological Signatures of the Worst Covid-19 Cases

Scientists are beginning to untangle one of the most complex biological mysteries of the coronavirus pandemic: Why do some people get severely sick, whereas others quickly recover? In certain patients, according to a flurry of recent studies, the virus appears to make the immune system go haywire.

 Unable to marshal the right cells and molecules to fight off the invader, the bodies of the infected instead launch an entire arsenal of weapons — a misguided barrage that can wreak havoc on healthy tissues, experts said. The NewYork Times

Russia claims it's on track to approve Covid-19 vaccine by mid-August. But speed of process raises questions

Russia intends to be the first in the world to approve a coronavirus vaccine, in less than two weeks -- despite concerns about its safety, effectiveness and over whether the country has cut essential corners in development, CNN has learned. Russian officials told CNN they are working toward a date of August 10 or earlier for approval of the vaccine, which has been created by the Moscow-based Gamaleya Institute.

It will be approved for public use, with frontline healthcare workers getting it first, they said. CNNWorld 

Roche arthritis drug Actemra flunks COVID-19 study, but remdesivir combo data await

On the Covacta trial’s key secondary endpoint of death prevention by week four, a 19.7% death rate among Actemra patients didn't differ from the placebo group’s 19.4%. This marks the second major blow to the theory of targeting inflammatory molecule IL-6 in treating COVID-19. Earlier this month, Sanofi and Regeneron pulled the plug on a phase 3 trial of their rival IL-6 inhibitor Kevzara after finding the drug couldn’t help severely ill COVID-19 patients who were on mechanical ventilation. FiercePharma

Remdesivir approved to help treat Canadians with severe symptoms of COVID-19

An antiviral medication originally used to help treat Ebola has been approved by Health Canada for treatment of COVID-19. Health Canada announced Tuesday that the drug remdesivir has been authorized for treatment of the novel coronavirus in patients with severe symptoms such as pneumonia, or those who require extra oxygen to breathe. CTVNews 

First Phase 3 clinical trial of a coronavirus vaccine in the United States begins

The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes. Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Investigators and participants will not know who has received the vaccine. CNNHealth 

Can Masks Save Us From More Lockdowns? Here's What The Science Says

It seems obvious that masks would reduce the spread of a respiratory bug like the coronavirus to at least some degree. After all, when a healthy person wears a mask, the barrier filters out some airborne droplets containing the virus. Even more importantly, when a sick person wears a mask, the barrier holds in many of the viral droplets they exhale. NPR 

Study identifies 21 existing drugs that could treat COVID-19

Of the 21 drugs that were effective at blocking viral replication, the scientists found:

• 13 have previously entered clinical trials for other indications and are effective at concentrations, or doses, that could potentially be safely achieved in COVID-19 patients.
• Two are already FDA approved: astemizole (allergies), clofazamine (leprosy), and remdesivir has received Emergency Use Authorization from the agency (COVID-19).
• Four worked synergistically with remdesivir, including the chloroquine derivative hanfangchin A (tetrandrine), an antimalarial drug that has reached Phase 3 clinical trials.

Full Text-> ScienceDaily 

How Long Are You Contagious With Covid-19 Coronavirus? Here’s A CDC Update

The CDC is now saying that if you have mild-to-moderate Covid-19, keep yourself isolated from other people for at least 10 days after you first noticed symptoms. You can discontinue this isolation after the 10-day mark if you haven’t had a fever for at least 24 hours and your other symptoms have improved. Note that not having a fever because you took a fever-reducing medication like Tylenol doesn’t count. Forbes 

Yale to lead trial of potential COVID-19 treatment

Yale School of Medicine and the biopharmaceutical firm AI Therapeutics have launched a multi-institutional clinical trial of a drug for treating COVID-19. Known as LAM-002A (apilimod), the drug has a proven safety record. Preliminary research has shown it can block cellular entry and trafficking of the SARS-CoV-2 virus, the cause of COVID-19. YaleNews 

It's not just dexamethasone: Other steroids may be used to treat critically ill COVID-19 patients, study says

Dexamethasone isn’t the only steroid that has shown promise in the battle against COVID-19. Researchers at the Albert Einstein College of Medicine and Montefiore Health System led a study in which most of their patients took prednisone, another steroid in the same family as dexamethasone, and found patients with high inflammation levels were associated with a 75% reduction in risk of going on mechanical ventilation or dying. USToday

NIH to start ‘flurry’ of large studies of potential Covid-19 treatments

In an interview, NIH Director Francis Collins characterized the studies as “really well-powered, rigorously designed clinical trials.” Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines, including the Covid-19 vaccine being developed by Moderna Therapeutics. STAT

Trial for COVID-19 drug successful in helping recovery

The drug, called SNG001, uses interferon beta protein, which is already produced naturally by the body to fight infections. By inhaling additional amounts directly into the lungs, researchers said the risk of a COVID-19 infection developing into a severe disease was reduced by 79%. AA

COVID-19 vaccine hopes rise after strong trial results in England

"We are seeing good immune response in almost everybody," said Dr. Adrian Hill, director of the Jenner Institute at Oxford University. "What this vaccine does particularly well is trigger both arms of the immune system," he said. Hill said that neutralizing antibodies are produced - molecules which are key to blocking infection. In addition, the vaccine also causes a reaction in the body's T-cells which help to fight off the coronavirus. ABC 

Will Russia be the first country to produce the World’s first Experimental COVID-19 vaccine in August?

The first human trial of the vaccine was a one-month test on 38 people, which ended this week. The researchers concluded that although the strength of this response is unknown, it is safe to use and induce an immune response. According to reports, Russian scientists claimed on Monday that they hope to launch the world’s first coronavirus experimental vaccine as soon as possible next month. Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), announced that a larger trial of the third phase, including numerous thousand people, would begin in August. Inventiva 

Russian Elite Given Experimental Covid-19 Vaccine Since April

Scores of Russia’s business and political elite have been given early access to an experimental vaccine against Covid-19, according to people familiar with the effort, as the country races to be among the first to develop an inoculation. Top executives at companies including aluminum giant United Co. Rusal, as well as billionaire tycoons and government officials began getting shots developed by the state-run Gamaleya Institute in Moscow as early as April, the people said. They declined to be identified as the information isn’t public. Bloomberg 

US Drug Test Centers Launches COVID-19 Antibody Testing Nationwide

 US Drug Test Centers, one of the largest testing companies in the United States, announced they are now offering COVID-19 Antibody Testing with FDA Emergency Use Authorization at 1,800+ locations nationwide. No prescription is necessary. To book an appointment, visit www.usdrugtestcenters.com, select a location, order a test and an order from a local doctor will be sent to you in 6-12 hours. The test includes a simple blood draw, and results are received usually within 24-48 hours. Street Insighther 

Fauci really thinks a breakthrough coronavirus drug will be here by fall

It’s not just novel coronavirus vaccine candidates that are in advanced phases of human trials right now, and it’s not just COVID-19 vaccines that could be ready for emergency use before the end of the year. We’ve often talked about a new type of medicine that could work well against the new virus. On top of that, this category of drug tech can be applied to other infectious diseases to offer vaccine-like protection, though it wouldn’t be long-lasting immunity like you get with vaccines. The best part is that Dr. Anthony Fauci is already confident this new type of coronavirus drug could be available as soon as this coming fall. BGR

FDA approves Quest COVID-19 test for 'pooled' sample use

With pooling, instead of running each person’s test individually, laboratories would combine parts of samples from several people and test them together. A negative result would clear everyone in the batch. A positive result would require each sample to be individually retested. Pooling works best with lab-run tests, which take hours — not the much quicker individual tests used in clinics or doctor’s offices.ABCNews

Cholesterol-lowering meds have potential to downgrade COVID-19's threat to that of the common cold

With this information in hand, Nahmias and tenOever began to screen FDA-approved medications that interfere with the virus' ability to reproduce. In lab studies, the cholesterol-lowering drug Fenofibrate (Tricor) showed extremely promising results. By allowing lung cells to burn more fat, fenofibrate breaks the virus' grip on these cells, and prevents SARS CoV-2's ability to reproduce. In fact, within only five days of treatment, the virus almost completely disappeared. MedicalXpress 

How close are we to a vaccine for COVID-19?

An effective vaccine against the coronavirus that causes COVID-19 is everyone's hope for a real return to normal life. More than 100 teams of scientists around the world are working to develop and test a vaccine against the virus SARS-CoV-2 as quickly as possible. They're employing a huge variety of strategies and technologies, including some that have never been used in an approved vaccine before.CBCNews 

Get ready for some fantastic news about a coronavirus vaccine

“I can tell you that we now know the Oxford vaccine covers both bases – it produces both a T cell and an antibody response,” the person said. “It’s the combination of these two that will hopefully keep people safe. So far, so good. It’s an important moment. But we still have a long way to go.” BGR 

Coronavirus Drug and Treatment Tracker

Below is an updated list of 20 of the most-talked-about treatments for the coronavirus, including some of the most promising, interesting and potentially harmful. We also included a warning about a few that are just bunk. TheNewYorkTimes 

Moderna’s COVID-19 vaccine produces immune response in early trial

The interim analysis of the phase 1 study of the candidate, mRNA-1273, evaluated a two-dose vaccination schedule of the shot given 28 days apart across three dosages – 25, 100, 250 µg – in 45 healthy adults aged 18-55 years. The initial results from participants who received both doses showed mRNA-1273 produced rapid and strong immune responses against SARS-CoV-2, the virus which causes COVID-19. Despite producing a promising immune response in all patients, the vaccine also caused side effects, including mild to moderate fatigue, chills, headache and muscle pain.PMLive 

Moderna's coronavirus vaccine ready to advance to final phase of testing

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus. CBSNews 

COVID-19 vaccines are on the fast-track to approval. How will we know they're safe?

In June, the FDA issued guidelines for the approval of COVID-19 vaccines. In those guidelines, the agency described what safety evaluations a vaccine would need to pass and noted that a vaccine should show at least 50% efficacy in clinical trials, meaning that under perfect conditions, people who get the vaccine would be at least half as less likely to be infected with the coronavirus compared with unvaccinated people.   LiveScience 

The Complex Global Evolution Of Coronavirus Mask Rules

In the U.S., in just four months, state and federal government guidelines for the general public have gone from “no need for masks” to “masks are recommended” to “masks are required.” The latter applies in a growing number of states. Forbes 

Is the Race for Word's First COVID-19 Vaccine Over? Russia Announced Completion of Clinical Trials

Russia has become the first nation to complete a COVID-19 human vaccine clinical trial successfully. While initial human trial results suggest that the vaccine is safe and successful to some degree, it seems premature to announce the supposed 'first COVID-19 vaccine in the world.TechTimes 

China's CanSino in Talks for COVID-19 Vaccine Phase III Trial Overseas

Chinese vaccine developer CanSino Biologics is in talks with Russia, Brazil, Chile and Saudi Arabia to launch a Phase III trial of its experimental COVID-19 vaccine, its co-founder said on Saturday.
 China's success in driving down COVID-19 infections has made it harder to conduct large-scale vaccine trials, and so far only a few countries have agreed to work with it. The New York Times 

Lonza licenses technology to China's Junshi for experimental COVID-19 drug

Lonza said Junshi’s first neutralizing antibody against the new coronavirus was created using the Swiss company’s gene expression system, called GS Xceed. The antibody, JS016, has entered clinical trials in China, with the first healthy volunteer dosed on June 8 in an early-stage safety study. Reuters 

Gilead starts Phase I trial of inhaled version of Covid-19 drug remdesivir

The study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV. MedCityNews 

Even without a Covid-19 vaccine, there's reason for hope

Much like the vaccines that have showed early promise, these drugs too will need more testing before their safety and efficacy can be proven. But the timeline for testing these drugs is much shorter than for a vaccine, in large part due to how quickly and easily their efficacy can be determined. For antivirals and monoclonal antibodies, you know whether the virus works within a matter of days -- either the viral load in the patient goes up or it goes down -- and with very few individuals. Our first effective treatment for HIV, an antiviral, was proven in a group of just 19 patients given the drug. CNN 

EPA approves 1st disinfectant sprays that kill COVID-19 on surfaces

The Environmental Protection Agency just approved two disinfectant sprays that can kill SARS-CoV-2, the virus that causes COVID-19, on surfaces. The agency said that Lysol Disinfectant Spray and Lysol Disinfectant Max Cover Mist were effective, based on laboratory testing, in preventing the spread of the virus on surfaces.ABCNews 

Spain's coronavirus antibodies study adds evidence against herd immunity

Spain's large-scale study on the coronavirus indicates just 5% of its population has developed antibodies, strengthening evidence that a so-called herd immunity to Covid-19 is "unachievable," the medical journal the Lancet reported on Monday. CNNHealth 

13 promising Covid treatments emerging from Israel

Below we summarize 13 potential Israeli treatments using a variety of approaches – such as placenta-derived cells, peptides, blood plasma of recovered patients, and the cannabis compound CBD. There is plenty of room for more than one treatment. Israel21C

Research suggests protective effect of influenza vaccine against COVID-19 severity and mortality

A new study involving over 92,000 patients with COVID-19 in Brazil shows that the odds of severe disease, ventilatory support requirement, and death are reduced with a recent trivalent flu vaccine. This seems to indicate that these vaccines should be used as widely as possible to reduce the risk of severe COVID-19, especially among high-risk groups. NewsMedical

Oxford COVID-19 vaccine trials move to stage 3 human trials

By vaccinating volunteers with ChAdOx1 nCoV-19, scientists hope to make the human body recognize and develop an immune response (i.e., develop antibodies) to the spike glycoprotein that will help stop the SARS-CoV-2 virus from entering human cells and causing COVID-19. NewsMedical 

What is the best way to treat COVID-19? Remdesivir and plasma are promising, but other drugs are needed.

This past week, Kalil and his colleagues finished enrolling more than 1,000 patients to test the effect of combining remdesivir, an antiviral, with a pill called baricitinib, an anti-inflammatory, used to treat rheumatoid arthritis. Preliminary findings from that phase of the study are expected within the month. While researchers work to analyze those results, they will simultaneously move forward with a separate round of studies, testing the impact of remdesivir plus another medication. NBC 

How to Catch COVID-19

• You’re not likely to get it from touching a contaminated surface
• And you’re not likely to catch it from quick encounters with other people outside. (That doesn’t mean you can’t contract the virus – those activities just aren’t nearly as high of risk)
• You’re most likely to catch the virus when you talk to someone less than 6 feet away for at least 15 minutes without wearing a facemask

Here’s why: -> NBCSanDiego

Crystal Genomics to start P2 trial of Covid-19 treatment

Crystal Genomics said that the Ministry of Food and Drug Safety has given the go-ahead for conducting its phase 2 clinical trial of Camostat, a serine hydrolase inhibitor, for treating Covid-19. The trial aims to evaluate the safety and efficacy of the drug by carrying out the trial on 100 patients with mild and moderate Covid-19 symptoms. After completing enrollment, the company will divide the patients into two groups and administer either Camostat or placebo for a week. KoreaBioMedicalReviw

How doctors are innovating to treat COVID-19

One of the reasons COVID-19 presents such a significant global medical challenge is that there are few effective therapies for it so far. As cases fill hospital beds across many parts of the country, doctors and scientists are coming up with inventive ways to treat the disease, if not to cure it. Science correspondent Miles O’Brien reports. PBS

A coronavirus vaccine is still months away, but an antibody treatment could be closer

Scientists can create what are called monoclonal antibodies: lab-made antibodies created specifically to target an infection. Vaccines have the advantage of working longer than an antibody treatment. Antibody therapies potentially last a month or two and then wear off, but they can be used to temporarily protect vulnerable populations such as nursing home residents or healthcare workers or people with chronic conditions. The therapies could also treat people who are already sick with Covid-19. CNNHealth 

CanSino's COVID-19 vaccine candidate approved for military use in China

The Ad5-nCoV is one of China’s eight vaccine candidates approved for human trials at home and abroad for the respiratory disease caused by the new coronavirus. The shot also won approval for human testing in Canada. Reuters 

Cholesterol-lowering drugs help reduce COVID-19 deaths: study

After a follow-up of 28 days, researchers found that the death rate of the statin group was 5.2 percent, lower than the 9.4 percent death rate of the non-statin group. The large-scale study also showed that the use of statin drugs was associated with a decreased incidence of invasive mechanical ventilation, admission to intensive care units, and acute respiratory distress syndrome in COVID-19 patients.  CGTN

After saving his own life with a repurposed drug, a professor reviews every drug being tried against Covid-19.

Researchers working with his lab have reviewed published data on more than 150 drugs doctors around the world have to treat nearly 50,000 patients diagnosed with Covid-19. They've made their analysis public in a database called the Covid-19 Registry of Off-label & New Agents (or CORONA for short). It's a central repository of all available data in scientific journals on all the therapies used so far to curb the pandemic. This information can help doctors treat patients and tell researchers how to build clinical trials.CNNHealth 

Hospitals Experiment with COVID-19 Treatments, Balancing Hope and Evidence

Daniel Griffin, an infectious disease specialist, was standing with a group of physicians outside the doors of the intensive care unit at Plainview Hospital on Long Island, N.Y., in late February. Layered in protective gowns, masks, and gloves and standing six feet apart to maintain social distancing, the doctors swapped stories about their COVID-19 patients. Griffin brought up a disturbing trend: Many of his patients seemed on their way to recovery but then relapsed into severe respiratory distress. His colleagues had seen a similar pattern. The fluctuation of symptoms was puzzling for a virus. ScientificAmerica 

UAE and China launch Phase 3 clinical trial in humans for Covid-19 vaccine

The UAE and China collaboration is not the only vaccine at the Phase 3 stage. The University of Oxford has started a Phase 3 trial on its vaccine candidate and the US company Moderna plans to start its Phase 3 trial of 30,000 participants in July. CNNHealth 

UW joins drug trial aimed at preventing major COVID-19 killer: Haywire immune response

UW announced Wednesday that it has joined the Phase III Clinical Trial of a drug known as ruxolitinib, becoming the 32nd site to begin recruiting patients. The drug is a government-approved medication given to bone marrow transplant recipients who are in danger of suffering a cytokine storm. MilwoukeeJournal Centinel  

In early trial, an ancient drug shows promise against severe COVID-19

The medication, called colchicine, is an anti-inflammatory taken as a pill. It's long been prescribed for gout, a form of arthritis, and its history goes back centuries. The drug was first sourced from the autumn crocus flower. MedicalXpress

Trials with Oxford COVID-19 vaccine start in Brazil

Oxford University this weekend started human clinical trials for a potential coronavirus vaccine in Brazil, sponsor Lemann Foundation said in a statement late on Monday. Trials will count on 2,000 health workers volunteers in Sao Paulo and 1,000 people in Rio de Janeiro. Reuters 

Covid-19 vaccine may not work for at-risk older people, say scientists

Akbar said something else might be needed alongside the vaccine for older people, such as the steroid drug dexamethasone, which can block the inflammation caused by the virus and has been shown to save lives in Covid-19.“So for older people, you might have something like an anti-inflammatory drug, like maybe dexamethasone, together with vaccine responses to give you the maximum benefit.TheGuardian

Lilly's Covid-19 drug could be ready for use as soon as Sept, says chief scientist

Eli Lilly and Co could have a drug specifically designed to treat COVID-19 authorized for use as early as September if all goes well with either of two antibody therapies it is testing, its chief scientist told Reuters on Wednesday. Lilly is also doing preclinical studies of a third antibody treatment for the illness caused by the new coronavirus that could enter human clinical trials in the coming weeks, Chief Scientific Officer Daniel Skovronsky said in an interview.liveMint 

Cancer drug cures COVID-19 patient with acute respiratory distress

"The time between onset of ruxolitinib administration and improvement of health is so short that it is reasonable to assume that the drug ruxolitinib contributed to the favorable clinical course," Neubauer explains. Based on the success of the treatment, the German Federal Institute for Drugs and Medical Devices has approved a clinical trial that will test the effect of the administration of ruxolitinib in additional COVID-19 patients. MedicalXpress

MMR Vaccine Could Invigorate the Innate Immune System to Fight COVID-19

He advises healthcare workers, individuals in nursing homes and others at high risk of contracting COVID-19 to be vaccinated against MMR, in the hope that the innate immune response will be sufficient protection through the critical time of the pandemic, until CPVOD-19 vaccines are available. BioSpace

COVID-19 vaccines and antibodies advance even faster than expected

With large vaccine trials planned and monoclonal antibody trials underway, efficacy data could come this fall or winter. Chemical & Engineering News 

COVID-19 is weakening, could die out without vaccine, specialist claims

"In March and early April, the patterns were completely different. People were coming to the emergency department with a very difficult-to-manage illness, and they needed oxygen and ventilation; some developed pneumonia. "Now, in the past four weeks, the picture has completely changed in terms of patterns. There could be a lower viral load in the respiratory tract, probably due to a genetic mutation in the virus which has not yet been demonstrated scientifically. Also, we are now more aware of the disease and able to manage it," he said. The Jerusalem Post