Corona Virus Covid 19

citymonk

Super User
The British High Commission in India said that the decision is to help prevent the spread of variants of concern and protect the most vulnerable
Actually all west including England are angry at Indian establishment's immaturity in handling covid crisis. Politicians would be politicians, maybe even after holding high offices like that of PMs and Cms but educated Government officers should have acted wisely whole allowing election rallies and Kumbh mela while whole India was under grip of this new variant from last one month. British PM is so angry over this attitude of Indian Government that first he curtailed his India visit to two days only but now has totally cancelled his much publicised India trip.
It would be nice if wisdom prevails among indian decision makers and Maha Kumbh like gatherings are not allowed.
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
Situation is same today after 1 year also.
Beware of fake products of such huge demand products : Tocilizumab, Remdesivir etc


Story of 2020 but still relevant

Gujarat: FDCA busts racket selling spurious drug as Tocilizumab

The racket surfaced following an investigation spanning over three days, after a doctor at Sanjivini Hospital in Ahmedabad raised the alarm when one of his patients bought the spurious drug

By: Express News Service | Ahmedabad, Surat |
July 19, 2020 1:00:19 am

Tocilizumab injection, fdca, Tocilizumab injection racket, Tocilizumab injection racket busted, Tocilizumab injection illegal sale, indian express news


“We are yet to lodge an FIR as FDCA is still gathering more evidence,” said FDCA Commissioner Hemant Koshiya. (Representational)

Days after the Food and Drugs Control Administration (FDCA) busted a racket allegedly involved in black marketing of Tocilizumab injection, used for critical Covid-19 patients, the FDCA busted another racket from Surat involved in selling a spurious drug as Tocilizumab under its market name of Actemra. Five persons were detained for questioning in connection with the incident.
The racket surfaced following an investigation spanning over three days, after a doctor at Sanjivini Hospital in Ahmedabad raised the alarm when one of his patients bought the spurious drug. “The doctor got suspicious after the patient’s relative bought the drug and at the time of administering it, the doctor noticed that it was labelled as “intravascular” on the box whereas a box of Tocilizumab says “intravenous”. He sent us a photo of the same to get it verified. We contacted him and got details of where it was procured from,” FDCA Commissioner Hemant Koshiya told The Indian Express.
It emerged that the three boxes of the drug were bought from one Ashish Shah of Maa Pharmacy at Sabarmati in Ahmedabad, without any bill. Koshiya said that a mix of steroids and hormonal formulae which costs around Rs 300 was being sold as Tocilizumab for Rs 5,000. According to Koshiya, a 37-year old Surat resident, Sohel Ismail Tai, was manufacturing the spurious drug. “He was manufacturing this drug under the name of Genic Pharma and selling it at Rs 5,000,” said Koshiya.

Sources in FDCA Surat said that Tai, a resident of Sun Residency, Rander, dropped out of his computer engineering course and had started body building. “He used to purchase steroid injections from Maxtreme Pharma of Himachal Pradesh, remove its wrapper and put a new one named Genic pharma, and was selling it to one Ashish (Shah) in Ahmedabad, as steroid injections used for bodybuilding. He was also making some more steroid injections at his home used by bodybuilders,” said FDCA officials.
The officials claimed that Tai, who did not have an experience of running pharmaceutical company or a legal degree, was selling such injections to different gym owners in Surat and other parts of the state. With several other middlemen in the chain, which is under further investigation, it was traced that one Nilesh Laliwala of Happy Chemist and Protein House in Paldi, Ahmedabad, used to procure the drug from Tai, change the label to that of Tocilizumab and sell it to one Harsh Thakor, who used to sell it to Maa Pharmacy for Rs 80,000.

“We are yet to lodge an FIR as FDCA is still gathering more evidence,” said Koshiya.


Gujarat: FDCA busts racket selling spurious drug as Tocilizumab
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
New COVID-19 Vaccine May Offer Broad Protection Against Existing and Future Coronavirus Strains at a Cost of $1

TOPICS: COVID-19Infectious Diseases
Pharmaceuticals
PopularUniversity Of Virginia
Vaccine

By UNIVERSITY OF VIRGINIA HEALTH SYSTEM APRIL 19, 2021

Steven Zeichner
Steven L. Zeichner, MD, PhD, of UVA Children’s, says the vaccine could be produced very quickly, at very low cost, in existing factories around the world. The vaccine was developed using a platform Zeichner invented to speed vaccine development. Credit: Dan Addison | UVA Communications
A COVID-19 vaccine that could provide protection against existing and future strains of the COVID-19 coronavirus, and other coronaviruses, and costs about $1 a dose has shown promising results in early animal testing.
Vaccines created by UVA Health’s Steven L. Zeichner, MD, PhD, and Virginia Tech’s Xiang-Jin Meng, MD, PhD, prevented pigs from being becoming ill with a pig model coronavirus, porcine epidemic diarrhea virus (PEDV). The vaccine was developed using an innovative approach that Zeichner says might one day open the door to a universal vaccine for coronaviruses, including coronaviruses that previously threatened pandemics or perhaps even coronaviruses that cause some cases of the common cold.
Their coronavirus vaccine offers several advantages that could overcome major obstacles to global vaccination efforts. It would be easy to store and transport, even in remote areas of the world, and could be produced in mass quantities using existing vaccine-manufacturing factories.

The UVA and Virginia Tech scientists created the vaccine using a new platform Zeichner invented to rapidly develop new vaccines. So the testing success bodes well for both the COVID-19 vaccine and Zeichner’s vaccine-development approach.
“Our new platform offers a new route to rapidly produce vaccines at very low cost that can be manufactured in existing facilities around the world, which should be particularly helpful for pandemic response,” Zeichner said.
New Vaccine Approach
Zeichner’s new vaccine-production platform involves synthesizing DNA that directs the production of a piece of the virus that can instruct the immune system how to mount a protective immune response against the virus.
That DNA is inserted into another small circle of DNA called a plasmid that can reproduce within bacteria. The plasmid is then introduced into bacteria, instructing the bacteria to place pieces of proteins on their surfaces. The technique uses the common bacteria E. coli.
One major innovation is that the E. coli have had a large number of its genes deleted. Removing many of the bacteria’s genes, including genes that make up part of its exterior surface or outer membrane, appears to substantially increase the ability of the immune system to recognize and respond to the vaccine antigen placed on the surface of the bacteria.
To produce the vaccine, the bacteria expressing the vaccine antigen are simply grown in a fermenter, much like the fermenters used in common microbial industrial processes like brewing, and then killed with a low concentration of formalin.
Xiang-Jin Meng
Virginia Tech’s Xiang-Jin Meng, MD, PhD, is co-creator of the new vaccine, which has shown promising results in early testing. Credit: Virginia Tech
“Killed whole-cell vaccines are currently in widespread use to protect against deadly diseases like cholera and pertussis. Factories in many low-to-middle-income countries around the world are making hundreds of millions of doses of those vaccines per year now, for a $1 per dose or less,” Zeichner said. “It may be possible to adapt those factories to make this new vaccine. Since the technology is very similar, the cost should be similar too.”
The entire process, from identifying a potential vaccine target to producing the gene-deleted bacteria that have the vaccine antigens on their surfaces, can take place very quickly, in only two to three weeks, making the platform ideal for responding to a pandemic.
Targeting Coronavirus
Zeichner and Meng’s vaccine takes an unusual approach in that it targets a part of the spike protein of the virus, the “viral fusion peptide,” that is essentially universal among coronaviruses. The fusion peptide has not been observed to differ at all in the many genetic sequences of SARS-CoV-2, the virus that causes COVID-19, that have been obtained from thousands of patients around the world during the pandemic.
Meng and Zeichner made two vaccines, one designed to protect against COVID-19, and another designed to protect against PEDV. PEDV and the virus that causes COVID-19 are both coronaviruses, but they are distant relatives. PEDV and SARS-CoV-2, like all coronaviruses, share several of the

Amino acids are a set of organic compounds used to build proteins. There are about 500 naturally occurring known amino acids, though only 20 appear in the genetic code. Proteins consist of one or more chains of amino acids called polypeptides. The sequence of the amino acid chain causes the polypeptide to fold into a shape that is biologically active. The amino acid sequences of proteins are encoded in the genes. Nine proteinogenic amino acids are called "essential" for humans because they cannot be produced from other compounds by the human body and so must be taken in as food.
" class="glossaryLink " style="margin: 0px; padding: 0px; border-width: 0px 0px 1px; border-top-style: initial; border-right-style: initial; border-bottom-style: dotted; border-left-style: initial; border-color: initial; border-image: initial; font: inherit; vertical-align: baseline; text-decoration: none !important;">amino acids that constitute the fusion peptide. PEDV infects pigs, causing diarrhea, vomiting and high fever, and has been a large burden on pig farmers around the world. When PEDV first appeared in pig herds in the US, it killed almost 10% of US pigs – a pig pandemic.


One advantage of studying PEDV in pigs is that Meng and Zeichner could study the ability of the vaccines to offer protection against a coronavirus infection in its native host – in this case, pigs. The other models that have been used to test COVID-19 vaccines study SARS-CoV-2 in non-native hosts, such as monkeys or hamsters, or in mice that have been genetically engineered to enable them to be infected with SARS-CoV-2. Pigs are also very similar in physiology and immunology to people – they may be the closest animal models to people other than primates.

In some unexpected results, Meng and Zeichner observed that both the vaccine against PEDV and the vaccine against SARS-CoV-2 protected the pigs against illness caused by PEDV. The vaccines did not prevent infection, but they protected the pigs from developing severe symptoms, much like the observations made when primates were tested with candidate COVID-19 vaccines. The vaccines also primed the immune system of the pigs to mount a much more vigorous immune response to the infection. If both the PEDV and the COVID-19 vaccines protected the pigs against disease caused by PEDV and primed the immune system to fight the disease, it is reasonable to think that the COVID-19 vaccine would also protect people against severe COVID-19 disease, the scientists say.

Next Steps
Additional testing – including human trials – would be required before the COVID-19 vaccine could be approved by the federal Food and Drug Administration or other regulatory agencies around the world for use in people, but the collaborators are pleased by the early successes of the vaccine-development platform.

Zeichner added that he was encouraged that a collaboration between UVA and Virginia Tech, schools with a well-known sports rivalry, has produced such promising results.

“XJ is just an amazing collaborator and a wonderful scientist. And he is incredibly generous with his time and the resources he has available,” Zeichner said. “If UVA and Virginia Tech scientists can work together to try to do something positive to address the pandemic, then maybe there is some hope for collaboration and cooperation in the country at large.”

About the Research
The researchers have published their findings in the scientific journal PNAS. The findings are under peer review. The research team consisted of Denicar Lina Nascimento Fabris Maeda, Debin Tian, Hanna Yu, Nakul Dar, Vignesh Rajasekaran, Sarah Meng, Hassan Mahsoub, Harini Sooryanarain, Bo Wang, C. Lynn Heffron, Anna Hassebroek, Tanya LeRoith, Xiang-Jin Meng and Steven L. Zeichner.

Reference: “Killed whole-genome reduced-bacteria surface-expressed coronavirus fusion peptide vaccines protect against disease in a porcine model” by Denicar Lina Nascimento Fabris Maeda, Debin Tian, Hanna Yu, Nakul Dar, Vignesh Rajasekaran, Sarah Meng, Hassan M. Mahsoub, Harini Sooryanarain, Bo Wang, C. Lynn Heffron, Anna Hassebroek, Tanya LeRoith, Xiang-Jin Meng and Steven L. Zeichner, 15 April 2021, Proceedings of the National Academy of Sciences.
DOI: 10.1073/pnas.2025622118

Zeichner is the McClemore Birdsong Professor in the Departments of Pediatrics and Microbiology, Immunology and Cancer Biology, the director of the Pendleton Pediatric Infectious Disease Laboratory and part of UVA Children’s Child Health Research Center. Meng is University Distinguished Professor, and a member of Virginia Tech’s Department of Biomedical Sciences & Pathobiology.

Their vaccine-development work was supported by the Pendleton Pediatric Infectious Disease Laboratory, the McClemore Birdsong endowed chair and by generous support from the University of Virginia Manning Fund for COVID-19 Research and from the Ivy Foundation. The work was also partially supported by the Virginia-Maryland College of Veterinary Medicine (FRS#175420), and Virginia Tech internal funds (FRS#440783).



New COVID-19 Vaccine May Offer Broad Protection Against Existing and Future Coronavirus Strains at a Cost of $1
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
Covid-19: Zydus launches India's cheapest version of Remdesivir at Rs 2,800
Briti Roy Barman
13 August 2020·2-min read

New Delhi, Aug 13: Zydus Cadila on Thursday launched the cheapest generic version of Gilead Sciences' antiviral drug remdesivir in India to treat COVID-19 following reports of shortages at hospitals in the world's third-worst hit nation.
Zydus has priced it at 2,800 rupees ($37.44) per 100 mg vial. The Covid- 19 drug will be sold under the brand name Remdac to government and private hospitals treating virus infected patients, the company reported.



In a statement the company said, "The drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID patients."

"Remdac is the most affordable drug as we would like to enable patients to have access to this critical drug in the treatment of COVID 19", said Dr. Sharvil Patel, the Managing Director of Cadila Healthcare Limited."
Zydus is the fifth company to launch a copy of the antiviral in India after privately held Hetero Labs Ltd, Cipla, Mylan NV and Jubilant Life Sciences Ltd.
Officials in some Indian states had a few weeks ago complained of supply issues, but a top executive at drugmaker Cipla Ltd had earlier this week said the supplies were stabilising.
Gilead has also entered into licensing agreements with Dr.Reddy's Laboratories Ltd and Syngene International Ltd to make remdesivir for distribution in 127 countries, including India.

In June 2020, Zydus entered into a non-exclusive agreement with Gilead Sciences Inc, to manufacture and sell Remdesivir, the investigational drug, which has been issued an emergency use authorization by the U.S. Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of COVID-19.


https://in.news.yahoo.com/covid-19-zydus-launches-indias-063931970.html
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
'Not a Life-Saving Drug': ICMR Suggests Safe Use of Remdesivir in Covid-19
News18
Tue, 20 April, 2021, 3:58 pm·2-min read




The Indian Council of Medical Research (ICMR) on Tuesday shared some suggestions for rational and safe use of Remdesivir in Covid-19 as the demand for the medicine has increased for treating coronavirus patients especially in Covid-hit states including Maharashtra, Delhi, Karnataka and others. The ICMR has said that the anti-viral drug Remdesivir is “not a life-saving drug in Covid-19” and does not reduce mortality.
Remdesivir is one of the investigational drugs approved for emergency use in treating hospitalized Covid-19 patients.


Suggestion for Rational and Safe Use of Remdesivir in Covid-19 are:
– Emergency use authorisation allows Remdesivir to be used as experimental investigational drug in selected clinical condition of Covid-19.
– Remdesivir is not a life-saving drug in Covid-19; studies do not demonstrate mortality reduction with its use.
– Evidence shows that Remdesivir reduces the duration of hospital stay.
– Remdesivir should be administered in hospital setting only.
– Remdesivir is advised for hospitalised patients who are moderately sick and receiving oxygen. It is to be given for a total period of five days only and within the 10 days of illness.
– Remdesivir shout never be administered in home setting.
– Unnecessary/irrational use of Remdesivir could be harmful.
Even AIIMS Director Dr Randeep Guleria on Monday asserted that Remdesivir should only be given to patients hospitalised with moderate illness, who had a fall in oxygen saturation and have infiltrates on chest X-rays or CT-scan.
NITI Aayog member (Health) V K Paul had said that Remdesivir is not to be used in home settings and not to be procured from chemist shops. Data from studies so far have shown that Remdesivir does not have any effect in reducing the mortality in COVID-19, he said in support of Dr Guleria’s remark.
Meanwhile, social media is flooded with panic posts from family members and friends of infected patients requesting people for help in getting Remdesivir drug. If reports are to be believed, the prices of Remdesivir have doubled on the black market.
In view of the demand-supply gap, the central government has banned export of Remdesivir.


https://in.news.yahoo.com/not-life-saving-drug-icmr-102859191.html
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
Remdesivir Crunch Is Due To Bad Science, Bad Politics: Ex-president, Indian Medical Association

Many doctors are prescribing this emergency medicine even in cases it is not required as if it is a panacea for all, says former national president of Indian Medical Association.

Lola Nayar


Lola Nayar
21 April 2021

Remdesivir Crunch Is Due To Bad Science, Bad Politics: Ex-president, Indian Medical Association


File Photo



Hospitals are supposed to provide critical Covid patients with Remdesivir or Tocilizumab, two critical emergency drugs, but family members are being made to run around the city trying to latch on to the hope that one of the many helplines being circulated would provide relief.
For the fortunate family members who do manage to find the elusive injectable emergency drugs, the price is often too steep as it is being sold from Rs 10,000 to Rs 40,000 per vial, according verified reports.
The demand for oxygen cylinders has risen so much that non-Covid patients requiring it at home are finding it difficult to get supplies. Even Fabiflu, another Covid drug, for those recovering at home, has been in very short supply or even elusive for the last one week, mostly due to hoarding and black marketing, people in the medical fraternity suspect.
“Remdesivir is in great short supply mainly due to bad science and bad politics as many doctors are prescribing this emergency medicine even in cases it is not required as if it is a panacea for all,” says Dr Ravi Wankhedkar, former national president of Indian Medical Association (IMA).
Cipla’s Remdesivir is recommended at a particular stage when the patient is in the ICU and the oxygen level drops. Unfortunately, the Cipla customer helpline suggests inability to supply the drug for the next four to five days due to non-availability given the “unprecedented demand”.
Wandhedkar stresses that there is considerable misuse of the drug with a hype being created as if it is the only treatment to prevent death due to Covid when the fact is that thousands of patients have recovered without having to take this injectable drug. “Unfortunately doctors not qualified to undertake critical care treatment are advising use of this drug particularly in slum colonies and in rural areas leading to hoarding, black marketing and artificial short supply of the drug, an end result of bad policies of both the central government and the state governments,” says the medical practitioner.
In the case of Remdesivir, though efforts to ramp up production have started, it will take at least another fortnight to see improvement on ground as the processes involved are lengthy, says Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance.
“We are trying to ramp up the production from 70 million doses a month to 100 million a month by May and further to 120 million by June,” says Jain, stressing that the present shortage is due to unexpected demand, compounded most likely due to hoarding and black marketing.
In the case of Roche’s Tocilizumab, Mahesh Doshi, national president of Indian Drug Manufacturers’ Association, says the shortage is due to the fact that it has to be imported by Cipla from Switzerland. The arrangement necessitates that hospitals have to place their demand with Cipla before it imports.
Industry experts stress that the shortage is more due to mismanagement by the administrators. They cite the example of Maharashtra where the state government has issued orders that Remdesivir should be supplied directly to the hospitals. Though the directive is not being implemented effectively in many places within the state, but where district collectors are closely monitoring demand and supply to hospitals there is no shortage or black marketing of the drug.
Unfortunately, the steep rise in demand for Covid emergency drugs is seeing copycat or spurious medicines arriving in the market as indicated by arrests made in Baramati and Indore, which could be only the tip of the iceberg.
Solidarity trial conducted by WHO in 55 countries has recommended steroids and oxygen as frontline treatment for Covid. Though steroids are available, a premium is being charged for oxygen cylinders due to severe shortage. Over the last few days patients in some private hospitals have had to face difficulty due to oxygen supplies running out, relatives have reported.
While the medical fraternity is happy everyone above 18 years will have the option to get vaccinated, they feel the pace of vaccination so far is slower than the rise in the number of Covid cases.
Members of the medical fraternity feel it is unfortunate that the government focus is more on treatment rather than prevention. To ensure this there should be no red tape in giving approvals for import of vaccines and also no politics in the allotment of the vaccines across the country, stresses Wankhedkar.


Remdesivir Crunch Is Due To Bad Science, Bad Politics: Ex-president, Indian Medical Association
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
COVID-19 Treatment: What is Remdesivir and are there any substitutes for antiviral drug available in India? All you need to know

India has been hit by the second wave of COVID-19 pandemic that has led to a massive spike in daily cases. Amid the surge, a shortage of Remdesivir, an anti-viral drug used to cure COVID-19 has been reported in the country.


Updated: Tue, 20 Apr 2021 01:45 PM IST

COVID-19 Treatment: What is Remdesivir and are there any substitutes for antiviral drug available in India? All you need to know



New Delhi | Jagran News Desk:
India has been reeling under the cascading impact of the second wave of coronavirus pandemic that has led to an alarming spike in daily cases. Amid the massive surge in coronavirus cases across the country, several states and union territories (UTs) have complained of a shortage of Remdesivir, an anti-viral drug used to cure COVID-19.
The shortage has forced people to flood social media with messages about the requirement of the antiviral drug for their friends and family who have tested positive for the contagious COVID-19 infection.


What is Remdesivir?
Remdesivir is an anti-viral drug that is used in the treatment of COVID-19 patients who are in severe and critical condition.

Is this drug effective?
Though the demand for Remdesivir has increased in India amid the spike in daily cases, doctors and health experts feel that it is not a "magic solution" against COVID-19 and is not beneficial for hospitalised patients.
According to World Health Organisation's Chief Scientist Dr Soumya Swaminathan, "Based on available evidence, Remdesivir given to hospitalised patients, didn’t reduce mortality, it didn’t reduce the duration of hospitalisation and it didn’t affect the progression of the disease".

Are there any other drugs that can be used as a substitute for Remdesivir?
Meanwhile, several other antiviral drugs can be used as a substitute for Remdesivir to cure coronavirus. Following are the details about them:


FabiFlu
FabiFlu is a drug that is approved by DGCI for the treatment of COVID-19. The recommended dose of this medication is 1,800 mg dose twice on day 1, and 800 mg dose twice till day 14. This drug is used for mild coronavirus. It is the first oral Favipiravir-approved drug for the treatment of coronavirus.

What is the price of FabiFlu?
The price of FabiFlu is Rs 1,102, and it is priced at Rs 103 per tablet.

How FabiFlu works?
This drug creates an enzyme called RNA polymerase which makes more copies of SARS CoV 2 in the body, after this the virus in the body reduces and it helps to fight coronavirus.


Tocilizumab
This is an injection that is being used to treat COVID-19. This drug is used for emergency purposes when a patient faces the condition of respiratory failure.

What is the price of Tocilizumab?
This injection is available for Rs 32,480.

How does Tocilizumab work?
This drug calms the inflammatory storm in the respiratory system by blocking IL-6 receptors. This drug is generally used in severe or critical patients. A single dose of this drug should not exceed 800 mg.
Talking about the coronavirus cases, India reported more than 2.6 lakh COVID-19 cases on Sunday. On the other hand, over 1,500 fatalities were reported in the last 24 hours which has taken the death toll to 1,77,150.

Posted By: Deeksha Sharma

 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
Genentech moves Actemra into phase III COVID-19 trial

Actemra product packaging


March 19, 2020

By Cormac Sheridan


DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection. The same drug is already undergoing – or soon will be – a number of investigator-initiated trials in China and in Italy and was included in treatment guidelines issued by China’s National Health Commission on March 3. (See Clinical trials of therapeutic antibodies in COVID-19, below.)
Clinical data have yet to emerge, but the rationale for all of those studies is clear. Originally approved a decade ago for treating rheumatoid arthritis, the anti-inflammatory therapy received a new lease of life in 2017, when it gained FDA approval for treating severe or life-threatening cytokine release syndrome (CRS) in leukemia or lymphoma patients undergoing CAR T therapy.
It gained that approval, under priority review, on the basis of retrospective data on 45 pediatric and adult patients. Thirty-one attained resolution of their CRS within 14 days after receiving one or two doses of the antibody plus corticosteroids. The effect was confirmed in a further 15 patients from a separate cohort.
For COVID-19, Genentech will build a more robust evidence base. The prospective study will be placebo-controlled and will include U.S. sites, where there is most experience in treating CRS associated with CAR T. That precious knowledge – pioneered by Stephan Grupp at the Children’s Hospital of Philadelphia – should be transferable to critically ill ICU COVID-19 patients suffering life-threatening immune reactions. The study, which is due to kick off in April, is being conducted in cooperation with the U.S. Biomedical Advanced Research and Development Authority. Primary and secondary endpoints will include clinical status, mortality, mechanical ventilation and ICU variables, Genentech said.
Genentech’s move follows that of Paris-based Sanofi SA and Tarrytown, NY-based Regeneron Pharmaceuticals Inc., which unveiled plans Wednesday, March 18, to move their IL-6 inhibitor, Kevzara (sarilumab), into a phase II/III trial in patients with severe COVID-19 infection. Kevzara is approved for treating rheumatoid arthritis infection only – it gained FDA approval in May 2017 – but the present study has been informed by a trial in COVID-19 of another IL-6 inhibitor in China. IL-26, like IL-2, is implicated in CRS.
Several other antibodies have also been tested in investigator-initiated studies in China, including another Genentech product, Avastin (bevacizumab), a VEGF inhibitor long used in cancer but with no history of use in severe pneumonia. The theoretical rationale for the current studies is VEGF is a potent driver of vascular permeability – indeed, its original name was vascular permeability factor – and a major contributor to the pulmonary edema that is one of the main causes of acute respiratory distress. Elevated levels of the signaling protein have been detected in the circulation of COVID-19 patients. An open-label pilot trial is underway at present, but a larger placebo-controlled study is also planned, which should help to establish what contribution, if any, Avastin makes to patient outcomes.
Another group, led by scientists at the Fourth Military Medical University in Xi’an, China, published in BioRxiv data on meplazumab, an antibody-based CD147 inhibitor, which, they claimed, offers the SARS-CoV-2 virus an alternative entry route to cells. The virus uses angiotensin converting enzyme 2 (ACE2) as its main route into the host, but their claim that the viral spike protein – which binds ACE2 – can also interact with CD147 is controversial. The preprint, published March 14, reported in vitro data indicating that the antibody prevents viral entry to Vero E6 cells and that the SARS-CoV-2 spike protein and the CD147 receptor (also called basigin) interacted in a surface plasmon resonance assay.
Several centers in China are also trialing passive immunotherapy, using plasma-derived immunoglobulin preparations from recovered patients, a classic move in any rapidly moving outbreak.
Several newly discovered monoclonal antibodies directed against the virus itself or its receptor have been reported of late and could form the basis of drugs that could protect at-risk individuals and health care workers or that could help struggling patients to lower their viral load.
On March 12, scientists at the University of Utrecht, in the Netherlands, and other centers in the Netherlands and Germany, reported in BioRxiv that they had developed a monoclonal antibody, 47D11, which could block cellular entry of both SARS-CoV-2 and SARS-CoV, its relative that caused the first SARS outbreak in 2002-2003. The antibody, which was obtained by immunizing transgenic mice that express a chimeric antibody repertoire comprising human variable heavy and light chains and rat constant regions, binds a shared epitope on the binding domain of the spike protein on each virus. It could form the basis of both serological tests and a therapeutic antibody. Earlier this week, scientists at the Flanders Institute of Biotechnology and the University of Ghent in Belgium, and collaborators at the University of Texas, Austin, and the German Primate Center, Leibniz Institute for Primate Research in Göttingen, Germany, reported on an antibody that can neutralize a lab variant of the SARS-CoV-2 virus. Both reports represent the starting point of what would be a long campaign to realize an actual antibody drug.

(Chart to be seen in Browser for Table- Not compatible in Tapatalk etc.)

Clinical trials of therapeutic antibodies in COVID-19 infection :

DrugDeveloperMechanismTrial sponsorNumber of patients
Actemra (tocilizumab)Genentech Inc., South San FranciscoInterleukin-6 (IL-6) receptor inhibitorGenentech330
Avigan (favipiravir) + tocilizumabFujifilm Holdings Corp., Tokyo; Genentech Inc.Viral RNA polymerase inhibitor + IL-6 inhibitorPeking University First Hospital, Beijing, China150
Tocilizumab vs. Continuous replacement renal therapyGenentech Inc. (tocilizumab only)IL-6 receptor inhibitor vs. extracorporeal blood purificationTongji Hospital, China120
TocilizumabGenentech Inc.IL-6 receptor inhibitorUniversità Politecnica delle Marche, Ancona, Italy30
Kevzara (sarilumab)Sanofi SA, Paris; Regeneron Pharmaceuticals Inc., Tarrytown, N.Y.IL-2 inhibitorSanofi, Regeneron400
Avastin (bevacizumab)Genentech Inc.Vascular endothelial growth factor (VEGF) inhibitorQilu Hospital of Shandong University, Shandong, China118
Avastin (bevacizumab)Genentech Inc.Vascular endothelial growth factor (VEGF) inhibitorQilu Hospital of Shandong University20 (pilot study)
Intravenous immunoglobulin therapyNot applicable (NA)Antibodies isolated from plasma of patients who have recovered from COVID-19 infectionPeking Union Medical College Hospital80
Intravenous immunoglobulin therapyNAAntibodies isolated from plasma of patients who have recovered from COVID-19 infectionWuhan Union Hospital, Wuhan, China10
Intravenous immunoglobulin therapyNot applicable (NA)Antibodies isolated from plasma of patients who have recovered from COVID-19 infectionShanghai Public Health Clinical Center, Shanghai, China15
Soliris (eculizumab)Alexion Pharmaceuticals Inc., New Haven, Conn.Complement inhibitorHudson Medical, New YorkIndividual patients under IND
Humanized meplazumabJiangsu Pacific Meinuoke Biopharmaceutical Co., Changzhou, ChinaCD147 inhibitorTang Du Hospital, Xi’an, China20

Sources: Company websites; ClinicalTrials.gov


Genentech moves Actemra into phase III COVID-19 trial
 

adsatinder

Plz Help Himabuj (Amit Tyagi) in Corona Fighting
United Airlines Crew Refuses To Undergo Covid Test At Delhi Airport, Returns To New York In Empty Flight

"Due to the updated Covid regulations set forth by the Indian government, we had to cancel some flights and others are delayed," United Airlines wrote on Twitter.

By: ABP News Bureau
Updated: 24 April 2021, 5:38 PM (IST)

File Photo


File Photo


New Delhi: In a strange occurrence, a United Airlines flight which was to take passengers from national capital Delhi to New York City returned from Delhi Airport without any passengers.
The flight returned with no passengers after the United Crew refused to undergo a mandatory RT-PCR test at the Delhi Airport, as reported by News18. United Airlines has also cancelled all Delhi flights until further notice.


“As we seek clarity regarding Covid-19 travel requirements to India, we have temporarily suspended service to DEL for April 22 and canceled the corresponding return flights. We are working to provide alternate options to our customers and plan to resume our scheduled service as soon as possible,” - United Airlines Spokesperson said.
“United Airlines is scheduled to resume flights from Delhi to the United States from Sunday 25 April,” the Spokesperson added.
The airline has been responding to queries raised by several Indian passengers regarding their flights.
One of the responses read: “Due to the updated Covid regulations set forth by the Indian government, we had to cancel some flights and others are delayed. We are in talks with them to see if we can resolve some issues but this is not guaranteed. Right now, flights are day-to-day so we encourage you to stay updated with your flights online until a decision is made. We do not have any further information at this time”.






As India witnesses a second wave of Coronavirus pandemic, the crew of quick turnaround flights with no exit from the aircraft have been exempted from the RT-PCR test. However, flights wherein crew deboard the plane have to undergo the Covid test.
In the case of United Airlines, the flight landed in Delhi with passengers on board and was supposed to leave later, which means the crew would have to deboard the plane and exit the airport.

United Airlines Crew Refuses To Undergo Covid Test At Delhi Airport, Returns To New York In Empty Flight
 
Top