Indian health authorities have decided to revise the protocol currently being followed for the treatment of Covid-19 after interim results of a large World Health Organization trial found that four of the drugs used common provide little or no benefit in reducing deaths in hospitalized patients.
These include the antiviral drug remdesivir, the antimalarial drug hydroxychloroquine (HCQ), an anti-HIV combination of lopinavir and ritonavir, and the immunomodulator interferon. The first two are prescribed for moderately ill Covid-19 patients.
A senior official from the Union Ministry of Health and Family Welfare said the protocol will be reviewed at the next joint working group meeting headed by Dr. VK Paul, member (health), Niti Aayog, and director general of the Indian Council. of Medical Research (ICMR), Dr. Balram Bhargava.
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“Yes, we will review the clinical management protocol in light of the new evidence before us,” Dr. Bhargava told HT.
Although HCQ has been approved for off-label use in moderately ill Covid-19 patients by India’s general drug controller, remdesivir has been approved under emergency use authorization.
Known as the WHO Solidarity Trial, the study that now casts doubt on the effectiveness of these drugs covered 405 hospitals in 30 countries.
The data was randomized and came from 11,266 adults who were being treated for Covid-19. Of these, 2,750 were assigned remdesivir, 954 HCQ, 1,411 lopinavir, 651 interferon plus lopinavir, 1,412 interferon only, and 4,088 received no study drug.
India was also part of the trials and tested these four drugs. According to ICMR, which coordinated the trials in the country, there were 26 active randomization sites with 937 participants as of October 15, 2020.
“… Interim results show that no study drug definitively reduced mortality (in non-ventilated patients or any other subset of input characteristics) or initiation of ventilation in hospitalized patients with Covid-19,” ICMR said in a statement.
Experts say that this trial answered some crucial questions. “The goal of this trial was to see if these drugs work or not. We have found the answer that these don’t work, and it was crucial to get this answer. Then there are certain soft end points as if there were some particular subset that would benefit the most; as the Americans are saying it shortened the recovery time etc which we will learn about as the trial is ongoing, ”said study co-author Dr K Srinath Reddy, founder of the Public Health Foundation of India .
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Dr. Reddy is also a member of several core committees on Covid-19, including the ICMR working group.
“For drugs like interferon, the trial has shown that it is almost on the verge of harming hospitalized patients, so there is no point in continuing with this arm. Now we could try other available drugs that may also be cheaper, “he added.
After the trial results were published, the WHO hinted that it would make changes to its trial arm – the groups receiving a different treatment.
“New antiviral drugs, immunomodulators, and anti-SARS COV-2 monoclonal antibodies are now being considered for evaluation,” the WHO statement said.
For now, the UN body has discontinued the interferon arm based on the evidence found against it, but plans to continue with the remdesivir arm to increase the precision of the findings.
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Critical care specialists, however, these drugs are secondary, there are other measures that have a great impact on saving lives of hospitalized patients with Covid-19.
“My experience has been that four things work to save a seriously ill patient: oxygen therapy, steroids, heparin (anticoagulant) and the state of care that includes the infrastructure in the ICU, the training of personnel, etc. The jury is still out on the benefits of everything else, including investigational therapies, ”said Dr. Anjan Trikha, professor in the department of anesthesia, intensive care and pain medicine at the Indian Institute of Medical Sciences ( AIIMS), Delhi.
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