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

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.

Conditions

• COVID-19

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

Sponsors & Collaborators

• University of Oxford

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-30

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• Brazil
• Laos
• Nepal
• Pakistan
• Thailand

Study Locations