CTIS2022-501707-27-01Active, not recruitingPhase 1
European Clinical Research Alliance on Infectious Diseases – primary care adaptive platform trial for pandemics and epidemics (ECRAID-Prime) - EU-EcraidPC-1
niversity Medical Center Utrecht0 sites1,001 target enrollmentStarted: January 31, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,001
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Participant is =18 years of age on the day of inclusion; if people aged <18 years are suitable for inclusion in the evaluation of an IP, then this will be described and justified in the relevant intervention specific appendix, Presence of at least two symptoms suggestive of COVID-19 or COVID-like-illness, one respiratory (cough, sore throat, running or congested nose or sinuses, shortness of breath) and one systemic (fever, feeling feverish, sweats/chills or shivering, low energy or tiredness, headache, muscle, joint or body aches, loss of taste and/or smell)., Judged by recruiting medically qualified clinician or delegate that the illness is due to a respiratory infection, Onset of symptoms less than 7 days (in case earlier treatment is required for a specific IP, this will be specified in the intervention specific appendix)., Willing and able to give informed consent for participation in the study, Willing and able to comply with all trial procedures (including availability of freezer at participant’s home to store self-collected swabs)., Any additional eligibility criteria relevant to women of child-bearing potential, including current pregnancy or breastfeeding will be specified in the ISA. Participants of childbearing potential are defined as participants who are potentially fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. Highly effective contraception methods include sterilisation, combined oestrogen and progestogen containing hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner (provided that partner is the sole sexual partner of the WOCBP trial participant, and that the vasectomised partner has received medical assessment of the surgical success). If women have been abstinent for the 30 days before enrolling in the trial and will agree to continue to be abstinent for a further 30 days after the end of IP intake, where this is in line with their preferred and usual lifestyle, this would also count as effective contraception, Intervention specific: Onset of symptoms within 3 days, Intervention specific: For women of Child bearing potential, prepared to use an effective method of contraception or abstinence for 30 days before and after inclusion.
Exclusion Criteria
- •Requiring admission to the hospital on the day of inclusion., Intervention specific: Using any NO donor agents (i.e. prilocaine, sodium nitroprusside, nitroglycerine, amyl nitrite, isosorbide dinitrate, isosorbide 5-mononitrate and nicorandil) within 7 days before screening, Known allergies or hypersensitivities to any of the components used in the formulation of the IP, or the control product., Any disease, condition, or disorder, or language barrier that precludes participation in the trial, in the opinion of the person GP or delegate checking eligibility and taking consent., Any planned major surgery in the next 28 days., Currently participating in a trial of a pharmacological treatment., Intervention specific: Known to be currently pregnant or breastfeeding, Intervention specific: Current of history of moderate to severe epistaxis or hereditary hemorrhagic telangiectasia, Intervention specific: History of cerebral spinal fluid leaks via the sinuses/nose, Intervention specific: Recent nasal fracture, nasal tumors, nasal masses, meningoencephalocele, and/or nasal surgery within the previous 2 weeks
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