Respiratory tract infections, COVID-19, and COVID-like illness Infections and Infestations
Conditions
Interventions
The study record was updated on 08/06/2026 with the current study interventions associated with protocol version 7 dated 10/07/2025 to improve readability:
The ECRAID-Prime trial is a platform trial w
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: The study record was updated on 08/06/2026 with the key inclusion criteria associated with protocol version 7 dated 10/07/2025 to improve readability: The generic platform inclusion criteria are listed in this section. Potential additional inclusion criteria for specific investigational products will be detailed in the relevant, approved intervention-specific appendix. In order to be eligible to participate in ECRAID-Prime, a participant must (at least) meet all the following criteria (there can be additional intervention-specific inclusion criteria): 1. 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 investigational product, then this will be described and justified in the relevant, approved intervention-specific appendix. 2. 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, or shortness of breath) and one systemic (fever, feeling feverish, sweats/chills or shivering, low energy or tiredness, headache, muscle, joint or body aches, or loss of taste and/or smell). 3. Judged by recruiting a medically qualified clinician or delegate that the illness is due to a respiratory infection. 4. Onset of symptoms less than x days (x will be specified in the relevant, approved, intervention-specific appendix). 5. Willing and able to give informed consent for participation in the study. 6. 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 relevant, approved, intervention-specific appendix The study record was updated on 13/01/2026 with the key inclusion criteria associated with protocol version 7 dated 10/07/2025: In order to be eligible to participate in ECRAID-Prime, a participant must (at least) meet all the following criteria (there can be additional intervention-specific inclusion criteria): 1. 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 investigational product, then this will be described and justified in the relevant, approved intervention-specific appendix 2. 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) 3. Judged by recruiting a medically qualified clinician or research nurse that the illness is due to COVID-19 or COVID-like illness 4. Onset of symptoms less than x days (x will be specified in the intervention-specific appendix) 5. Willing and able to give informed consent for participation in the study 6. Willing and able to comply with all trial procedures 7. Any additional eligibility criteria relevant to women of child-bearing potential, including current pregnancy or breastfeeding, will be specified in the intervention-specific appendix Previous key inclusion criteria associated with protocol version 5 dated 22/03/2024: In order to be eligible to participate in ECRAID-Prime, a participant must (at least) meet all the following cri
Exclusion criteria
Exclusion criteria: The study record was updated on 08/06/2026 with the current key exclusion criteria associated with protocol version 7 dated 10/07/2025 to improve readability: The generic exclusion criteria are listed in this section. Potential additional exclusion criteria for individual investigational products; for example, specific comorbidities or medication use, will be detailed in the relevant, approved, intervention-specific appendix A potential participant who meets any of the following criteria will be excluded from participation in ECRAID-Prime: 1. Requiring admission to the hospital on the day of inclusion 2. Known allergies or hypersensitivities to any of the components used in the formulation of the investigational product, the placebo or the comparator investigational product 3. Any disease, condition, or disorder, or language barrier that precludes participation in the trial, in the opinion of the general practitioner (GP) or delegate (with the GP serving as supervisor) checking eligibility and taking consent. 4. Any planned major surgery in the next 28 days 5. Currently participating in a trial of an investigational product 6. Any personnel involved in the study The study record was updated on 13/01/2026 with the key exclusion criteria associated with protocol version 7 dated 10/07/2025: A potential participant who meets any of the following criteria will be excluded from participation in ECRAID-Prime (there can be additional intervention-specific exclusion criteria). 1. Requiring admission to the hospital on the day of screening, or inclusion 2. Known allergies or hypersensitivities to any of the components used in the formulation of the investigational product, placebo or the comparator product 3. Any disease, condition, or disorder that precludes participation in the trial, in the opinion of the person checking eligibility and taking consent 4. Any planned major surgery in the next 28 days 5. Currently participating in a trial of an investigational product 6. Any personnel involved in the study Previous key exclusion criteria associated with protocol version 5 dated 22/03/2024: A potential participant who meets any of the following criteria will be excluded from participation in ECRAID-Prime (there can be additional intervention-specific exclusion criteria). 1. Requiring admission to the hospital on the day of screening, or inclusion 2. Known allergies or hypersensitivities to any of the components used in the formulation of the investigational product, or the control product 3. Any disease, condition, or disorder that precludes participation in the trial, in the opinion of the person checking eligibility and taking consent 4. Any planned major surgery in the next 28 days 5. Currently participating in a trial of an investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study record was updated on 08/06/2026 with the current primary outcome measures associated with protocol version 7 dated 10/07/2025 to improve readability: For Phase IIb/III-type evaluations, the primary outcome will be: Time to first self-report of feeling fully recovered from symptoms related to COVID-19 or COVID-like illness, measured in days using a daily diary for 28 days and, if not recovered within 28 days, a questionnaire at month 3. For Phase IIa-type evaluations the primary outcome parameter can be either (specified in the intervention-specific appendix): 1. Viral clearance measured from a combined nose/throat swab sample using semi-quantitative PCR on an intervention-specific appendix specified day (Day 3 for the LTX-109 evaluation) OR 2. Impact on biomarkers of illness severity, or immunological response from a blood sample using an appropriate analysis method on an intervention-specific appendix specified day The study record was updated on 13/01/2026 with the primary outcome measures associated with protocol version 7 dated 10/07/2025: The primary outcome will be phase-dependent. For Phase IIb/III-type evaluations, the primary outcome will be: 1. Time to first self-report of feeling fully recovered from symptoms related to COVID-19 or COVID-like illness (days), measured using self-report for 28 days (or month 3 if not recovered). For Phase IIa-type evaluations the primary outcome parameter will be: 2. Viral clearance measured using semi-quantitative PCR at baseline and on day 4, and impact on biomarkers of illness severity (if this will be an outcome parameter, then this will be specified in the intervention-specific appendix). The impact on biomarkers, for example, on illness severity or immunological response is dependent on the specific investigational product (also the method and timepoints are dependent on the investigational product). If this will be an outcome parameter, then this will be specified in the intervention-specific appendix o | — |
Secondary
| Measure | Time frame |
|---|---|
| The study record was updated on 08/06/2026 with the current primary outcome measures associated with protocol version 7 dated 10/07/2025 to improve readability: Key secondary outcome: early sustained recovery (recovery by day 14 sustained until day 28) Other secondary endpoints might include: 1. Sustained recovery (participants’ reported recovery that was maintained until 28 days), captured using a diary, or, if not completed, phone call at 28 days after inclusion 2. Time to first self-report of feeling recovered from symptoms of COVID-19 or COVID-like illness (for Phase IIa type evaluation) 3. Viral clearance measured using semi-quantitative PCR at ISA-specified days (Days 4, 7 and 14 for NONS and saline evaluations; Days 1 and 5 for the LTX-109 evaluation) 4. Reduction in viral load measured using digital PCR from baseline to ISA-specified days (Days 1, 3 and 5 for the LTX-109 evaluation) 5. Time to first self-report of return to usual daily activity. 6. Presence, duration, and severity of individual respiratory symptoms (runny/congested nose, sore throat, cough, fever, shortness of breath, fatigue/tiredness, sweats/chills, headache, muscle, joint and/or body aches, loss of taste/smell, diarrhoea, nausea/vomiting, and others) as absent, mild, moderate, or severe. Captured using a diary or, if not completed, phone calls at 14 and/or 28 days after inclusion. 7. Participant reported overall wellbeing, reported by rating of how well participant feels (scale 0-10) captured using a diary, or, if not completed, phone calls at 14 and/or 28 days after inclusion. 8. Overall safety of the IP by reporting (serious) adverse drug reactions captured using a diary or, if not completed, phone calls at 14 and/or 28 days after inclusion. 9. Tolerability of the IP, via reasons for stopping IP intake captured using a diary or, if not completed, phone calls at 14 and/or 28 days after inclusion. 10. The use of additional antiviral medication (yes/no, name of medication) captured usin | — |
Countries
Belgium, France, Georgia, Germany, Ireland, Poland, Spain, United Kingdom
Contacts
Public ContactLina Gurskaite
Outcome results
None listed