Indian health authorities have decided to review the protocol followed at present for the treatment of Covid-19 after interim results from a large World Health Organization trial found four of the commonly used drugs provide little or no benefit in reducing fatalities in hospitalised patients.
Among these are antiviral drug remdesivir, malaria 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 in the Union ministry of health and family welfare said that the protocol will be reviewed in the next joint task force meeting headed by Dr VK Paul, member (health), Niti Aayog, and director general, Indian Council of Medical Research (ICMR), Dr Balram Bhargava.
“Yes, we will be revisiting the clinical management protocol in the light of new evidence before us,” Dr Bhargava told HT.
While HCQ has been approved for off-label use in moderately ill Covid-19 patients by the drugs controller general of India, remdesivir has been approved under the emergency use authorisation.
Known as the WHO’s Solidarity Trial, the study that now casts doubt on the effectiveness of these drugs covered 405 hospitals in 30 countries.
The data was randomised and came from 11,266 adults being treated for Covid-19. Of them, 2,750 were allocated remdesivir, 954 HCQ, 1,411 lopinavir, 651 interferon plus lopinavir, 1,412 only interferon, and 4,088 were on no study drug.
India was also a part of the trials and tested these four drugs. According to ICMR, which coordinated the trials in the country, there were 26 actively randomising sites with 937 participants as of October 15, 2020.
“…The interim results show that no study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics) or initiation of ventilation in hospitalized Covid-19 patients,” said ICMR in a statement.
Experts say some crucial questions have been answered in this trial. “The objective of this trial was to see whether these drugs work or not. We have found the answer that these do not work, and it was crucial to get this answer. Then there are certain soft end points like if there are any particular subsets that benefit more; like Americans are saying that it cut shorts the recovery time etc., which we will get to know as the trial is ongoing,” said study co-author Dr K Srinath Reddy, founder, Public Health Foundation of India.
Dr Reddy is also a member of several central committees on Covid-19, including ICMR task force.
“For drugs such as interferon the trial has shown that it is almost on the verge of doing harm to hospitalized patients, so there is no point in continuing with this arm. We could now try other available drugs that may also be cheaper,” he added.
After the trial results were out, WHO hinted that it would make changes to its trial arm – the groups that get different treatment.
“Newer antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies are now being considered for evaluation,” said the WHO statement.
For now, the UN body has discontinued the interferon arm based on the evidence found against it but plans to continue the remdesivir arm in order to increase the precision of the findings.
Critical care specialists, however, these drugs are secondary, there are other measures that make a huge impact in saving lives of hospitalized Covid-19 patients.
“My experience has been that four things work in saving a serious patient: oxygen therapy, steroids, heparin (blood thinner), and the state of care that includes infrastructure in the ICU, training of staff etc. Jury is still out on how beneficial are the rest of the things, including investigational therapies,” said Dr Anjan Trikha, professor, department of anaesthesia, critical care and pain medicine, All India Institute of Medical Sciences (AIIMS), Delhi.