NIH20–0006
Adaptive COVID-19 Treatment Trial (ACTT) is an adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults with COVID-19. It is initiated by the National Institutes of Health (NIH) in the United States with Singapore as one of the participating countries. Each new intervention, which is introduced according to scientific and public health needs, represents a new stage of ACTT.
COVID-19 situation was evolving rapidly in early 2020 and the main focus was to initiate the ACTT as soon as possible to enable access to new treatment for patients in Singapore. To support this urgent national needs, Singapore Clinical Research Institute (SCRI) was engaged to help with the local initiation of the study, which was instrumental to accelerate the trial start-up. The study activation was eventually accomplished in one month. The 1st Singapore patient was successfully enrolled in ACTT-1 on 25 March 2020. With the continuous support from SCRI project management, the study has achieved the stage target for ACTT-1, ACTT-2, ACTT-3 and ACTT-4 successively.
In addition, SCRI project management facilitated the ACTT network local expansion. The involvement of Singapore has been expanded from the initial 1 site to 6 hospitals as of today. Being part of ACTT network enabled young hospitals like NTFGH, AH and SKH to develop the required manpower and operation workflow for ID research.
The efforts from the Singapore sites in supporting ACTT were credited by the authorship offered by NIH in NEJM publications (impact factor 74.699). Given the preliminary results about remdesivir from ACTT-1, the Food and Drug Administration issued an Emergency Use Authorization on May 1, 2020 (modified on August 28, 2020), to permit the use of remdesivir for treatment in adults and children hospitalized with suspected or laboratory- confirmed Covid-19. Remdesivir has also received conditional approval in Singapore by HSA since 10 Jun 2020.
Participating ACTT enriched the local experience of initiating treatment trials in urgent needs in expeditious manner. The collaborations with NIH also helped the local team to gain knowledge on how a multi-site, global clinical trial platform is efficiently managed to ensure the high-quality study conduct in meeting FDA standards. In addition, being part of ACTT network enabled young local site like NTFGH, AH and SKH to develop the required manpower and operation workflow for ID research. All these positive experiences are instrumental for Singapore to be better armed for future needs in pandemic circumstances.