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Antioxidant

OP-101 for COVID-19 (PRANA Trial)

Phase 2
Waitlist Available
Research Sponsored by Orpheris, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 60
Awards & highlights

PRANA Trial Summary

This trial is looking at the safety and effectiveness of a new drug, OP-101, for treating people with severe COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus

PRANA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage I: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
Stage II: Percentage of Participants Who Were Alive (i.e., not died due to any reason) at Day 29
Secondary outcome measures
Stage I: Change from Baseline in the World Health Organization (WHO)-7 Point Ordinal Scale
Stage I: Incidence of Drug-related Serious Adverse Events (SAEs)
Stage I: Number of Days in Intensive Care Unit (ICU)
+18 more

Side effects data

From 2020 Phase 1 trial • 8 Patients • NCT04321980
25%
Injection site pain
25%
Injection site pallor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: 4 mg/kg
Cohort 2: 8 mg/kg

PRANA Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Stage II: Cohort E: OP-101 8 mg/kgExperimental Treatment1 Intervention
Participants will receive a single IV infusion of OP-101 8 mg/kg on Days 1 and 4.
Group II: Stage I: Cohort C: OP-101 8 mg/kgExperimental Treatment1 Intervention
Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1.
Group III: Stage I: Cohort B: OP-101 4 mg/kgExperimental Treatment1 Intervention
Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1.
Group IV: Stage I: Cohort A: OP-101 2 mg/kgExperimental Treatment1 Intervention
Participants will receive a single intravenous (IV) infusion of OP-101 2 milligram per kilogram (mg/kg) on Day 1.
Group V: Stage I: Cohort D: PlaceboPlacebo Group1 Intervention
Participants will receive a single IV infusion of matching placebo on Day 1.
Group VI: Stage II: Cohort F: PlaceboPlacebo Group1 Intervention
Participants will receive a single IV infusion of matching placebo on Days 1 and 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OP-101
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Orpheris, Inc.Lead Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
Ashvattha Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients
2020. "A Study to Evaluate OP-101 (Dendrimer N-acetyl-cysteine) in Severe Coronavirus Disease 2019 (COVID-19) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04458298.
~6 spots leftby Apr 2025
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