Investigational therapies off-label remedy

Doctors caution that plasma therapy is not a silver bullet to treat Covid patients as there is no clear mortality benefit of it

By   |  Published: 10th Aug 2020  12:11 amUpdated: 9th Aug 2020  11:53 pm
The recommendations on investigational therapies are not based on proven clinical trials but are based on consensus of experts

Hyderabad: Investigational therapies meant for coronavirus positive patients have now become a major feature at all private hospitals in Telangana. Widespread and repeated sharing of their ‘so called benefits’ in treating Covid-19 positive cases across social media platforms has created so much hype that patients and their relatives expect doctors to prescribe such therapies.

The demand is so much that the managements of government hospitals in the State also have started to stock medicines, which are yet to undergo extensive scrutiny including Randomised Control Trials (RCT), to ascertain the efficacy of the drug in treating the medical condition.

What are investigational therapies for Covid-19?

The Ministry of Health and Family Welfare in its National Clinical Protocols for Management of Covid-19’ document has talked about some potential off-label or investigational use of medications for Covid-19 treatment.

These recommendations on investigational therapies are not based on proven clinical trials but are based on consensus of experts along with available evidence. Under investigational therapies, the Ministry has included Remdesivir, Convalescent Plasma and Tocilizumab therapies that could be administered to patients. However, “an informed and shared decision making is essential before prescribing any of these therapies,” the Ministry has clarified.

Convalescent Plasma

Among all the investigational therapies, perhaps convalescent plasma therapy has become a modality that people perceive as a silver bullet for treatment of Covid-19 patients. “It is not a silver bullet to treat patients. Recently, AIIMS, New Delhi, made it very clear through their studies that plasma therapy does not show benefit in reducing mortality risk among Covid-19 patients. Hospitals and care givers must be cautious in pushing this therapy, which triggers sky-high expectations among the patients and their relatives,” said Director of Public Health, Dr G Srinivas Rao while interacting with press persons on Saturday.



What does AIIMS say on plasma therapy?

The AIIMS, New Delhi conducted a RCT on plasma therapy in 30 patients and according to its Director, Dr Randeep Guleria, no clear mortality benefit of plasma therapy was seen during the trial on 30 Covid-19 positive patients.

Plasma therapy involves taking antibodies from the blood of a recovered person and transfusing them into active coronavirus infected patients. “There are certain criteria for administering plasma therapy and it can’t be given to severe cases on ventilators. We urge the public to be cautious in hyping this therapy,” Director of Medical Education, Dr K Ramesh Reddy said.

Remdesivir and Tocilizumab

Both these drugs have become quite noted and are in huge demand among Covid-19 patients and their relatives. However, 85 per cent of the positive patients do not need to be administered both these drugs. In fact, the State has banned the retailing of these two drugs at drug stores and they are made directly available to the designated Covid-19 hospital from distributors.

Remdesivir is an antiviral injection, which is not at all effective for patients who are on ventilators but is believed to be helpful for moderate patients on oxygen support quickly. The Tocilizumab is an immunosuppressant which is the only experimental or investigational therapy for patients on ventilators.

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