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 2nd 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.
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.
