BridgeMD
Clinical trial for the treatment of COVID-19 and COVID-like illness in primary care
EU CTIS ID: 2022-501707-27-01
What this study is testing
The primary objective(s) of this platform study will be phase dependent. To assess the efficacy of the study IP versus control (Usual Care) or versus a comparator (placebo, or comparator IP) on: - Time to first self-report of feeling recovered from symptoms of COVID-19 or COVID-like-illness (for Phase IIb/III type evaluation, as specified in the relevant intervention specific appendix). - Viral clearance and potentially viral load and/or impact on biomarkers, for example on illness severity or immunological response (for Phase IIa type evaluation as specified in the relevant intervention specific appendix). For ISA A/B/C the primary objective is as per master protocol. For ISA D the primary objective will be: - Viral clearance by LTX-109 nasal spray (0.5% w/w) measured at Day 3 after inclusion as compared to placebo nasal spray (0% LTX-109).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- NONS and SN Spray specific: For women of Child bearing potential, prepared to use an effective method of contraception or abstinence for 30 days before and after inclusion.
- NONS and SN Spray specific: For women of child-bearing potential, a negative urine pregnancy test.
- LTX-109 specific: Inclusion within 3 days since onset of respiratory symptoms
- 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
You likely can't join if
- Requiring admission to the hospital on the day of inclusion.
- Any planned major surgery in the next 28 days.
- Currently participating in a trial of a pharmacological treatment.
- NONS and SN Spray specific: Known to be currently pregnant or breastfeeding
- NONS and SN Spray specific: Known glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- NONS and SN Spray specific: Current of history of moderate to severe epistaxis or hereditary hemorrhagic telangiectasia
See the full eligibility 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
- NONS and SN Spray specific: For women of Child bearing potential, prepared to use an effective method of contraception or abstinence for 30 days before and after inclusion.
- NONS and SN Spray specific: For women of child-bearing potential, a negative urine pregnancy test.
- LTX-109 specific: Inclusion within 3 days since onset of respiratory symptoms
- 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 x days (x will be specified in the ISA
- 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 (WOCBP), 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 of heterosexual sex for the 30 days before enrolling in the trial and will agree to continue to be abstinent of heterosexual sex 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
- NONS and SN Spray specific: Onset of symptoms within 3 days
- Requiring admission to the hospital on the day of inclusion.
- Any planned major surgery in the next 28 days.
- Currently participating in a trial of a pharmacological treatment.
- NONS and SN Spray specific: Known to be currently pregnant or breastfeeding
- NONS and SN Spray specific: Known glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- NONS and SN Spray specific: Current of history of moderate to severe epistaxis or hereditary hemorrhagic telangiectasia
- NONS and SN Spray specific: History of cerebral spinal fluid leaks via the sinuses/nose
- Any personnel involved in the study
- NONS and SN Spray specific: Recent nasal fracture, nasal tumors, nasal masses, meningoencephalocele, and/or nasal surgery within the previous 2 weeks
- LTX-109 specific: Any known nasal anatomical anomalies
- NONS and SN Spray specific: Using any of the contradicted agents within 7 days before screening: o NO donors/derivatives: isosorbide dinitrate, isosorbide mononitrate, nitroglycerine/glyceryl trinitrate, nitroprusside, nicorandil. o Phosphodiesterase inhibitors: avanafil, sildenafil, tadalafil, vardenafil. o Guanylate cyclase activators: riociguat, linaclotide.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.