Amended Protocol Ver. 1.4 Developed By Icmr For Covid 19 Patients Treatment Through The Convalescent Plasma

The novel coronavirus that started in Wuhan, China in December 2019, had quickly been declared as a pandemic by the World Health Organization. It is caused by severe acute respiratory syndrome coronavirus 2 and has resulted in millions of cases and deaths all over the world. rnSome of the clinical manifestations of Covid 19 include fever, fatigue, and cough, shortness of breath along with some of the less common symptoms like headache, diarrhoea and nausea. Along with several irregularities of parameters in the body, hypoxia-induced thrombosis enhances blood viscosity as well as hypoxia-induced transcription factor-dependent signaling pathway. Covid-19 also attacks the beta chain of hemoglobin for iron dissociation to make porphyrin. This decreases the lungs ability to exchange oxygen and carbon dioxide that results in ground-glass opacities. Till now there are no certain treatment methods for Covid-19 and several trials are being made all over the world to study the efficiency of several treatment strategies. Most recently, convalescent plasma from recovered patients has been approved for treating severe infection of Covid-19 infection. Infusion of this plasma has shown improvement in the clinical status of many patients. In India, DCGI has allowed ICMR along with other research institutes to carry out clinical trials for using Convalescent Plasma for treatment of Covid-19 infection. DCGI has forwarded a protocol for conducting a phase II, open-label and random control trials for studying the safety as well as the efficiency of convalescent plasma treatments. As per the protocol, the blood that consists of plasma collected from the SARS-CoV-2 infected patients is collected and the plasma is separated. Then it is administered to other infected persons and is investigated as one of the treatment methods. rnThe convalescent plasma therapy possesses the potential for treating the Covid-19 viral infection causing devastation across the world. It has already been used previously to treat diverse infectious diseases in the past. Especially in times of pandemic or instant outbreak. Since it is an already tested treatment solution in many diseases. It’s relevance was inevitable in the treatment of the Covid-19 virus. The treatment has been found to be relatively safe in initial testing with minor side effects. The known general risks of plasma transfusion therapy are allergic reactions, transfusion-associated circulatory overload (TACO), and transfusion-associated acute lung injury (TRALI). Overall, it is the most suitable and widely used treatment for Covid-19 at the moment. However, researchers are also working on the development of other suitable drugs that’ll also fall under the purview of medical device regulation in India when they reach the markets.