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

  • STATUS
    Recruiting
  • End date
    Aug 21, 2023
  • participants needed
    750
  • sponsor
    University of Oxford
Updated on 21 March 2022

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. In this randomised 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. potentially effective repurposed antiviral drugs;
  2. Positive control: we will initially include the REGN-COV2 (monoclonal antibody cocktail); and later:
  3. any future small molecule drugs that pass phase 1 testing.

PLATCOV study is funded by ACT-Accelerator Therapeutics Partnership through the Wellcome Trust. The grant reference number is 223195/Z/21/Z

Description

The platform trial will assess drugs with potential SARS-CoV-2 antiviral activity of three general types:

  1. Repurposed potential antiviral drugs (initially from: hydroxychloroquine, ivermectin, lopinavir-ritonavir, miglustat, remdesivir, nitazoxanide, nebulised unfractionated heparin (UFH), favipiravir)

Repurposed drugs are already recommended in some countries. Showing that they do not have a significant antiviral activity is as important as showing that they do.

B. Positive control: monoclonal antibody initially

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. Monoclonal antibodies are expensive and cannot be produced at large scale currently, but this may change in the near future.

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. Randomisation ratios will be uniform across all available treatment arms of type A and B and the control arm in each site. Once interventions of type C (novel drugs) are added to the platform, response adaptive randomisation will apply ("pick the winner").

Details
Condition COVID-19
Treatment No Treatment, Ivermectin, Favipiravir, Remdesivir, Monoclonal antibodies, Monoclonal antibodies
Clinical Study IdentifierNCT05041907
SponsorUniversity of Oxford
Last Modified on21 March 2022

Eligibility

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note