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Steroid treatment should be reserved for sickest COVID-19 patients, say scientists

Washington: Most adults with moderate-to-severe COVID-19 have a suppressed immune response against the novel coronavirus rather than life-threatening hyper-inflammation, according to a study which suggests steroids such as dexamethasone should be reserved for the sickest patients.

Scientists, including those from St. Jude Children’s Research Hospital in the US, assessed the levels of the immune system protein cytokines, and other health markers in 168 adults with COVID-19, 26 adults with flu and 16 healthy volunteers.

They said more than 90 per cent of the COVID-19 patients were hospitalised, and about half in the intensive care unit (ICU), while more than half of flu patients were admitted for treatment, and 35 per cent were in the ICU.

According to the research, published in the journal Science Advances, fewer than 5 per cent of the COVID-19 patients, including some of the sickest inpiduals, had the life-threatening, hyperinflammatory immune response known as the cytokine storm syndrome.

The researchers explained that cytokine storms develop when excess or abnormally regulated levels of cytokine proteins in the body lead to hyperinflammation and tissue damage.

While dexamethasone and other steroids are prescribed to treat cytokine storms, they said these drugs can backfire in patients whose immune response is already suppressed.

“We did identify a subset of COVID-19 patients with the broadly upregulated array of cytokines. But, overall, the average person with COVID-19 had less inflammation than the average person with flu,” said study co-author Paul Thomas from St. Jude Children’s Research Hospital.

Based on the findings, the scientists said treatment suppressing inflammation might only be effective in a minority of patients with the hyperinflammatory profile.

They believe the need of the hour is a fast, reliable, and inexpensive test to measure cytokines and identify patients who are most likely to benefit from dexamethasone treatment.

“Directing immunosuppressive therapies to the small subset of COVID-19 patients who have an overactive immune response is the only way to know if these approaches are ultimately helpful,” said Philip Mudd, another co-author of the study from the Washington University School of Medicine in the US.

‘Indiscriminate use of remdesivir, tocilizumab on COVID patients can cause more harm than good’

NEW DELHI: The Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS) have asked states to use drugs like remdesivir and tocilizumab, mentioned as investigational therapies, on COVID-19 patients strictly as per the laid down protocol as their “indiscriminate use or use in conditions for which they are not desirable may cause more harm than good”.

In a video conference with the states on Friday, the two bodies stressed that the treatment approach for COVID-19 is largely based on supportive care since there is no cure as yet, the health ministry said in a statement on Saturday.

They told the states that the drugs mentioned as ‘investigational therapies’ should be used with caution due to their potential for serious adverse effects including liver and kidney injury, the health ministry said.

During the conference on ˜COVID Case Management by State/UT Centres of Excellence’, states were also told that the available evidence for remdesivir suggests that it may decrease the time for clinical improvement when used in moderate to severe cases. However, there have been no benefits in terms of reduced mortality, the ministry said.

“It (remdesivir) has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury. Similarly, for tocilizumab studies have not shown any benefits in mortality reduction,” the statement said.

“However, if used for patients with severe conditions, proper informed consent is required. Rampant use is to be discouraged since the effect of the drug is directed at the ‘cytokine storm’,” it said. A cytokine storm is a severe immune reaction.

The ministry said all ‘investigational therapies’ are required to be carried out only in proper health care facilities where close monitoring of patients is possible so that potential complications can be managed.

The ICMR strongly recommended that the focus of clinical management should continue to remain on oxygen therapy, steroids which are widely available and inexpensive, appropriate and timely administration of anti-coagulants and high quality supportive care, including mental health counselling for patients and families, management of pre-existing illness and palliation of symptoms, the ministry said.

It said the pursuit of an effective treatment for COVID-19 has resulted in repurposing of several drugs which are not part of the main Clinical Management Protocol but have been indicated as “investigational therapies.”

“These drugs have still not been approved by the Drugs Controller General of India (DCGI) and are only permitted for restricted Emergency Use for COVID-19,” it stated.

These can be used in specific sub-groups of patients on the basis of informed and shared decision making with the patient before prescribing these drugs, the statement said.

“The States as well as the Medical College hospitals designated as Centres of Excellence were reminded by ICMR and AIIMS that their indiscriminate use or use in conditions for which they are not desirable, may cause more harm than good,” it further said.

Based on severity of symptoms, COVID-19 can be categorised into three groups “mild, moderate and severe.”

During the video conference with states, ICMR and AIIMS emphasised that in the absence of a cure, the standard of care treatment for mild, moderate and severe cases as described in the Clinical Management Protocol of the health ministry would be most effective.Â

For moderate and severe cases, adequate oxygen support, appropriate and timely administration of anti-coagulants and widely available and inexpensive corticosteroids, in accordance with the protocol, can be considered to be the mainstay of COVID-19 therapy, the ministry stated.

For mild cases, which are nearly 80 per cent of the total cases, Hydroxychloroquine (HCQ) has been recommended. The standard of care treatment strategies have shown to yield positive results, it added.

Anti-viral Remdesivir will be given directly to hospitals, says Tamil Nadu govt

Anti-viral drug Remdesivir would be made available directly to private hospitals to avoid overcrowding in places designated for its prescription based sale by state authorities to the kin of COVID-19 patients, the Tamil Nadu government said here on Sunday.

Effective May 18, a facility would be made available to private hospitals to register their drug requirement in a portal and only their representatives should collect the medicine from sale depots.

While information on the portal would soon be released, the hospitals must furnish information related to intended recipients, the oxygen dependent patients, the government said in an official release.

The state-run Tamil Nadu Medical Services Corporation provided the drug to government hospitals.

For patients in private facilities, it was being made available to the families of COVID-19 patients through government sale centres in Chennai, Coimbatore, Salem, Tiruchirappalli, Madurai and Tirunelveli.

The government said authorities would monitor if Remdesivir was used by private hospitals only for eligible patients and whether it was sold to patients at the same price at which it was bought from its centres.

Legal action would be taken against those who violate norms and if patients were recommended Remdesivir without any necessity, the government said.

Following a meet chaired by Chief Minister M K Stalin to review the current practice of providing the drug to people through direct sale, the government said only in Tamil Nadu Remdesivir was being sold directly to the families of people infected by the virus.

Overcrowding in places where Remdesivir is being sold made following physical distancing impossible and also led to the possibility of virus spread and hence this has to be avoided, the government said.

There were also complaints alleging that some who got the drug from centres sold it in the black market and experts opined that Remdesivir had a limited efficacy only for patients on oxygen support.

Considering such factors, and to see that people do not face hassles, the Chief Minister advised top officials to change the current practice and provide it only to hospitals.

Relatives of patients should not be tasked to buy the medicine directly, he told the officials.

Medical and Family Welfare Minister Ma Subramaniam and top officials including Health Secretary J Radhakrishnan took part in the meet held at the Secretariat.

On Saturday, public health expert Prabhdeep Kaur tweeted (on overcrowding to get the drug), “This is perfect setting for #Covid19 cluster. Will make lockdown ineffective. Remdesivir is not a life saving drug. Yet, if Govt wants to help patients in private hospitals – it should be given directly to the hospitals @CMOTamilnadu @Subramanian_ma.

In Video: To avoid overcrowding, Remdesivir will be given directly to hospitals: Tamil Nadu Govt

CIDCO to build 2,000-bed Covid care centre in Mumbai’s Kanjurmarg suburb

Maharashtra government’s city planning body, the City and Industrial Development Corporation (Cidco), is working on building a 2,000-bed Covid-19 treatment jumbo centre in Mumbai’s central suburb of Kanjurmarg.

The proposed centre will be set up at the old Crompton Greaves factory land and will have 1,400 oxygenated, 200 ICU and 400 non-oxygenated beds for Covid-19 patients.

Cidco, which is usually mandated for assignments outside Mumbai, particularly Navi Mumbai, has been entrusted with the job to fast-track the construction of this jumbo Covid care centre in Mumbai.

Apart from this, Cidco is also building an 800-bed Covid centre at the Cotton Corporation of India Ltd’s warehouse in Navi Mumbai’s Kalamboli area with 690 oxygenated and 110 ICU beds.

“We are doing our best to assist the state administration in the fight against the pandemic and will continue the same in future,” said Sanjay Mukherjee, VC & MD at Cidco. “Both these dedicated Covid health centres once constructed, will be handed over to respective municipal corporations for future operations.”

So far, all the Covid treatment centres in Mumbai have been constructed by Municipal Corporation of Greater Mumbai (MCGM) and Mumbai Metropolitan Region Development Authority (MMRDA).

While Mumbai has recorded a steady decline in the number of Covid positive cases over the last three weeks, the government is working on new facilities to ensure no shortage in case of any new spike.

On Sunday, Mumbai reported 2,403 Covid positive cases with a doubling rate of 153 days as against 9,327 cases a month ago on April 10 with a doubling rate of 34 days.

Currently, Mumbai has jumbo Covid care centres in locations across the city including Worli, Bandra-Kurla Complex (BKC), Goregaon and Mulund. The new centre is part of additional three new large facilities that will be built in the next few weeks. Cidco has already floated the tenders for the proposed centre in Kanjurmarg.

The hospitals will be developed in accordance with administrative and financial procedures under emergency procurement mentioned in the state government’s December 2016 resolution and procurement of goods manual of the government of India for handling procurement in emergencies and disaster management.

The concerned municipal corporations will be responsible for infrastructural facilities along with power and water supply, appointment of doctors as well as other medical professionals, obtaining the required certificates, general security and provisions for fire safety, beds, supply of medicines and other equipment, etc.

Novartis signs $50 million deal for Mesoblast cell therapy for COVID and beyond

ZURICH:

Novartis

aims to boost its respiratory treatment portfolio with a $50 million deal for an off-the-shelf cell therapy from Mesoblast that it hopes to deploy for COVID-19 patients as well as others suffering from respiratory distress.

The Swiss drugmaker’s deal with Australia-based Mesoblast secures rights to develop, commercialize and manufacture Remestemcel-L for treating acute respiratory distress syndrome (ARDS), including that associated with COVID-19, for which the therapy is currently in late-stage trials.

While the therapy has shown promise in COVID-19 patients — — in a compassionate use programme in March in 12 patients, Remestemcel-L was associated with an 83% survival rate — Novartis wants the medicine for beyond the pandemic, too, to help patients who in normal times also land in the hospital with ARDS and often die.

“It has the potential to be the first treatment for the most critically ill ARDS patients, and it provides us with an opportunity to apply years of specialized experience directly to the work of saving lives,” Novartis’s chief drug developer, John Tsai, said on Friday.

Unlike Kymriah, Novartis’s cancer cell therapy, Remestemcel-L does not have to be tailored for each patient. Once the deal is closed, Novartis said it is planning to help Mesoblast work on quality attributes of the therapy so it meets U.S. Food and Drug Administration requirements necessary for late-stage trial beyond COVID-19.