From UPSC perspective, the following things are important :
Prelims level : FAITH and Solidarity Trials
Mains level : Clinical trials and ethical issues involved
With the number of COVID-19 patients rising in India, a pharma company has announced a new randomized study to test the combined efficacy of two antiviral drugs under the ‘FAITH Trials’.
Misleading names: One may get confused over the names given to these clinical trials. The name ‘FAITH’ and ‘Solidarity’ appear more like a judicial trial or some Human Rights violation related trials. UPSC can knock such areas in prelims.
- The two drugs: Favipiravir and Umifenovir will be tried as a potential COVID-19 treatment strategy.
- This new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy and safety) Trial in Indian Hospital setting).
- The two antiviral drugs have different mechanisms of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during the early stages of the disease.
- This trial offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus.
Dosages under the trial
- Patients taking the drug will receive Faviprivir 1800 mg bid and Umifenovir 800 mg bid on Day 1.
- Thereafter, they will receive Faviprivir 800mg bid and Unifenovir 800mg bid for the remaining course of treatment.
- Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests.
- While one group will be receiving Favipiravir and Umifenovir (with standard supportive care), the other group will receive Favipiravir along with standard supportive care.
Other trials in news: The Solidarity Trial
- “Solidarity” is an international initiative for clinical trials launched by the WHO, along with partners, to help find an effective treatment for Covid-19.
- It was originally supposed to look at four drugs or drug combinations: Remdesivir, HCQ, Ritonavir/Lopinavir and Lopinavir/Ritonavir/Interferon beta 1a.
- Now with HCQ trial enrolment stalled for at least the next few weeks, the Solidarity trial will proceed with the other three arms.