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rhDNase IWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2047 Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.71
drug2046 Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.71
drug2045 Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.71

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Phase I Pilot Study Investigating the Safety and Tolerability of Inhaled rhDNase1 and Its Impact on Neutrophil Extracellular Traps (NETs) in Non-Ventilated COVID-19 Infected Patients

This is a pilot study to investigate the safety and tolerability of rhDNase1 and its impact on neutrophil extracellular traps (NETs) in COVID-19 infected patients

NCT04409925 COVID-19 Infection Drug: rhDNase I

Primary Outcomes

Measure: Safety of inhaled rhDNase1 in non-ventilated COVID-19 patients by reporting of adverse events: rate of all adverse events, rate of serious adverse events, rate of grade 3/4/5 adverse events, drug-related adverse events.

Time: 9 months

Secondary Outcomes

Description: Time to first study participant enrolment is defined as the time elapsed between the study opening date and the first patient enrolment date.

Measure: Time to first study participant enrolment

Time: Up to 2 weeks

Description: Enrolment rate is defined as the number of patients enrolled per week following the start of the study.

Measure: Enrolment rate

Time: Up to 9 months

Description: Eligible patient consent rate is defined as the number of patients meeting eligibility through inclusion and exclusion criteria that are consented and enrolled into the study.

Measure: Eligible patient consent rate

Time: Up to 9 months

Description: The percentage of doses missed compared to completed, including reasons for missed doses, per patient.

Measure: Completeness of drug delivery

Time: Up to 9 months

Description: The percentage of tests or procedures missed compared to completed, per patient.

Measure: Completeness of study-specific tests or procedures

Time: Up to 9 months

Description: The percentage of missing data compared to completed data, per patient.

Measure: Completeness of data collection

Time: Up to 9 months

Description: Extent of hypoxia rate is defined as the number of patients requiring supplemental oxygen, categorized by type of oxygen requirement.

Measure: Hypoxia rate

Time: Up to 9 months

Description: The type of oxygen in FiO2 requirements needed by each patient in the study, if applicable.

Measure: Supplemental oxygen requirement type

Time: Up to 9 months

Description: Number of patients progressing to requiring intubation and mechanical ventilation.

Measure: Progression to mechanical ventilation rate

Time: Up to 9 months

Description: Duration in days, for patients requiring intubation and mechanical ventilation, if applicable.

Measure: Duration of mechanical ventilation

Time: Up to 9 months

Description: Number of patients who show progression on imaging suggestive of ARDS such as bilateral lung involvement, as reviewed by study's thoracic radiologist.

Measure: Radiological progression

Time: Up to 9 months

Description: Number of patients with renal dysfunction, classified by stage (1, 2 or 3).

Measure: Renal dysfunction rate

Time: Up to 9 months

Description: Extent of change in creatinine from baseline.

Measure: Renal dysfunction extent

Time: Up to 9 months

Description: Time to hospital discharge of in-hospital mortality is defined as the time elapsed between enrolment into the study (at admission), and endpoint (discharge or in-hospital mortality).

Measure: Time to hospital discharge or in-hospital mortality

Time: Up to 9 months

Description: Number of health care workers in direct contact with study participants and developing a COVID-19 infection.

Measure: Overall safety of health care workers and study personnel

Time: Up to 9 months

Description: Number of times per day a health care worker enters each study participant's room.

Measure: Daily safety of health care workers and study

Time: Up to 9 months

Other Outcomes

Measure: Exploratory: NET quantification in blood and sputum, correlated to COVID-19 disease severity and complications (hypoxia, radiological progression, renal dysfunction, and time to hospital discharge or in-hospital mortality)

Time: 9 months

Measure: Exploratory: Blood clotting and fibrinolysis assays, correlated to COVID-19 disease severity and complications

Time: 9 months

Measure: Exploratory: Cytokine profile alterations in blood and sputum, correlated to COVID-19 disease severity and complications

Time: 9 months

Measure: Exploratory: Neutrophil RNA sequencing in blood and sputum, correlated to COVID-19 disease severity and complications

Time: 9 months

No related HPO nodes (Using clinical trials)