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RECRUITING
NCT05041907
PHASE2

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Sponsor: University of Oxford

View on ClinicalTrials.gov

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.

Official title: Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3800

Start Date

2021-09-30

Completion Date

2027-01

Last Updated

2026-02-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Nirmatrelvir/ritonavir (e.g. PAXLOVID™)

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

DRUG

Nitazoxanide

Nitazoxanide 1.5g BD 7/7

DRUG

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

DRUG

Hydroxychloroquine

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

OTHER

No treatment

No treatment (except antipyretics- paracetamol)

DRUG

Monoclonal antibodies

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

DRUG

Fluoxetine

Fluoxetine 40mg OD for 7/7

DRUG

Molnupiravir

Molnupiravir 800mg BD for 5/7

DRUG

Sotrovimab

Sotrovimab 500mg given once on D0

DRUG

Ensitrelvir

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

DRUG

Monoclonal antibodies

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

DRUG

Favipiravir

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

DRUG

Ivermectin

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

DRUG

Remdesivir

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

DRUG

Atilotrelvir/ritonavir

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

DRUG

Metformin

Metformin 500mg TDS 5/7

DRUG

Nirmatrelvir/ritonavir

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

DRUG

Nirmatrelvir/ritonavir

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

DRUG

Nirmatrelvir

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