ICMR has revised the protocol for clinical management of COVID-19. It has allowed the use of remdesivir, tocilizumab and convalescent plasma therapy (CPT) on certain groups of patients.
The document says, “Remdesivir (under Emergency Use Authorization) may be considered in patients with moderate disease (those on oxygen)… Tocilizumab (Off Label) may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite the use of steroids. Long term safety data in COVID-19 remains largely unknown… Convalescent plasma (Off Label) may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite the use of steroids.”
Though the revised protocols allow hydroxychloroquine to be prescribed to patients in the early course of the disease, it has also advised against the use of the anti-malarial drug in patients with the severe disease since the evidence for its use “remains limited”. The ICMR document also states that its use should be only after “shared decision making with the patients” and recommends an ECG before the drug is prescribed to patients.
The permission to use azithromycin in combination with hydroxychloroquine (HCQ) to treat patients with severe coronavirus infections has been rolled back.
Commenting on the new protocols, Harish Jain, Secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association told Usha Sharma from Express Pharma, “Any pandemic outbreak is a challenge for the healthcare system and authorities and COVID-19 is no exception. As the understanding of the pandemic gains momentum and infrastructure for new therapy gears up, it calls for dynamic changes in Clinical Management Protocol. The announcement by the ICMR on 13th June is a step in the right direction. This step is taken after analysing the available knowledge and therapies related to COVID-19 treatment. The protocol will guide medical fraternity to treat their patients as well as pharma companies to gear up production of recommended drugs.