In what could leave a huge gap in COVID-19 investigational therapies, the Indian Council of Medical Research (ICMR) and the national task force is considering to delete convalescent plasma therapy from its national COVID-19 treatment protocol guidelines. The decision, if taken, will be based on clinical trials conducted by ICMR that showed plasma therapy did not reduce COVID-19 mortality or disease progression.
Convalescent plasma therapy at present is listed as "off-label" use and as an investigational therapy in national guidelines.
In a press briefing, Director General of ICMR Dr Balram Bhargava said, "We have done a large clinical trial on plasma, it will be published in the British Journal. Discussing within the task force on may be deleting plasma therapy from our national covid19 treatment guidelines."
ICMR's PLACID (Plasma Convalescent India) trial, the first and largest randomised control trial in the world, released a pre-print of results in early September. The trial with 464 hospitalised patients with moderate COVID-19 symptoms across 39 hospitals showed plasma therapy had no benefit in reducing mortality in moderate to severe cases of COVID-19.
Plasma therapy did not arrest progression of COVID-19 from moderate to severe. However, some patients saw symptoms reduced and improved oxygenation saturation and faster viral clearance in patients who received plasma therapy.
The move holds significance, particularly after WHO trials -- in which India was a participant -- showed that another potential treatment Remdesivir, was not effective in reducing mortality or hospital stay. ICMR is also "debating and discussing the use of Remdesivir and will take the results of these trials into consideration".
In June, the Health Ministry had recommended off-label use of plasma therapy for only those COVID-19 patients who showed no improvement despite receiving standard treatment.
While the Centre had held that plasma therapy is experimental, and "illegal" unless it is administered in a facility that was part of the ICMR study, the therapy has seen a widespread acceptance.
Delhi and Maharashtra -- two states that saw large numbers of COVID-19 cases -- have taken to plasma therapy in a big way. Both states have been conducting multiple trials, setting up plasma banks and promoting donation of plasma from recovered patients.
However, doctors are divided on the therapy. Some medical professionals have questioned the need for a costly plasma therapy, which is proven to not benefit patients. Moreover, reports suggest that family members of COVID-19 positive patients have been running from pillar to post to arrange for plasma from recovered patients.
Nonetheless, some have pointed out that the Delhi government's phase 1 trials on plasma showed results similar to ICMR’s trials, where therapy reduced oxygen requirement in patients and the duration where they remained breathless was reduced.
After complaints of rampant usage, mostly in mid-tier towns, the central health ministry had in August directed private hospitals to not use experimental therapies such as convalescent plasma or Remdesivir routinely for treating COVID-19 patients.
ICMR is now working on developing horse sera containing antibodies against the Sars-Cov2 virus as a potential treatment for COVID-19. It is partnering with Hyderabad based Biological E and has completed animal trials with horse sera, human trials are under approval stage.