Study of the Safety, Tolerability and Efficacy of NP-101 in Treating High Risk Participants Who Are Covid-19 Positive.
NCT05785390 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-05-22
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 \[insert effects\].
Conditions
Interventions
- DRUG
-
NP-101
NP-101 is an organically derived, GMP manufactured product covered under IND #152687.
- OTHER
-
Placebo
Identical placebo
Sponsors & Collaborators
-
Novatek Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Ahmed Kaseb, MD · Novatek Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-22
- Primary Completion
- 2025-05-09
- Completion
- 2025-05-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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