medicine vaccine on covid19- part 1

medicine vaccine on covid19- part 1

1.     Stem cell therapy in patients infected with COVID-19 by Australia’s Mesoblast plans :

Australian stem cell therapy company Mesoblast Ltd. Is working on plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) and the process is at earlier to 2^nd stage, as per their Videos conferencing.  It is further elaborated that it is acute respiratory distress syndrome, which is the body’s immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs. It is working on an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus and at the same time, it should not harm lungs.

It is mentioned that :

a) In an  analyses, of a 60-patient randomized controlled study in chronic obstructive pulmonary disease (COPD), remestemcel-L infusions were well-tolerated, significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in those patients with elevated inflammatory biomarkers.

b) Since the same inflammatory biomarkers are also elevated in COVID-19, those data suggest that remestemcel-L could be useful in the treatment of patients with ARDS due to COVID-19.

1.    01.05.2020 : US government has granted permission to its hospitals to use Remdevisir to cure patients suffering from COVID-19.

Gilead Science's Remdivisir is also touted to be a possible cure for the COVID-19. However, there is minimal data over it and better trials are needed as there are only a handful of trials done as of now, as per accounts from the US where it has been permitted by the CDC. The US government has granted permission to its hospitals to use Remdevisir to cure patients suffering from COVID-19.

2.       05 05 2020 : Israel Defence Minister Claims Breakthrough In Developing Covid-19  Antibody.

Bennett visited the labs of the Israel Institute for Biological Research (IIBR), a secretive unit that works under the Prime Minister’s Office, in Ness Ziona and was shown the “antibody that attacks the virus in a monoclonal way and can neutralize it within the bodies of those ill,” according to the statement from his office.

Bennett visited the labs of the Israel Institute for Biological Research (IIBR), a secretive unit that works under the Prime Minister’s Office, in Ness Ziona and was shown the “antibody that attacks the virus in a monoclonal way and can neutralize it within t

1. GILEAD SCIENCES: Remdesivir

Type: Drug. Status: Repurposed experimental. Early results: 0-3 Months.

Antiviral drug, originally developed to combat RNA viruses including respiratory syncytial virus. At least 13 trials underway in China, Europe and the United States with preliminary results from two Chinese trials expected as soon as April 2020. A February assessment by the WHO flagged this candidate as the most promising for battling COVID-19.

Caveats

Initial data are expected to come from studies of patients with relatively severe COVID-19. Because antivirals work best when patients are healthier, those results may show limited effectiveness.

2. Hydroxychloroquine / chloroquine

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Malaria drug also believed to have antiviral activity. Blocked SARS-CoV-2 entry into cells in an in-vitro experiment. In one small French study, some COVID-19 patients showed improvements but there was no way to know if the drug was the reason. Results published in April from another study in France and one in China found no benefit in patients treated with the drug. Dozens more clinical studies are underway around the world.

3. ROCHE: Actemra (tocilizumab)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Monoclonal antibody approved for rheumatoid arthritis and also for treating the "cytokine storm" immune overresponse in cancer patients. Fifteen registered trials in China, Europe and the United States are testing it on COVID-19 patients, alone or in comparison to other therapies. One French trial is looking at 28-day effects on COVID-19 in patients with advanced or metastatic cancer.

4. SANOFI, REGENERON PHARMACEUTICALS: Kevzara (sarilumab)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Monoclonal antibody approved for inflammatory arthritis, and in trials targeting the "cytokine storm" immune response in severely ill COVID-19 patients. Regeneron's chief scientific officer has said initial data on effectiveness could come by late April.

5. NOVARTIS, INCYTE: Jakavi (ruxolitinib)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Developed to treat inflammatory and autoimmune diseases, and in late-stage development as a cream for atopic dermatitis. One trial each in Canada and Mexico will test the drug in COVID-19 patients with severe respiratory symptoms associated with the "cytokine storm" immune response, with preliminary results expected by June 2020. In the United States, Novartis established a managed access program for use in severe/very severe COVID-19 illness on April 7.

6. MODERNA/NIAID: mRNA 1273

Type: Vaccine. Status: Experimental. Early results: 0-3 Months.

RNA vaccine made with messenger-RNA (mRNA) encoding the spike protein of SARS-CoV-2 encapsulated in a lipid nanoparticle. The phase 1 trial with 45 subjects aged 18-55 at three locations in the United States will evaluate the vaccine's safety and provide early data on the immune response it induces. Trial completion is anticipated to be June 1, 2020.

7. Convalescent plasma

Type: Non-drug therapy. Early results: 0-3 Months.

Blood plasma from recovered COVID-19 patients is transfused into patients who are currently ill, in the hope the freshly-made antibodies it contains will help fight the virus. The method has been used for more than 100 years and carries little risk of harm or side effects. Small case studies suggest it may help reduce virus levels, and controlled trials are in progress in China, Europe and the United States to gather stronger evidence for a benefit. Results published in April from a study in 10 patients with severe illness in China found significant improvement compared to similar patients who did not receive the treatment.

Caveats

Immediately available and already in limited use, but supply of plasma from recovered patients may not be sufficient to meet all needs. Further studies of recovered patients must also determine if everyone produces a full immune response to the infection, including "neutralizing antibodies," at sufficiently high levels to become donors.

8. ABBVIE: Kaletra (lopinavir/ritonavir)

Type: Drug. Status: Repurposed. Early results: 0-3 Months.

Antiviral combination used to treat and prevent HIV infections. More than twenty trials around the world are testing the drug as a COVID-19 treatment or post-exposure prophylaxis for people with high-risk close contact with a confirmed case. Initial results expected as soon as May 2020.

Caveats

One randomized controlled trial in China published results in March showing no differences in viral load or 28-day mortality among 199 patients. Median time to clinical improvement was one day shorter in patients taking the drug. However the same investigators, doctors at Jinyintan Hospital in Wuhan, said in April that they believe Kaletra, as well as a second drug, bismuth potassium citrate, helped some of the COVID-19 patients they treated.

9. CHONGQING PUBLIC HEALTH MEDICAL CENTER, CHONGQING SIDEMU BIOTECHNOLOGY TECHNOLOGY CO.,LTD: NKG2D-ACE2 CAR-NK cells

Type: Non-drug therapy. Status: Experimental. Early results: 0-3 Months.

NKG2D receptor for the immune system's natural killer (NK) cells paired with the ACE-2 receptor that the coronavirus uses to enter human cells. A multicenter Phase 1/2 trial in 90 patients is testing whether this cell therapy can prevent the SARS-CoV-2 virus from entering cells and multiplying, and will look at efficacy over 28 days in patients with severe or critical COVID-19 pneumonia.

10. NOVAVAX: NVX-CoV2373

Type: Vaccine. Status: Experimental. Early results: 0-3 Months.

Novavax said its Matrix-M adjuvant would be used with the vaccine candidate - NVX-CoV2373 - to enhance immune responses. Trials in 130 adults is expected to begin in mid-May with preliminary immunogenicity and safety results in July, according to the company.

Caveats

Strong immunogenicity in animal tests, but might require two doses in humans, which would limit supply.

11. APEIRON BIOLOGICS: RhACE2 APN01

Type: Drug. Status: Experimental. Early results: 3-6 Months.

A recombinant human angiotensin converting enzyme 2 (rhACE2) under Phase-2 clinical development in ALI (Acute Lung Injury) and PAH (Pulmonal arterial hypertension). This synthetic version of the human protein that the novel coronavirus uses to enter cells is being tested in Austria to see if it can block viral entry and decrease viral replication in COVID-19 patients, reducing deaths or need for mechanical ventilation. Preliminary results from the trial that was announced on April 2 are expected in September 2020.

12. SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE: Lentiviral Minigene Vaccines (LV-SMENP)

Type: Vaccine. Status: Experimental. Early results: 3-6 Months.

Engineered minigenes encoding viral antigens; lentiviral vector designed to infect dendritic and T cells to induce immunity. The trial in 100 adults in Shenzen, China, is expected to be complete by July 31, 2020.

13. MURDOCH CHILDREN'S RESEARCH INSTITUTE; UMC UTRECHT: BCG tuberculosis vaccine

Type: Vaccine. Status: Repurposed. Early results: 3-6 Months.

Bacillus Calmette-Guérin tuberculosis vaccine that induces a broad innate immune-system response, which has been shown to protect against infection or severe illness with other respiratory pathogens. Large trials in Australia and the Netherlands are testing whether using BCG to rev-up immune defenses in health workers and the elderly reduces unplanned absenteeism, respiratory illnesses including COVID-19, severe illnesses and deaths. Two additional trials by the Max Planck Institute in Germany of a TB vaccine candidate, VPM1002, are in the works.

14. INOVIO PHARMACEUTICALS, COALITION FOR EPIDEMIC PREPAREDNESS INNOVATIONS (CEPI): INO-4800

Type: Vaccine. Status: Experimental. Early results: 3-6 Months.

DNA plasmid vaccine delivered into the skin via a patch-style electroporation device. A clinical trial launched on April 3 could yield preliminary data by late summer, according to the company, which has said it can manufacture 1 million doses by year-end for additional trials and emergency use.

15. UNIVERSITY OF AARHUS, DENMARK: Camostat mesylate

Type: Drug. Status: Repurposed. Early results: 6-12 Months.

Protease inhibitor licensed in Japan and South Korea to treat chronic pancreatitis. In vitro experiments found it blocks a mechanism SARS-Cov-2 uses to enter human cells. As of early April, an estimated 180 COVID-19 patients aged 18-110 were being recruited at nine locations in Denmark for a phase 2a trial that will examine 30-day changes in disease severity and mortality, with results expected by December 2020. The University of Tokyo also announced plans for a trial of camostat mesylate and a related drug, nafamostat mesylate, starting as early as April 2020.

16. INFLARX: IFX-1

Type: Drug. Status: Experimental. Early results: 6-12 Months.

Monoclonal antibody targeting complement activation product C5a. Designed to block a mechanism of inflammation, the drug is also in clinical trials for Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum. In early April, a trial in the Netherlands launched to test IFX-1 in patients with severe COVID-19 pneumonia, with preliminary results expected in late October 2020.

17. CANSINO BIOLOGICAL INC./BEIJING INSTITUTE OF BIOTECHNOLOGY: AD5-nCov

Type: Vaccine. Status: Experimental. Early results: 6-12 Months.

Non-replicating viral vector. A single-center phase 1 trial with 108 subjects aged 18-60 in Wuhan, Hubei, China, started in March to test the safety and immune responses generated by a recombinant vaccine that uses another respiratory virus, adenovirus, as a vector. On April 12, a randomized controlled phase 2 trial with 500 participants launched to test varying doses against placebo. Phase 1 completion is in late December 2020, and phase 2 results are expected in January 2021.

18. IMPERIAL COLLEGE LONDON: Aspirin, Clopidogrel, Rivaroxaban, Atorvastatin, Omeprazole

Type: Drug. Early results: 9-12 Months.

Trial of cardioprotective drugs to prevent direct damage to the heart muscle that appears to drive the severity of COVID-19 in certain patients as well as their likelihood of needing invasive critical care. The trial will include more than 3,000 patients in the United Kingdom, with a completion date of March 30, 2021.

19. UNIVERSITY OF OXFORD: ChAdOx1

Type: Vaccine. Status: Experimental. Early results: 12-18 Months.

Non-replicating chimpanzee adenovirus vector. Phase 1/2 trial with 510 subjects aged 18-55 at four centers in the United Kingdom. The trial will test safety and immunogenicity of one or two doses of the vaccine, and is expected to be completed in May 2021.

20. Serology / Antibody Testing

Type: Testing. Status: Experimental. Early results: 0-12 Months.

Governments and academic groups have started to test blood for antibodies indicating that a person has been exposed to the new virus, with or without showing symptoms. The presence of antibodies indicates past infection, but separate, ongoing research is needed to know what type and concentration of virus-neutralizing antibodies protect against a new infection, whether all infections produce a full antibody response, and how long protection might last.

Wide serology testing for antibodies will soon provide a broader understanding of the scope and dynamics of the pandemic, help identify which recovered patients may have some immunity to reinfection and for how long, and also help identify the neutralizing antibodies that could become templates for monoclonal antibody therapies as well as models for desired responses from a vaccine candidate. Data from serology testing are expected to begin appearing within weeks.

Caveats

Early data on COVID-19 patients in China suggests that most develop varying amounts of antibodies in response to infection. One pre-publication report analyzed plasma from 175 patients and found that a sign of inflammation correlated with higher antibody titers and that younger patients were less likely to produce large amounts of antibodies.

Experts think instances of "reinfection" in recovered patients are more likely relapses in patients whose bodies had not cleared the virus. Data is still lacking on whether mild or symptomless infections generate meaningful antibody responses or protection.

Sharehe bodies of those ill,” according to the statement from his office.

Covid-19 vaccine Covaxin

With the rising number of novel coronavirus cases increasing at a pace of daily highs in the country for the past few days, India's first indigenous Covid-19 vaccine Covaxin got a nod from the AIIMS Ethics Committee on Saturday to start human trials from Monday 20-JUL-2020.

AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. In phase I, the vaccine would be tested on 375 volunteers and a maximum of 100 of them would be from AIIMS and as other States may be offered to.

Moreover, human dosing of the vaccine developed by Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV) also started on Wednesday, with the vaccine being given to participants at All India Institute of Medical Sciences, Patna and Pandit Bhagwat Dayal Post Graduate Institute of Medical Sciences (PGIMS) at Rohtak in Haryana, as per Sources.

The biotech company had got the approval for human clinical trials from the Drugs Controller General of India (DCGI) earlier this month.

The major updates that we know about India's first indigenous COVID-19 vaccine :

1)      The AIIMS Ethics Committee gave its approval for a human clinical trial to begin from tomorrow. "Healthy volunteers having no co-morbid conditions and without a history of Covid-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial.

2)  The human trials of Covaxin has begun at the All India Institute of Medical Sciences, Patna. AIIMS-Patna chose 10 volunteers to start the human trial of Covaxin.

3)   AIIMS Patna was the first institute to start the trial on Wednesday and has so far vaccinated around nine people with a smaller dose to check for safety, two sources said, on condition of anonymity. After two weeks, if the vaccine is found to be safe it will be given to more people, the sources said.

4)   he trials have so far started in AIIMS, Patna, and some more sites. Earlier, Haryana’s health minister Anil Vij tweeted that human trial with Bharat Biotech’s coronavirus vaccine ‘Covaxin’ started at PGIMS Rohtak as well.    All have tolerated the vaccine very well. There were no adverse efforts.

5)  The human clinical trials for Covaxin had been initiated across the country with 375 volunteers, sources from Bharat Biotech said on Friday 19-JUL-2020.   Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated" vaccine at its high-containment facility at Genome Valley in Hyderabad.

   Russia coronavirus vaccine trials end today 19-JUL-2020, targets launch next month:

   Researches are widely stressing on the fact that the vaccine is both safe and reliable 

     A research institute head said the vaccine will give people protection against the virus for a period of over two years

Plasma therapy works

  Plasma therapy or convalescent plasma has proven effective in reducing the severity or mortality of corona infection. In such immunoglobulin therapy, the liquid portion of the blood that has antibodies from recovered patients is given to patients with severe COVID-19. Although plasma therapy may help accelerate recovery, limited donor availability may limit the widespread use of the convalescent plasma.