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A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients

NCT04458298 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-02-13

No results posted yet for this 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.

Conditions

Interventions

DRUG

OP-101

OP-101 infusion will be administered intravenously.

DRUG

Placebo

Matching placebo infusion will be administered intravenously.

Sponsors & Collaborators

  • Ashvattha Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2022-08-12
Completion
2022-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458298 on ClinicalTrials.gov