| New Delhi |
Updated: June 13, 2020 4:56:33 pm
India has revised the protocol for clinical management of COVID-19 to include use of remdesivir and off-label use of tocilizumab and convalescent plasma therapy on very specific groups of patients. The list of symptoms has also been revised to include loss of smell and taste.
While remdesivir a drug originally developed for Ebola is being repurposed for COVID-19, tocilizumab is used in autoimmune disorders. Convalescent plasma therapy (CPT) involves transfusion of the blood plasma of a recovered patient into another patient. It has been used for many other diseases but its efficacy for COVID-19 is still under investigation. Meanwhile, Hydroxychloroquine will continue to be in use but the antibiotic azithromycin is no longer a part of the treatment protocol.
Apex health bodies across the world, including the Centers for Disease Control and Prevention, have in the last couple of months included loss of smell among the list of COVID symptoms. Loss of smell and taste have been added as symptoms in addition to fever, cough, fatigue, shortness of breath, body ache, sore throat and diarrhoea.
The revised clinical management protocol released by the Ministry of Health on Saturday said: “As per data from Integrated Health Information Platform (IHIP)/ Integrated Disease Surveillance Programme (IDSP) portal case investigation forms for COVID 19 (n=15,366), the details on the signs and symptoms reported are (as on 11.06.2020), fever (27%), cough (21%), sore throat (10%), breathlessness (8%), Weakness (7%), running nose (3%) and others 24%.”
The protocol lays down the need for treating mild, moderate and severe cases differently, reiterates that RT-PCR is the only acceptable diagnostic test and emphasises the importance of oxygen therapy. The median incubation period, it lays down is 5.1 days (range 2–14 days). “The precise interval during which an individual with COVID-19 is infectious is uncertain. As per the current evidence, the period of infectivity starts two days prior to onset of symptoms and lasts up to eight days. The extent and role played by pre-clinical/ asymptomatic infections in transmission still remain under investigation,” says the protocol document which will now be the bible for doctors across the country treating COVID patients.
Under the section on investigational therapies, appear remdesivir, tocilizumab and CPT, it 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 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 use of steroids. For each of the three certain conditions and contraindications have been laid down.”
For example, remdesivir is not to be used in severe renal impairment or administered to kids below 12 years or pregnant or lactating mothers. Tocilizumab should be used only after existing infections have been checked for and tuberculosis has been ruled out.
On Hydroxychloroquine, which has been the subject of much scientific flip flop for the past few weeks, the document says: “This drug has demonstrated in vitro activity against SARS-CoV2 and was shown to be clinically beneficial in several small single center studies though with significant limitations. Nonetheless, several large observational studies with severe methodologic limitations have shown no effect on mortality or other clinically meaningful outcomes. As such, the evidence base behind its use remains limited as with other drugs and should only be used after shared decision making with the patients while awaiting the results of ongoing studies. As is the case with other antivirals, this drug should be used as early in the disease course as possible to achieve any meaningful effects and should be avoided in patients with severe disease. An ECG should ideally be done before prescribing the drug to measure QTc interval”.
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