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CSIR INSTITUTE TO CONDUCT CLINICAL TRIALS UMIFENOVIR

CSIR Institute to conduct clinical trials of Umifenovir

Context:

The Central Drug Research Institute (CDRI), Lucknow has received permission for carrying out Phase III trials for the use of Umifenovir against Covid-19. These trials will be randomized, double-blind, placebo-controlled that will test the efficacy, safety, and tolerability of the drug.

  • The CSIR is evaluating Mycobacterium W (Mw) for faster recovery of hospitalized Covid-19 infected patients.
  • The clinical trial of the Favipiravir drug has also been allowed by the Drug Controller General of India (DCGI).

Randomized, Double-blind, Placebo-controlled Trials:

  • Randomized trials mean that subjects are randomly assigned to placebo and intervention groups.
    • Placebo is anything that looks like a real treatment but it is actually not. for example sugar pills and saline injections.
  • Double-blind means that neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. This ensures that the result of trials is not affected by the biases of researchers and patients.
  • Placebo-controlled trials refer to a control group receiving a placebo. This sets it apart from studies that simply give participants treatment and record the results.
    • Here, a control group is given a placebo while another group is given the drug (or other treatment) being studied. That way, researchers can compare the drug's effectiveness against the placebo's effectiveness.

Working of Umifenovir:

  • Umifenovir inhibits membrane fusion of the influenza virus. Umifenovir prevents contact between the virus and target host cells.
  • The fusion between the viral envelope and the cell membrane of the target cell is inhibited. This prevents viral entry to the target cell and therefore protects it from infection.
  • The drug is manufactured by Pharmstandard

Advantages: 

  • Improve Immune System: It acts by preventing entry of the virus into human cells and also by priming the immune system.
  • Indigenously Developed: All the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against Covid-19.
  • Safe: Umifenovir has already been used for the treatment of influenza in China and Russia and therefore is safe. It recently came into prominence due to its potential use for Covid-19 patients. The clinical trial is to evaluate its efficacy in Indian patients.
  • Prophylactic Use: It has the potential for prophylactic use. A prophylactic is a medication or a treatment designed and used to prevent a disease from occurring.

Source: The Hindu