Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who A… (NCT05785390) | Clinical Trial Compass
TerminatedPhase 2
Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.
Stopped: The interim analysis results met protocol and SAP predetermined criteria for stopping early due to futility or efficacy.
United States170 participantsStarted 2023-02-22
Plain-language summary
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of NP-101 in treating high-risk participants who have tested positive for Covid-19. The main question\[s\] it aims to answer are:
* To evaluate the safety of NP-101, as well as establish the maximum tolerated dose in high risk Covid-19 positive patients.
Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].
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:
* Provision of signed and dated informed consent form
* A resting SpO2 of \>93% on room air.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 and over, presenting with mild to moderate clinical symptoms of Covid- 19 infection (per FDA guidance - see appendix 3) with symptom onset within 5 days prior to the day of randomization
* Positive COVID-19 infection confirmed by RT-PCR within the last 5 days of the day of randomization
* A score of ≥ 2 (moderate) on a minimum of 1 symptom on the PRO Symptom Survey on the day of randomization
* Ability to take oral medication and be willing to adhere to the dosing regimen (Twice a day - BID for 14 days)
* For females of reproductive potential: negative pregnancy test at screening and use of highly effective contraception method during study participation and for an additional 4 weeks after the end of study drug administration
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration
* Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
* To be considered high risk, participants should have at least one of the following conditions:
* age ≥60 years;
* active cancer
* chronic kidney disease;
* chronic lung disease including COPD
* O…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Establishment of MTDD
Timeframe: Fourteen days per dose (Phase IIA Only)
2
Safety and Tolerability of NP-101 vs Placebo (Phase IIa and IIb)