Convalescent plasma does not lessen risk of death in moderate Covid patients: ICMR

Mangalore Today News Network

New Delhi, Sep 09, 2020: A new study backed by the Indian Council of Medical Research (ICMR) indicates that convalescent plasma (CP) therapy may not lessen the risk of death in moderate and severe Covid-19 patients.

 

The study titled ‘Convalescent plasma in the management of moderate COVID-19 in India: An open-label parallel-arm phase II multicentre randomized controlled trial (PLACID Trial)’ said administering plasma therapy did not reduce the risk of mortality in moderate to severe coronavirus cases.

It went on to suggest that plasma therapy was not capable of stopping the progression of infection.

The results were published in preprint server MedRxiv on September 8, 2020.

The PLACID trial results indicate that there was no difference in 28-day mortality or progression to severe disease among moderately ill Covid-19 patients treated with CP along with BSC compared to BSC alone.

Additionally, there were no differences in outcomes between study participants receiving CP with detectable (neutralising antibodies) NAb titres compared to BSC alone; or between those receiving CP with NAb titres more than or equal to 1:80 and those receiving BSC alone.

Simply put, the trial compared results in patients who were given only the best standard of care (BSC) with those administered CP along with BSC. BSCs are generally accepted treatment protocol, used widely by clinicians.

In case of Covid-19, BSCs in India include antivirals like Hydroxychloroquine, Remdesivir, Lopinavir/Ritonavir, Oseltamivir, Tocilizumab and more. The list also includes Antibiotics, Steroids and Supportive management (oxygen, masks, ventilation etc).

A total of 1,210 patients admitted across 39 trial sites were screened between April 22 to July 14 2020.

The study said 464 patients were randomized into intervention or CP + BSC arm (n=235) and control or BSC arm (n=229).

The outcome at 28 days was not available for 2 patients (one each in intervention and control arm) as they were “lost to follow-up” after discharge from hospital; 9 patients (5 in intervention and 4 in control arm) withdrew consent after randomization.

Most of the donors were male (94.3%), with mean age of 34.3 (9.3) years. The median disease duration was 6 (3,11) days and most of the donors (94.2%) had mild disease. Plasma was donated after a median (IQR) of 41 (31,51) days from COVID-19 diagnosis by RT-PCR.

Participants who received CP complained of minor adverse events of pain in local infusion site, chills, nausea, bradycardia and dizziness. Fever and tachycardia were reported in three patients. Dyspnoea and intravenous catheter blockage were noted in two participants each. Mortality was assessed as possibly related to CP transfusion in 3 patients (1.3%).

"Our results mirror the experience of the ConCOVID trial, where 79% of the participants had detectable antibodies at baseline,” said the study.

"On the other hand, the NAb titres in CP in our study was similar to the results by Long et al, who found 13-40% patients turned seronegative in the early convalescent phase. In a 175-patient series, Wu et al documented that 30% of patients generated very low levels of NAb with titres correlating to increasing age and disease severity. We found participants had higher antibody positivity and median NAb titres than CP donors,” the study further said.

The difference in age and severity of illness, with donors being younger and having milder disease, could have driven this difference.

While all Covid-19 survivors were encouraged to donate plasma, an overwhelming majority of the donors were only mildly sick and young survivors. Recovered patients who had moderate or severe disease were generally reluctant to return to hospitals for plasma donation.

This has major implications for obvious operational reasons as CP therapy for Covid-19 gets scaled up as a component of the virus management strategy not only in India but also globally.

There was no difference in NAb titres in the two arms despite CP transfusion. This suggests that there may not be any benefit of treating moderate to sick elderly people with CP collected from young people who have recovered from mild Covid-19 infection.

In India, convalescent plasma has been approved by the DGGI on an off-label basis (without trials) — an emergency measure.

Various governments have encouraged it just like the private sector. The study is important as it is indicates that plasma therapy may not be a lifesaver in all Covid-19 patients.

US President Donald Trump spoke about use of plasma therapy for Covid-19 patients, not before Delhi Chief Minister Arvind Kejriwal who said “US follows what Delhi does” in a tweet.

Delhi already has a plasma bank with 3 dedicated facilities that have been opened to all patients. States like Maharashtra also started a plasma bank following Delhi’s footsteps.

Scientists and experts have continued to call plasma therapy as an experimental treatment for coronavirus in the absence of a vaccine, but it is not an effective cure for the deadly virus.


courtesy:IndiaToday