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

  • End date
    Aug 14, 2024
  • participants needed
  • sponsor
    University of Oxford
Updated on 7 October 2022


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):

  1. Newly available and repurposed potential antiviral drugs; B: Positive control: monoclonal antibodies initially but subsequently any therapeutic that is shown to accelerate the rate of viral clearance C: Novel small molecule drugs that have gone through phase 1 testing

PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.


The platform trial will assess drugs with potential SARS-CoV-2 antiviral

Activity of three general types:

  1. Newly available and repurposed potential antiviral drugs. (initially from: hydroxychloroquine, ivermectin, lopinavir-ritonavir, miglustat, remdesivir, nitazoxanide, nebulized unfractionated heparin (UFH), favipiravir, Molnupiravir, Nirmatrelvir/ritonavir (e.g. PAXLOVID™), Fluoxetine, Fluvoxamine, AZD7442 (Evusheld),ensitrelvir, and a combination of Molnupiravir and Nirmatrelvir/ritonavir (e.g. PAXLOVID™)

Newly available and repurposed drugs are already used and recommended in some countries. Showing that they do not have significant antiviral activity is as important as showing that they do. For the newly approved antivirals, comparing antiviral activities in- vivo will inform health authorities' recommendations.

B. Positive control: monoclonal antibodies initially (e.g. casirivimab/imdevimab) but subsequently any therapeutic that is shown to accelerate the rate of viral clearance

Monoclonal antibodies are vulnerable to viral escape mutations. Tracking their performance over time is important to characterise the impact and inform the therapeutics of mutant SARS-CoV-2 strains. This will also be important for other antivirals. Monoclonal antibodies are expensive and cannot be produced at large scale currently, but this may change in the near future. These drugs may not be available early in the study, and will be included if there is local availability and regulatory approval.

C. Novel small molecule drugs that have gone through phase 1 testing Each site will include a negative control arm consisting of patients not receiving any study drug except for antipyretics- paracetamol. At any given time in the study, it is possible that not all intervention arms are available.

Randomization to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomization ratios will be uniform for all available interventions.

Recruitment onto the ivermectin arm was stopped on April 18th 2022 due to meeting the predefined stopping criteria.

Recruitment onto the remdesivir arm was stopped on June 10th 2022 due to meeting the predefined stopping criteria.

Condition COVID-19
Treatment No Treatment, Fluoxetine, Nitazoxanide, Ivermectin, Favipiravir, Remdesivir, Molnupiravir, Monoclonal antibodies, Monoclonal antibodies, Nirmatrelvir/ritonavir (e.g. PAXLOVID™)
Clinical Study IdentifierNCT05041907
SponsorUniversity of Oxford
Last Modified on7 October 2022


Yes No Not Sure

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 50 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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