Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04458298 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
A Phase 2 study, sponsored by Ashvattha Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT04458298 is a Phase 2 study that was terminated before completion, run by Ashvattha Therapeutics. The registered enrollment target is 28 participants.
The verdict
NCT04458298, a Phase 2 study, was terminated before completion, sponsored by Ashvattha Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients. A further secondary objective of Stage 2 of this study is: To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.
Interventions
- DRUG Placebo
- DRUG OP-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04458298
The ClinicalTrials.gov registry entry for NCT04458298 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ashvattha Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04458298 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04458298 about?
NCT04458298 is a clinical study titled "A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients". The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19. The secondary purpose of Stage 1 and Stage 2 of this study is to de...
What is the current status of trial NCT04458298?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2020-08-11. Estimated completion is 2022-08-12.
What interventions are being tested in trial NCT04458298?
The interventions under investigation include: Placebo (DRUG), OP-101 (DRUG).
Who is sponsoring clinical trial NCT04458298?
This trial is sponsored by Ashvattha Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.