India to participate in WHO ''solidarity trial'' that will test 4 potential COVID-19 drugs, What it means..

New Delhi: India is soon likely to participate in the WHO''s "solidarity trial" for developing potential drugs for COVID-19, officials said on Friday.

Solidarity Trial was announced by the WHO last week as an internationa trial , which will compare the safety and effectiveness of four different drugs or drug combinations against COVID-19.

" One of the most important areas of international cooperation is research and development. A vaccine is still at least 12 to 18 months away. In the meantime, we recognize that there is an urgent need for therapeutics to treat patients and save lives." WHO DG Tedros has stated while announcing the trial.

The trials began on March 28th with  the first patient enrolled from Norway. While many drugs are being touted to show efficacy in cases of coronavirus, WHO is going to focus four most promising therapies as the part of the International trial. These include

1. An experimental antiviral compound called remdesivir;

2. The malaria medications chloroquine and hydroxychloroquine;

3 A combination of two HIV drugs, lopinavir and ritonavir;

4 and that same combination as 3 plus interferon-beta, an immune system messenger that can help cripple viruses. 

Some will be given as daily pills, and some as daily injections.

Medical Dialogues team had earlier reported that while the ICMR had approved the use of hydroxychloroquine for prophylactic use in certain cases, the DCGI has also given its nod to combination of two HIV drugs, lopinavir and ritonavir;to be used in certain cases.

The numbers however, were too less

"We are soon likely to participate in the WHO solidarity trial for developing potential drugs for COVID-19. Earlier we did not do it because our numbers were small and our contribution would have looked minuscule," Raman R Gangakhedkar, Head of Epidemiology and Communicable diseases at ICMR, said.

As per the ISRCTN registry, following will be the details of the trial 

Who can participate?

Adults (aged over 18 years) hospitalized with definite COVID-19 and not already receiving any of the study drugs. Patients invited to join the study will be those who are admitted to a collaborating hospital. It is not possible for people to volunteer themselves or their relatives to participate.

What does the study involve?

Patients diagnosed with COVID-19 and who have consented to be part of the study will be randomly allocated to receive either local standard care alone or local standard care and one of a list of study drugs. During the study, some treatments may get removed from this list, and others may be added to it. Each patient will only receive one of the treatments.

The patients will be followed up for the entire length of their hospital stay. Death from any cause will be recorded and this will be the main result used to determine whether a drug is effective. Length of hospital stay and time to first receiving ventilation (or intensive care) will also be recorded and used to determine the drug's effectiveness.

What are the possible benefits and risks of participating?

All of the drugs tested in this study are used routinely to treat other conditions and have been shown to be reasonably safe. All participants will receive the usual care for people with COVID-19 in each location as well as the study drug.

There are known side effects to each of the study medications. It is possible that unexpected serious side effects may occur as with any clinical trial of medicines. It is also possible that treatment with one or more of the test drugs worsens COVID-19 and increases the risk of severe illness or death.

It is possible that one or more of the drugs may reduce the severity of COVID-19, reduce need for ventilation, and reduce the risk of death.

For more details click on the following link

http://www.isrctn.com/ISRCTN83971151