The health ministry has provided protocol on use of Remdesivir, Convalescent plasma, Toclizumab, and Hydroxychloroquine.
The Ministry of Health and Family Welfare released the Clinical Management Protocol for COVID-19 on June 13. The document provides guidelines on identifying and categorising patients and treatment protocols.
The health ministry has provided protocol on use of Remdesivir, Convalescent plasma, Toclizumab and Hydroxychloroquine.
Before there is a caveat.
"At present, use of these therapies is based on a limited available evidence. As the situation evolves, and when more data become available, the evidence will be accordingly incorporated, and recommendation upgraded. Further, use of these drugs is subjected to limited availability in the country as of now," the ministry advisory said.
Remdesivir is approved by Indian regulator under Emergency Use Authorization. The protocol says the Gilead's antiviral drug may be considered in patients with moderate disease or those on oxygen.
The protocol advises giving the drug against people with liver disease, kidney failure, pregnant or lactating women, and children under 12 years.
Interestingly the Remdesivir usage is for five days, 200 mg IV (intravenous) on day 1 followed by 100 mg IV daily for 5 days.
Convalescent plasma therapy where the plasma of the COVID-19 recovered patient that has antibodies against SARS-CoV-2 is given to the patient with COVID-19.
The protocol says the therapy may be considered in patients with moderate disease who are not improving or oxygen requirement is progressively increasing, despite use of steroids.
The protocol has set some conditions for considering convalescent plasma therapy, these include blood group compatibility, the donor of the plasma should have neutralising antibodies above certain the threshold, or the plasma IgG titer against Spike-protein should be above 1:640. Use should be avoided in patients with IgA deficiency or immunoglobulin allergyThe protocol says dose is variable ranging from 4 to 13 ml/kg or usually 200 ml single dose given slowly over not less than 2 hours
Tocilizumab, the Swiss pharma company Roche's anti-IL-6 receptor, that works as immunomodulator, is used in treating patients with autoimmune disorders like rheumatoid arthritis, has found to have some potential to control immune system going berserk in certain COVID-19 patients.
The protocol says Tocilizumab may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids. Tocilizumab, an immunomodulatory drug
The protocol says while long term safety data in COVID-19 remains largely unknown. Special considerations before its use include, presence of raised inflammatory markers like CRP, Ferritin, IL-6. Patients should be carefully monitored post Tocilizumab for secondary infections and neutropenia (fall of white blood cells). People with active infections and Tuberculosis should be ruled out before use.
The protocol says the dose should be 8mg/kg (maximum 800 mg at one time) given slowly in 100 ml NS (normal saline) over 1 hour; dose can be repeated once after 12 to 24 hours if neededHydroxychloroquine
The age old drug used in treatment of malaria, lupus has become popular with COVID-19. There are serious differences among the medical community about using this drug.But government protocol says the 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 electrocardiogram (ECG) that measures electrical activity of the heart should ideally be done before prescribing the drug to measure QTc interval. The protocol says HCQ should be avoided if the QT interval is greater than 500 milliseconds (ms).
The protocol says that HCQ has demonstrated in vitro (test tube) 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.The protocol advises a dose of 400 mg on day 1 followed by 400 mg daily for the next four days.