Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Inf… (NCT04896853) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®
Sweden9 participantsStarted 2021-05-18
Plain-language summary
To investigate the safety and tolerance of a single infusion of ProTrans® in subjects with "severe" respiratory complications associated with pneumonia caused by COVID-19, Influenza A, Metapneumovirus or RSV infection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hormonal contraception may be susceptible to interaction with the Investigational Medicinal Products (IMP), which may reduce the efficacy of the contraception method
. Contraception methods that in the context of this guidance are considered to have low user dependency.
. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success. 4 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to test the safety and tolerability of a single infusion of ProTrans® — not yet to prove it works — what does that mean for my realistic expectations if I were to participate?
2This trial covers several different respiratory infections including COVID-19 ARDS, influenza A, metapneumovirus, and RSV — given my specific diagnosis, do you think my situation actually fits what this study is designed to address?
3The trial is listed as 'active not recruiting,' which means they are no longer enrolling new patients — does that mean this option is effectively closed to me, or is there any pathway to access ProTrans® outside the trial?
4ProTrans® is being given as a single infusion — can you walk me through what is known so far about how that infusion is administered, what monitoring would be involved, and what side effects have been observed in early participants?
5Before considering an experimental Phase 1 treatment like this, are there standard-of-care options for my condition that we should try first, and how would participating in a trial like this affect access to those alternatives?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerance of a single infusion of ProTrans®