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1. Assignment
on Covid 19
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Tutors India
Group www.tutorsindia.com
Email: info@tutorsindia.com

2. Introduction
Who and Clinical Trials
Eligibility
Primary and Secondary Analyses
Adaptive Design
Clinical Trials ofMrna-1273
Treatment Clinical Trials
The Adaptive Covid-19 Treatment Trial (Actt)
Immune Response to Covid-19
Investigation of Undetected Covid Cases
Conclusion
Today's Discussion

3. Introduction
Although various options for
prevention or treatment of severe
acute respiratory
coronavirus 2
syndrome
(SARS-CoV-2)
infections are available, there is no
vaccination and no medication with
established clinical effectiveness.
The research community's response
coronavirus
has been
to the pandemic of
illness 201
9 (COVID-1
9)
encouraging.

4. Clinical studies are concentrated on the COVID-19-affected countries, mainly China
and South Korea, with high-income countries in Europe and North America
preparing the majority of the next trials.
Trials are planned ina few nations such as South America and Africa. Health-care
workers will disproportionately be harmed of Covid-19 because of the lack of
protetive equipment, and sparse medical facilities.
Because all illnesses would be affected if such health-care systems were disrupted
or completely destroyed, there would be a large direct and indirect fatality rate.

6. Who and Clinical
Trials
The World Health Organization (WHO) assists in the evaluation of medications by
randomising their impact on crucial outcomes.
The national coordinator invites chosen hospitals within each country and assists
them in obtaining ethical and regulatory permission as well as study
medications, after which patient recruitment may commence.
Patient recruitment and randomization (using a cloud-based GCP-compliant
platform) as well as all other trial procedures are considerably simplified, and no
paperwork is required, allowing for collaboration even in overburdened hospitals.

7. It just takes a few minutes to electronically enter anonymised information of a few
critical features of each patient once consent has been acquired. A random
treatment allocation is created at the end of the patient enrollment process.
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The WHO will also play a key role in analysing and providing guidelines based
on the evidence collected by studies.
Despite these multinational initiatives, significant organisational and
bureaucratic barriers remain in the way of a speedy scientific response.
To overcome these obstacles, strong political backing, effective teamwork,
enough knowledge and resources, and well-informed direction will be required.

9. Adults (age 18 years) who are hospitalised with laboratory-confirmed
COVID, are not expected to be transferred within 72 hours, and have no
contraindications to any potentially relevant study medicine, according to
their clinicians.
Randomization and trial entrance.
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Eligibility

10. The patient is automatically enrolled in the trial when electronic data
collection is done, and a random allocation of their trial treatment is
created (using an algorithm that assures eventual balance in the
characteristics recently recorded between each study medication and its
controls) and shown.
Patients will be assigned to either local Standard of Care alone or local
Standard of Care plus one of the research medications at random.

11. Primary and
Secondary
Analyses
In-hospital mortality in all
patients was the focus of the
primary analysis. In-hospital
mortality was separated into
two groups based on whether
or not patients received initial
respiratory assistance.

12. Adaptive Design
The accumulated safety results and significant outcome results will be
reviewed on a regular basis by a worldwide Data and Safety Monitoring
Committee.
If evidence emerges that there are viable candidate therapies, the WHO may
suggest adding further treatment arms while the study is ongoing.
On the other hand, the WHO may opt to phase out specific treatment arms,
particularly if the Global Data and Safety Monitoring Committee determines,
based on interim assessments, that one or more of the trial treatments
definitely affects or does not influence mortality.

13. Clinical Trials of Mrna-1273
In this study, it was endeavoured to see if mRNA 1273 has any possibility of
preventing Covid-19.
The vaccine will also be tested to see whether it may prevent severe COVID-19
infection or laboratory-confirmed SARS-CoV-2 infection with or without
symptoms.
Among other things, the trial wants to know if the vaccination may prevent
COVID-19-related mortality and if just one dose can prevent symptomatic
COVID-19.

14. Treatment Clinical Trials
In this study, it was endeavoured to see if mRNA 1273 has any possibility of
preventing Covid-19.
The vaccine will also be tested to see whether it may prevent severe COVID-19
infection or laboratory-confirmed SARS-CoV-2 infection with or without
symptoms.
Among other things, the trial wants to know if the vaccination may prevent
COVID-19-related mortality and if just one dose can prevent symptomatic
COVID-19.

15. The Adaptive Covid-19Treatment
Trial (Actt)
The ACTT study compared remdesivir administered intravenously as a daily
experimental therapy versus a placebo control.
Remdesivir is a broad-spectrum antiviral therapy that is still being tested.
Remdesivir appears to hasten recovery from COVID-19, according to
preliminary findings.
The medicine, when taken orally, suppresses cytokine signalling in the body,
which is involved in inflammatory reactions.

16. Remdesivir or remdesivir plus baricitinib is given to participants in this study.
Although new study shows that hydroxychloroquine is not an effective
therapy for COVID-19 individuals hospitalised, the question of whether it is
beneficial when administered early in the course of the disease remains
unanswered.

17. Immune Response to Covid-19
To Many multinational partnership led by researchers work on inherent
immune system, as well as on its adaptibiliy with respect to severe Covid
infection.
The main objective is to find immunological and virological predictors and
correlations of clinical outcomes.

18. Investigation of Undetected
Covid Cases
Antibodies in the blood suggest that an infection has occurred previously.
Researchers will collect and analyse blood samples from up to 10,000 people
for this "serosurvey," which will give vital data for epidemiological models.

19. Conclusion
To create evidence, COVID-19 studies should be well powered. They must be
spacious and well-designed. Studies should align with the requirements of
individual nations, and also execution of the same should be simple enough.
Findings must be applicable to economically deprived , as well as flexible to
the health-care institutions and people they serve. COVID-19's negative effects
on health and welfare are anticipated to be significant in low- and middle-
income nations (LMICs).
Clinical trials and assessments of all sorts of inexpensive and implementable
interventions behavioral, organisational, medical, and supporting
interventions are a top goal.

20. Managing COVID-19 will put a lot of strain on health-care systems. Pre-
exposure prevention, post-exposure prevention, and patient care research are
all needed.
Several nations
chemoprevention
are already advocating or forbidding
or therapiesfor which there is no
the
clear
export of
proof of
effectiveness, jeopardising the trials needed to generate the evidence.
It's likely that none of the currently being tested or recommended therapy
methods will be effective. Large, well-conducted clinical studies are urgently
needed to support preventative and clinical care guidelines.

21. These trials must not take away from already overburdened health facilities,
and they must be designed to allow for remote commencement and
monitoring due to travel limitations in many regions.
There is also much that may be improved in supporting treatment and
organisation in LMIC settings to minimise COVID-19 morbidity and death, both
directly and indirectly.
Now is the time for research to help guide the increasingly tough decisions
that resource-constrained health-care systems will have to make.
Researches on Covid 19 must take in ethical consideration , legal aspectsand
logistic support to bring forth success rate.

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