The emergency use approval authorisation by US Food and Drug Administration (US FDA) to use plasma as a potential therapy for Covid in US is expected to provide impetus to its used as yet ‘promising’ treatment option in India, even as doctors say clear scientific evidence is needed.
The US President announced US FDA approval on August 23, though the agency put it on hold over doubts on it’ efficiency. Doctors claim that the therapy of using recovered Covid-19 patients plasma to treat infected people will get even more widespread in India, given the endorsement from US. This would be similar to the sharp surge in demand witnessed for anti-malarial drug hydroxychloroquine as a potential covid 19 treatment, after President Trump’s repeated backing and later failed in global trials.
US FDA previously issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile (SNS)to be distributed and used for hospitalized Covid-19 patients. In fact, these two drugs have been used for decades for the therapy and control of malaria and autoimmune diseases.
Preliminary studies have suggested HUQ may have utility in fighting covid-19. Distinct possible effects may be selected to its function in the treatment of covid-19 patients : A. anti-virus, B. anti-inflammation and C. anti-thronebotic. As until now there have been no data indicating HCQ has any immunity boosting effect, here we will mainly discuss the anti-virus and anti-inflammation effects. Both CQ and HCQ have been shown to possess anti-viral activity against various viruses such as human immunodeficiency virus (HIV), hepatitis A virus, hepatitis C virus, influenza A and B viruses, influenza A HSNI virus and others. Recent studies reported that CQ and HCQ could also inhibit SARS-CoV-2 in vitro, suggesting that they are potentially applicable to Covid-19 patients. However, there is to date no convincing report of the in viro anti-viral effects of HCQ/CQ. Several randomized controlled trials brought comforting news that CQ and HCQ showed potential effects in reducing respiratory symptoms and pulmonary inflammation as evaluated by computed tomography (CT) of covid 19 patients. It led to panic buying as people attempted to acquire this purpoted ” life saving drug”. Even some physicians stocked up CQ and HCQ for personal use in US and some European countries.
One person in US died and another become seriously ill after using verterinary formulation of CQ tablets intended for use in fish tanks in an effort to present Covid-19. Shortly after permitting the use of CQ and HCQ for treating covid-19, the US FDA issued precautions on using those drugs. Hence, we believe that serious discussions of the potential mechanisms are urgently needed to guide the potential clinical application, evaluation of efficacy and prevention of adverse effects of these drugs.
Plasma therapy has become the most common and simple treatment used niw-a-days in Covid-19 treatment. The US FDA announced that convalescent plasma may be effective in treating covid-19 and potential benefits of the product outweigh the risks based on scientific evidence available.
In India, multi-centre clinical trials to study whether plasma therapy is a useful covid-19 treatment are underway by the Indian Council of Medical Research. Further, States like Maharashtra are running the world’s largest plasma therapy trials, Project Platina, in 18 medical colleges, but response from donars reportedly has been lackluster. Covid therapy is highly individualised. The use of plasma therapy can be life-saving in certain cases and is being used in compassionate grounds. It is a promising treatment option if used earlier in the cycle of the disease. It has been used as therapy for over 100 years, but for COVID-19, we need to document this in a research programme. We also need better methodology for its use while screening donors so as to know the adequate level of neutralizing antibody, ortiters”, told Dr.Shashanka Josh.
Significantly, World Health Organisation on Monday remaind cautious about endorsing the use of plasma to treat infected people. “The results are not conclusive”, its chief scientist Soumya Swaminathan said’ adding ” We recommend that convalescent plasma is still and experimental therapy, and should be continued to be evaluated in well-designed randomised clinical trials.”
The US FDA decision was based on an observational study that gave “some positive signals that convalescent plasma can be helpful in treating COVID-19” and might reduce the mortality if administered early after diagnosis. This article is posted on preprint service and is yet to find its way into a medical journal. However, the claims made by the US FDA commissioner have considerably done more harm to the science and raised unrealistic hopes among the public.
In India, plasma is being promoted asking people to donate plasma to save lives, and shaming COVID-19 survivors who chose not to donate. We seem to have accepted plasma therapy widely without any good quality evidence supporting its use. This is likely to give even more widespread with the endorsement from the US, said Dr.Lancelot Pinto consultant respirologist at Mumbai-based PD Hinduja Hospital.
Plasma reduces death rates if there are enough neutralizing antibodies in the donor plasma. As of now, our labs are not accurately measuring the titres of antibodies in donor plasma – thus it is a wild guess if plasma administered to the COVID patient would indeed benefit the patients”, Kalantri added.
US FDA’s statement implies a 35% absolute improvement in outcomes, when the reality is a 32% improvement and that two comparing early late plasma, Dr.Pramesh said, adding, the danger of such a public statement is that ongoing randomised trials of convalescent plasma will struggle to recruit patient. However, the US FDA still recommend that randomised trials of plasma continue.