Nirmatrelvir/ritonavir (e.g. PAXLOVID™): Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7
Nitazoxanide: Nitazoxanide 1.5g BD 7/7
Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™): Molnupiravir 800mg BD for 5/7, Nirmatrelvir 300mg BD for 5/7, Ritonavir 100mg BD for 5/7
Hydroxychloroquine: Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7
No treatment: No treatment (except antipyretics- paracetamol)
Monoclonal antibodies: Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0
Fluoxetine: Fluoxetine 40mg OD for 7/7
Molnupiravir: Molnupiravir 800mg BD for 5/7
Sotrovimab: Sotrovimab 500mg given once on D0
Ensitrelvir: Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7
Monoclonal antibodies: Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0
Favipiravir: Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7
Ivermectin: Ivermectin 600micrograms/kg/day for 7/7.
Remdesivir: Remdesivir 200mg D0 and 100mg for a further 4/7.
Atilotrelvir/ritonavir: Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7
Metformin: Metformin 500mg TDS 5/7
Nirmatrelvir/ritonavir: Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir/ritonavir: Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7
Nirmatrelvir: Nirmatrelvir 300mg BD for 5/7
Study 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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
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
Primary outcome measure(s)
Rate of viral clearance for interventions relative to the no study arm (This is a superiority comparison) — Days 0-5 Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for each intervention compared with the no antiviral treatment control i.e., those not receiving study drug
Rate of viral clearance for interventions relative to the positive control arm (This is a non-inferiority or superiority comparison). — Days 0-5 Rate of viral clearance- estimated from the log10 viral density derived from qPCR of standardised duplicate oropharyngeal swabs/ saliva taken daily from baseline (day 0) to day 5 for interventions compared with the current best antiviral treatment option (accelerated viral clearance relative to the positive control arm)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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