India’s Authorities Approve Start of WHO Solidarity Trial in Gujarat India & Challenges at GMERs

May 6, 2020 | Challenged Sites, Gujarat Medical & Education Research Society, India, News, Site Challenges, Site Watch, SOLIDARITY Trial, World Health Organization

India’s Authorities Approve Start of WHO Solidarity Trial in Gujarat India & Challenges at GMERs

The World Health Organization’s Solidarity Trial covering COVID-19 launches in Gujarat India at sites including SVP College in Ahmedabad, GMERs, Vadodara; New Civil Hospital, Surat and PDU Medical College, Rajkot. The study will also be conducted at B.J. Medical College in Ahmedabad. The trial is being conducted in association with the Indian Council of Medical Research as recently announced by Principal Secretary of Health Jayanti Ravi

COVID-19 Pandemic in Gujarat

The virus’ growth has accelerated in the state of Gujarat as the COVID-19 death toll has crossed the 300-figure mark now at 319, according to The Week. On the western coast of India, Gujarat primarily lies on the Kathiawar peninsula and is home to about 60.4 million people making it the ninth largest state by population.

The Study

WHO’s Solidarity Trial received a lot of interest within the TrialSite News viewer base. As reported, the trial covers the following therapies:

Remdesivir: The new coronavirus is giving this compound a second chance to shine. Originally developed by Gilead to combat Ebola and related viruses, remdesivir shuts down viral replication by inhibiting a key viral enzyme, the RNA-dependent RNA polymerase. TrialSite News recently covered a story of a CA woman whose condition was improved with Remdesivir.  

Chloroquine and hydroxychloroquine: The WHO scientific panel designing SOLIDARITY had originally decided to leave the duo out of the trial, but had a change of heart at a meeting in Geneva on 13 March, because the drugs “received significant attention” in many countries, according to the report of a WHO working group that looked into the drugs’ potential. The widespread interested prompted “the need to examine emerging evidence to inform a decision on its potential role.”

Ritonavir/lopinavir: This combination drug, sold under the brand name Kaletra, was approved in the US in 2000 to treat HIV infections. Abbott Laboratories developed lopinavir specifically to inhibit the protease of HIV, an important enzyme that cleaves a long protein chain into peptides during the assembly of new viruses. Because lopinavir is quickly broken down in the human body by our own proteases, it is given with low levels of ritonavir, another protease inhibitor, that lets lopinavir persist longer. The combination can inhibit the protease of other viruses as well, specifically coronaviruses. It has shown efficacy in marmosets infected with the MERS virus, and has also been tested in SARS and MERS patients, though results from those trials are ambiguous.

Site Locations

According to this recent news report, the study will be conducted at SVP College in Ahmedabad, GMERs (Vadodara), New Civil Hospital, Surat and PDU Medical College.

SVP Hospital in Ahmedabad inked a memorandum of understanding with the Indian Council of Medical research making the Gujarat-based provider the first health facility in India to be selected for a major study there involving convalescent plasma. Apparently, the New Civil Hospital has been converted into a major hub for COVID-19 patients.

Problems in “Dedicated COVID-19 Hospital”

Based in Vadodara, GMERS or the Gujarat Medical & Education Research Society was commissioned in 1969 and now has 300 beds—it is know for its focus on working under as “holistic healthcare services, preventive, promotive, curative and rehabilitative-under the allopathic system.” Although it is a district hospital, according to its website its serves more like a general hospital meeting the primary, secondary and select tertiary healthcare needs of the area.

Problems have been reported at GMERS, where purported video shots went viral; suspected COVID-19 patients apparently made complaints about lack of cleanliness and inappropriate response from medical staffers. The local health district, taking these allegations seriously, issued warnings to all concerned departments, reported India Express.

After an officer filed a complaint on behalf of the patients, a committee led by a deputy commissioner rank official, organized an inquiry into the matter. A somewhat telling statement in a letter based on its findings says: “Take cognizance of the fact that there has been complete negligence on the part of the concerned departments and contractors in addressing the issues, we want that all the issues be resolved at the earliest. If the issues are not resolved, necessary actions under the Epidemic Disaster Act, 1897, and relevant sections of the Indian Penal Code, will be taken.”

Source: TheWeek

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