RecruitingPhase 2NCT05041907

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)


Sponsor

University of Oxford

Enrollment

3,800 participants

Start Date

Sep 30, 2021

Study Type

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atilotrelvir/ritonavir, a drug called Ensitrelvir, and others for people with covid-19. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNirmatrelvir/ritonavir (e.g. PAXLOVID™)

Nirmatrelvir 300mg BD for 5/7 Ritonavir 100mg BD for 5/7

DRUGNitazoxanide

Nitazoxanide 1.5g BD 7/7

DRUGMolnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™)

Molnupiravir 800mg BD for 5/7, Nirmatrelvir 300mg BD for 5/7, Ritonavir 100mg BD for 5/7

DRUGHydroxychloroquine

Hydroxychloroquine 400mg D0 BD and 400MG OD for a further 6/7

OTHERNo treatment

No treatment (except antipyretics- paracetamol)

DRUGMonoclonal antibodies

Monoclonal antibodies: 300mg tixagevimab/ 300 mg cilgavimab given once on D0

DRUGFluoxetine

Fluoxetine 40mg OD for 7/7

DRUGMolnupiravir

Molnupiravir 800mg BD for 5/7

DRUGSotrovimab

Sotrovimab 500mg given once on D0

DRUGEnsitrelvir

Ensitrelvir 375mg OD D0 and 125mg OD for a further 4/7

DRUGMonoclonal antibodies

Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0

DRUGFavipiravir

Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7

DRUGIvermectin

Ivermectin 600micrograms/kg/day for 7/7.

DRUGRemdesivir

Remdesivir 200mg D0 and 100mg for a further 4/7.

DRUGAtilotrelvir/ritonavir

Atilotrelvir 150mg BD for 5/7 Ritonavir 100mg BD for 5/7

DRUGMetformin

Metformin 500mg TDS 5/7

DRUGNirmatrelvir/ritonavir

Nirmatrelvir 300mg BD for 5/7 Ritonavir 50mg BD for 5/7

DRUGNirmatrelvir/ritonavir

Nirmatrelvir 150mg BD for 5/7 Ritonavir 50mg BD for 5/7

DRUGNirmatrelvir

Nirmatrelvir 300mg BD for 5/7


Locations(7)

Universidade Federal de Minas Gerais

Minas Gerais, Brazil

Laos-Oxford-Mahosot Wellcome Trust Research Unit

Vientiane, Laos

Sukraraj Tropical & Infectious Disease Hospital

Kathmandu, Nepal

The Aga Khan University Hospital

Karachi, Pakistan

Vajira hospital

Bangkok, Thailand

Faculty of Tropical Medicine, Mahidol University

Bangkok, Thailand

Bangplee Hospital

Mueang Samut Prakan, Thailand

View Full Details on ClinicalTrials.gov

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NCT05041907


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