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TERMINATEDPHASE2

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

A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19

NCT04458298•Ashvattha Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stage I:
•Body mass index (BMI) less than or equal to (\<=) 35 kilogram per meter square (kg/m\^2)
•Positive laboratory test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or respiratory infection with recent exposure to a person with laboratory-proven SARS-CoV-2
•Patient has an ordinal scale score between 5 and 7, inclusive, using the WHO 7OS
•Hypoxemia defined by saturation of peripheral oxygen (SpO2) of less than (\<) 95 percent (%) on room air or Acute respiratory distress syndrome (ARDS)
•Occurrence of at least two of the following criteria: fever greater than (\>) 38.0 degree celsius, tachycardia \>90 beats/minute, tachypnea \>20 breaths/minute, leucocytosis \>12\*109 per liter (/L) or leucopoenia \<4 \*10\^9/L
•Enrollment must occur within 72 hours from the initiation of mechanical ventilation or high-flow oxygen
•A signed informed consent form (ICF) from the patient or the patient's legally authorized representative must be available (telephone consent is acceptable)
•Female patients may not be pregnant, lactating, or breastfeeding
•Female patients of childbearing potential must have negative result for pregnancy test at screening
+15 more criteria

Exclusion Criteria

•Stage I:
•Not expected to survive for more than 24 hours
•Underlying clinical condition where, in the opinion of the investigator, it would be extremely unlikely that the patient would come off ventilation (eg, motor neuron disease, Duchenne muscular dystrophy, or rapidly progressive interstitial pulmonary fibrosis)
•Severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure used solely for sleep-disordered breathing
•Congestive heart failure, defined as New York Heart Association Class IV
•Acute left ventricular failure or myocardial infarction
•Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
•Receiving renal dialysis therapy for chronic renal failure
•Moderate to severe liver failure (Childs-Pugh Score \>12)
•Presence of any active malignancy (other than nonmelanoma skin cancer) that required treatment within the last 2 years
+27 more criteria

Locations (8)

Research Site

Loma Linda, California, United States

Research site

Fort Lauderdale, Florida, United States

Research site

Jacksonville, Florida, United States

Research Site

Atlanta, Georgia, United States

Research site

Baltimore, Maryland, United States

Research Site

Sioux Falls, South Dakota, United States

Research Site

Amarillo, Texas, United States

Research Site

Houston, Texas, United States

Key Dates

Start Date

August 11, 2020

Primary Completion Date

August 12, 2022

Completion Date

August 12, 2022

Last Updated

February 13, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

OP-101

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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