Objective: This report presents an overview on the progress of clinical trials in Indonesia based on database assessment from clinical trial registries.Methods: Study records that were registered up to December 26, 2018, were extracted from three clinical trial registries (ClinicalTrials.gov, ISRCTN registry, and EudraCT) and a clinical trial register (WHO International Clinical Trials Registry Platform (ICTRP)) with the keyword "Indonesia". A total of 505 records comprised of 402 interventional studies and 103 observational studies were found and analyzed. Results: The top five noncommunicable diseases (NCDs) studied were cancers, diabetes, cardiac diseases, hypertension, and gastrointestinal diseases, while the top five infectious diseases (IDs) were malaria, tuberculosis, vaccines for IDs, HIV, and dengue. Remarkably, the proportion of regional studies (within Indonesia only) was higher than that of multiregional studies (including areas outside of Indonesia) in general. This trend became most apparent after the issuance of national regulations on Material Transfer Agreements (MTA) and other rules. Upon closer scrutiny, regional clinical trials and multiregional clinical trials (MRCTs) in Indonesia differed in terms of sponsorship, target population and size, interventions, and study phases. Conclusions: The total number of clinical trials in Indonesia is increasing and is mainly attributed to the growing number of regional clinical trials sponsored from within the country. Interrelated factors have shaped the characteristics of these as compared to the dwindling number of MRCTs. Establishment of a national level of management is an option that can better facilitate both MRCTs as well as regional clinical trials, to better address the national health issues, and to cope with the regulations.

The COVID-19 pandemic has caused millions of deaths and hundreds of millions of confirmed infections worldwide. This pandemic has prompted researchers to produce medications or vaccines to reduce or stop the progression and spread of this disease. A variety of previously licensed and marketed medications are being tested for the treatment and recurrence of SARS-CoV2, including favipiravir (Avigan). Favipiravir was recognized as an influenza antiviral drug in Japan in 2014, and has been known to have a potential in vitro activity against SARS-CoV-2, in addition to its broad therapeutic safety scope. Favipiravir was recently approved and officially used in many countries worldwide. Our review provides insights and up-to-date knowledge of the current role of favipiravir in the treatment of COVID-19 infection, focusing on preclinical and ongoing clinical trials, evidence of its efficacy against SARS-CoV-2 in COVID-19, side effects, anti-viral mechanism, and the pharmacokinetic properties of the drug in the treatment of COVID-19. Due to its teratogenic effects, favipiravir cannot be offered to expectant or pregnant mothers. The practical efficacy of such an intervention regimen will depend on its dose, treatment duration, and cost as well as difficulties in application.