×

UPSC Courses

DNA banner

DAILY NEWS ANALYSIS

GS-III :
  • 12 May, 2020

  • 10 Min Read

ICMR's clearance on using convalescent plasma therapy

ICMR's clearance on using convalescent plasma therapy

Context

The U.S. FDA and India’s ICMR have approved the use of plasma from recovered COVID-19 patients only for trial purposes.

With the ethics committee approval in hand on May 8, the ICMR cleared the last hurdle to conduct a multicentric phase-2 trial using convalescent plasma on COVID-19 patients with moderate illness.

Phase 2 trial- to check the efficacy of Plasma therapy

  • Its three feasibility studies in about 20 severely ill patients found the therapy to be safe and able to resolve illness or improve the clinical symptoms.
  • Since safety of convalescent plasma from people who have recovered from COVID-19 illness is not a huge concern, the first stage of the human clinical trial has been skipped; the ICMR will instead study plasma safety and efficacy in a phase-2 trial with 452 patients.
  • The patients with moderate COVID-19 illness will be randomly assigned to receive either convalescent plasma (226 participants) or only standard of care (control group).
  • The primary outcomes of the trial in 21 hospitals that will be studied include prevention of illness from progressing to a severe form, and avoidance of deaths from all causes at 28 days after plasma infusion.
  • And key secondary outcomes will include resolution of symptoms, reduction in hospital stay and respiratory support.
  • Plasma will be collected from donors 28 days after they make a complete recovery from illness or are symptom-free and have more than the required level of antibodies against the novel coronavirus.
  • Molecular and also other routine tests will be done before plasma use.

Convalescent plasma therapy

Convalescent plasma therapy, about a century old, has shown some benefit in treating measles, chickenpox and rabies.

Small studies have shown faster clearance of virus in the case of MERS and SARS if given early in the course of the disease .

Issues in Convalescent plasma therapy

  • No randomised controlled studies have been carried out.
  • No benefit was seen in 2015 on some Ebola patients treated with convalescent plasma in Guinea.
  • Only three small studies involving 21 COVID-19 patients have been carried out but not in trials where the participants were randomised with a control arm.
  • Till date, there is a dearth of randomised controlled trials that clearly demonstrate the efficacy of convalescent plasma therapy for any infectious disease, including COVID-19.

Way Ahead

Even in the absence of any effective treatment or a vaccine, the pandemic provides an opportunity to ascertain the clinical benefits of plasma therapy through randomised controlled trials.

The ICMR’s insistence on an evidence-based approach to plasma therapy is in contrast to the cavalier manner in which it approved the anti-malarial hydroxychloroquine, as a prophylaxis(treatment given or action taken to prevent disease) for coronavirus without carrying out any trial and relying on evidence that was slim and intended only for treatment, and also when the risks were unknown.

If the trial outcomes are overwhelmingly positive, the agency would be ethically obliged to recommend plasma therapy as a standard of care for COVID-19 patients.

Source: TH


Pradhan Mantri Suryodaya Yojana

Recently, Prime Minister announced Pradhan Mantri Suryodaya Yojana under which 1 crore households will get rooftop solar power systems. India’s Status of Current Solar Capacity India currently stands at 4th place globally in solar power capacity. As per Ministry of New an

Foreign Contribution Regulation Act (FCRA)- NGO 

The Foreign Contribution Regulation Act, 2010 (FCRA) registration of two prominent non-governmental organisations (NGOs) — Centre for Policy Research (CPR) and World Vision India (WVI) have been cancelled this month. What is FCRA? Key provisions of FCRA, 2010 Key aspects Description

Voice clone-AI

Voice clone fraud has been on the rise in India. AI voice cloning – It is the process of creating a synthetic replica of a person’s voice through machine learning and speech synthesis technology.It is called as voice deepfakesor audio deepfakes. Objective – To achieve a high level of na

Science communication- how to promote

Steps taken by India to promote Science Communication Publications and Information Directorate (PID) - An organisation under Council of Science and Industrial Research (CSIR) established in 1951 for publishing and disseminating scientific information in India. National science magazines- The PI

Universal Basic Income (UBI)- Analysis

Universal Basic Income (UBI) can strengthen welfare architecture and unlock the nation’s latent demographic potential. UBI - It is an income support mechanism typically intended to reach all or a very large portion of the population regardless of their earnings or employment status. Objective- To provide enough to co

Toppers

Search By Date

Newsletter Subscription
SMS Alerts

Important Links

UPSC GS Mains Crash Course - RAW Prelims Answer Key 2024