Clinical trials
registered in India for treatment of COVID19
COVID-19
or also known as coronavirus disease is an infectious disease that
was first identified in Wuhan, China, in December 2019. It has spread among
patients that presented with a new form of viral pneumonia with the shared
history of visiting the Huanan seafood market (1) COVID-19 is now causing a
pandemic because of the rapid spread of disease worldwide primarily through
human to human transmission. The main reason for the spread of disease is the
long incubation period for COVID-19 i.e. it takes about 2 weeks for the
symptoms to develop and thus identified. In that period, the infected person
can transmit this disease to countless other people they come in contact with
through cough or sneeze droplets. Another reason for its danger lies in the survival
of viruses causing disease. COVID-19 is caused by the SARS-CoV-2 virus and this
virus can remain viable and infectious in aerosols for hours and on surfaces up
to days. (2). Currently, intensive care unit ad ventilation is used
for complication including pneumonia and COVID-19 cases. A recent method for
treatment includes screening/ usage of existing broad-spectrum antiviral drugs,
screening of chemical library/ databases and re-development of new drugs base
on the new genome and biophysical study of virus.(3)
The exact mechanism for this disease is yet not known and is still under
research but there are several theories proposed. The pandemic is the risk to
global health with more than 28 lakh confirmed cases and more than 1,98000
deaths globally by WHO. Data as of 27th April 2020 (4)
And more cases are emerging has ignited the various countries to develop a
vaccine, treatment or supportive care for COVID-19 pandemic.
Many countries
have officially ordered lockdown while others have recommended self-quarantined.
In developing countries like India with severe deficiency Of Healthcare resources,
this has led to disruptions of regular outpatients, inpatients, critical care,
and emergency services. In the deficiency of healthcare resources, the Paediatric
population has been most severely affected as a regular visit for immunization
and for common fever, vomiting has been halted countrywide. This situation has
led to an increase in complications of the non-COVID-19 disease as reported
from various sources. In this correspondence, an objective scoring system is
proposed recently. (Outbreak of Respiratory Tract Infection scale-ORTIS).
In the view of an exponential
rise in COVID-19 in India, there are several clinical studies going on in
India. The studies have been designed to collect and analyze the data of
healthcare workers and in the general population
Clinical
trial
|
Sponsor
|
Brief
about trial
|
|
1.
|
Max
COVID-19 Study.
|
Max
healthcare institute limited, Delhi
|
To
identify individuals with flu-like symptoms in suspicion of COVID-19 and
follow them up to 8 weeks until pandemic resolves
|
2.
|
Efficacy
of convalescent plasma therapy in severely sick COVID-19 patients- Phase2 NCT04346446
|
Institute
of Liver and biliary sciences
|
To
identify individuals receiving convalescent plasma for the benefit and
adverse events.
|
3.
|
The
spectrum and profile of COVID-19 infections and its impact on its liver NCT04345640
|
Institute
of the liver and biliary sciences
|
To
address the clinical presentation, biochemical alteration, and outcomes of COVID-19
infections in subjects with pre-existing liver disease in comparison to those
having infections in the absence of pre-existing liver disease.
|
4.
|
A
clinical trial of Mycobacterium w in critically ill COVID-19 patients - NCT04347174
|
Cadila
pharmaceuticals
|
To
evaluate the safety and efficacy of Mycobacterium w in combination with
standard care as per hospital practice versus standard care alone in
critically ill adult patients suffering from COVID-19 infection.
|
5.
|
Command
hospital Airforce, Bangalore
|
Chloroquine
has been demonstrated to have and anti-SARS CoV2 activity in vitro and has
shown a significant reduction in Viral load. This has to compare with the control
group (Not receiving chloroquine) (500mg)
|
|
6.
|
Hydroxychloroquine,
an open-labeled, Randomised intervention for prevention of new infection and
adverse outcomes following COVID-19 Infection- A tertiary Hospital-based
study (Phase 3) CTRI/2020/03/024402
|
Aster
Malabar Institute Of Medical Sciences (MIMS), Kozhikode, Kerala
|
It
is a randomised, open-labeled study which compares two dosing regimens of
hydroxychloroquine sulfate for prophylaxis against COVID-19
1.Hydroxychloroquine
(HCQ)- ICMR regimenè400mg bd for one
day followed by 400 mg weekly for 7 weeks to be taken with meals.
2.
intervention dose è 300mg daily for
7 days followed by 300mg weekly for 7 weeks
|
7.
|
Outbreak
of Respiratory Tract Infection Score (ORITS): Objective Screening for
Children to rule out COVID-19 and prevent nosocomial spread
|
Dr.
Atul Child hospital Main Shastri Nagar Road, Jaipur, Rajasthan. (Private
Hospital)
|
Visit
the link for a detailed description of the study .
|
8.
|
An
open-labeled trial to evaluate the safety and efficacy of SSV formulation to boost
immunity in quarantine patients of COVID19 CTRI/2020/04/024659
|
Department
of Medicine, Niphad Sub-district Hospital, Niphad, Maharashtra
|
To
evaluate the role of SSV formulation to boost immunity in quarantined patients
of COVID-19 as judged by the improvement in signs such as axillary temperature,
respiratory rate, pulse and blood pressure, etc. and clinical variables such including
pro-inflammatory cytokines TNF-alpha and IL-6
|
Besides these clinical trials on supportive care
of COVID19, there are some trials registered on Vaccine formulation worldwide
and everyone is working towards the best combination of existing antiviral and HIV
drugs such as Remdesivir, Lopinavir, Ritonavir, ribavirin, penciclovir,
nitazoxanide, nafamostat, fapinavir. Several recombinant proteins may also have
the potential for diagnosis, prophylaxis and treatment for COVID19. Disulfiram
could also inhibit the papain-like proteases of MERS and SARS in cell cultures.(3)
There are several major gaps in our current
knowledge of the origin, epidemiology, duration of disease, human transmission
of the virus and clinical spectrum of disease, which could be fulfilled by more
studies.
References:
1. Peeri,
N. C., Shrestha, N., Rahman, M. S., Zaki, R., Tan, Z., Bibi, S., … Haque, U.
(2020). The SARS, MERS, and novel coronavirus (COVID-19) epidemics, the newest
and biggest global health threats: what lessons have we learned? International
Journal of Epidemiology, 1–10. https://doi.org/10.1093/ije/dyaa033
3. Mali, S. N. (2020). The Rise of New
Coronavirus Infection-(COVID-19): A Recent Update. Eurasian Journal of
Medicine and Oncology, (March). https://doi.org/10.14744/ejmo.2020.22222
4. Culp, W. C. (2020). Coronavirus
Disease 2019. A & A Practice, 14(6), e01218.
https://doi.org/10.1213/xaa.0000000000001218
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