Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
University of Oxford
3,800 participants
Sep 30, 2021
INTERVENTIONAL
Conditions
Summary
The trial will develop and validate a platform for quantitative assessment of antiviral effects in low-risk patients with high viral burdens and uncomplicated COVID-19 to determine in-vivo antiviral activity. In this randomized open label, controlled, group sequential adaptive platform trial, we will assess the performance of three distinct types of intervention relative to control (no treatment): A: Small molecule drugs; B: Monoclonal antibodies; C: Dose finding for the constituent parts of nirmatrelvir/ritonavir PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.
Eligibility
Inclusion Criteria7
- Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study.
- Previously healthy adults, male or female, aged 18 to 60 years at time of consent with early symptomatic COVID-19
- SARS-CoV-2 positive by lateral flow antigen test OR a positive PCR test for SARS-CoV-2 within the last 24hrs with a Ct value of less than 25 (all viral targets)
- Symptoms of COVID-19 (including fever, or history of fever) for less than 4 days (96 hours).
- Oxygen saturation ≥96% measured by pulse-oximetry at time of screening.
- Able to walk unaided and unimpeded in ADLs
- Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits
Exclusion Criteria9
- The patient may not enter the study if ANY of the following apply:
- Taking any concomitant medications or drugs (see appendix 4)†
- Presence of any chronic illness/ condition requiring long term treatment, or other significant comorbidity (e.g. diabetes, obesity but see appendix 4 for the full list)
- Laboratory abnormalities discovered at screening (see appendix 4)
- For females: pregnancy, actively trying to become pregnant, or lactation
- Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics (see appendix 4)
- Currently participating in another COVID-19 therapeutic or vaccine trial
- Evidence of pneumonia (although imaging is NOT required)
- healthy women on the oral contraceptive pill are eligible to join the study
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Interventions
Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7
Nitazoxanide 1.5g BD 7/7
Molnupiravir 800mg BD for 5/7, Nirmatrelvir 300mg BD for 5/7, Ritonavir 100mg BD for 5/7
Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7
No treatment (except antipyretics- paracetamol)
Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0
Fluoxetine 40mg OD for 7/7
Molnupiravir 800mg BD for 5/7
Sotrovimab 500mg given once on D0
Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7
Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0
Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7
Ivermectin 600micrograms/kg/day for 7/7.
Remdesivir 200mg D0 and 100mg for a further 4/7.
Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7
Metformin 500mg TDS 5/7
Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir 300mg BD for 5/7
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05041907