Platform Randomised trial of INterventions against COVID-19 In older peoPLE - PRINCIPLE
Participant Registration
Screening Form
Thank you for considering participating in the PRINCIPLE trial.
If you have not already read the Participant Information Leaflet you can download it by clicking the link below.
Click here to download the PRINCIPLE Participant Information Leaflet
There is also an illustrated summary of the Participant Information Leaflet that you can download by clicking the link below:
Click here to download an illustrated summary of the PRINCIPLE Participant Information Leaflet
Click here to access translated versions of the PRINCIPLE Participant Information Leaflet
To start your registration, please complete this screening form.
After you have answered all the questions on this form
please click the "Submit" button at the bottom of the page to proceed to your Consent Form
Please select your age range
Are you willing to give informed consent for participation in the study?
Do you have a new continuous cough, and/or high temperature, and/or a loss of or change in your normal taste or sense of smell, which have been present for less than 15 days?

Defined:
A new continuous cough - this means coughing a lot for more than an hour, or 3 or more coughing episodes in 24 hours (if you usually have a cough, it may be worse than usual)
and/or
A high temperature - this means you feel hot to touch on your chest or back
(you do not need to take your temperature)

What date did you start to feel unwell with this illness?
- -
Are you feeling almost recovered from this illness?
(i.e. generally much improved and your symptoms are now mild or almost absent)
Have you had a positive test for COVID-19 infection?
What date was this COVID-19 test taken?
- -
Are you unwell with symptoms of COVID-19?
These symptoms may include, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, diarrhoea and vomiting.
What date did you start to feel unwell with this illness?
- -
Are you feeling almost recovered from this illness
(i.e. generally much improved and your symptoms are now mild or almost absent)?

Do you have at least one of the comorbidities/conditions listed below?

  • Weakened immune system due to a serious illness or medication (e.g. chemotherapy)
  • Heart disease or high blood pressure
  • Asthma or lung disease
  • Known diabetes
  • Liver disease
  • Stroke or neurological problem

Do you have a body mass index (BMI) at or above 35 kg/m2?

Click here if you need to calculate your BMI

Are you experiencing shortness of breath as part of a Covid-19 illness?

Shortness of breath can make it hard to breathe deeply and you may feel winded or as if you can’t get enough air into your lungs. Unlike many other conditions that cause shortness of breath, this symptom can persist and quickly escalate in people with COVID-19.
Are you currently admitted in hospital?
Have you previously participated in the PRINCIPLE trial?
Are you a pre-menopausal female that is capable of becoming pregnant?

Are you using a highly effective method of contraception* and prepared to use this for the 28 days of the study?

* The implant, the coil and male or female sterilisation will be acceptable for participating in the trial. The injection and most forms of hormonal contraception will also be considered acceptable for the trial, if used in combination with condoms or other barrier methods. However, condoms alone won’t be sufficient during the study.
You can discuss any questions you have about contraception during the study period with the trial team.
Are you pregnant or planning on becoming pregnant within the next few weeks?
Are you breastfeeding or planning on starting during the course of the trial?
Do you have a female sexual partner who is pre-menopausal and capable of becoming pregnant?

Is your female sexual partner using a highly effective method of contraception* and prepared to use this for the 28 days of the study?

* The implant, the coil, and male or female sterilisation will be acceptable for participating in the trial. The injection and most forms of hormonal contraception will also be considered acceptable for the trial, if used in combination with condoms or other barrier methods. However, condoms alone won’t be sufficient during the study.
You can discuss any questions you have about contraception during the study period with the trial team.

Are you hypersenitive/allergic to any of the following:

  • Colchicine
  • Lactose
  • Pregelatinised Maize Starch
  • Stearic Acid
  • Purified Water
  • Ethanol (96%)
Do you have a known blood disorder that requires regular hospital appointments?
Do you have a known severe kidney impairment or require dialysis?
Do you have severe liver disease?

Are you currently taking any of the following drugs

  • Clarithromycin
  • Cobicistat
  • Colchicine
  • Cyclosporin
  • Diltiazem
  • Disulfiram
  • Erythromycin
  • HIV protease inhibitors (e.g. ritonavir, atazanavir)
  • Itraconazole
  • Ketoconazole
  • Quinidine
  • Verapamil
  • Voriconazole
Are you willing to not eat or drink grapefruit juice for 14 days?
Do you have inflammatory bowel disease or chronic diarrhoea?
Do you have a known allergy to favipiravir?
Are you currently taking favipiravir?
Do you have a known history of gout?
Where did you hear about the trial?
If other, please specify
After you have answered all the questions on this form and clicked "I'm not a robot" below
please click the "Submit" button at the bottom of the page to proceed to your Consent Form
PRINCIPLE Participant Registration v14.0 22-03-2021
REC Number: 20/SC/058, IRAS Number: 281958, EudraCT Number: 2020-001209-22, Chief Investigator: Professor Christopher Butler