Finding treatments for COVID-19: A phase 2 multi-centre adaptive platform trial to assess antiviral pharmacodynamics in early symptomatic COVID-19 (PLATCOV)
PLATCOV is a phase 2 platform study assessing antivirals in early COVID-19 disease. It is looking for sites with the below characteristics to be able to rapidly set up and recruit into this platform trial within 4 months, for an 18-month period. The study is run out of the Mahidol Oxford Tropical Medicine Research Unit in Bangkok, Thailand, led by Professor Sir Nicholas White, chair of the coalition’s Steering Committee, and sponsored by the University of Oxford. The study has funding and is ready to begin.
- Outpatient ward where COVID-19 patients can be safely screened and be given parenteral medications (ideally a dedicated Clinical Trials Unit)
- Dynamic, independent, and proactive team able to identify patients early in the disease
- Experience in the conduct of clinical trials, including computer-based data entry systems and intensive blood sampling for pharmacokinetic/pharmacodynamic assessments
- Ability to rapidly assemble a dedicated research team to meet the study objectives, including daily patient review for the first 7 days (at the ward or at home for those on oral medications), ideally within 2 months. (Site dependent but site team includes study Nurses, a Physician, Study coordinator, laboratory personnel to process samples- all ideally vaccinated and experienced in use of PPE)
- Knowledge and experience of local and national Ethics and Regulatory procedures to lead on getting submissions ready and approved in a rapid timeframe (3 months)
- On-site laboratory facilities with access or space for a -80°C freezer, with expertise in PCR (ideally quantitative RT-PCR) and access to basic blood testing facilities incl. FBC and biochemistry. Have qPCR set up and quality-assured within 3 months.
- Local transmission and infection in the eligible adult population which will allow for the recruitment of c. 250 patients, with early COVID-19 (less than 4 days of symptoms), absence of co-morbidities and less than 50 years old
- Ability to admit and assess patients overnight if needed
- Ability to comply with applicable MORU and University of Oxford policies and procedures
- Adequate and robust reporting (including financial) structures and mechanism
- Ability to sign a study agreement and meet the required terms and conditions
- Experience in conducting Phase I/ II clinical studies