Trial Outcomes & Findings for Nebulized Heparin for COVID19-associated Acute Respiratory Failure (NCT NCT04842292)

NCT ID: NCT04842292

Last Updated: 2022-10-18

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
• Results posted on: 2022-10-18

Participant Flow

Two participants were enrolled. To protect privacy, data will not be presented for each arm.

Participant milestones

Measure	Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nebulized Heparin for COVID19-associated Acute Respiratory Failure

Baseline characteristics by cohort

Measure	Participants n=2 Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data for the two arms will be combined.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first

Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.

Outcome measures

Measure	Participants n=2 Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Mean PaO2/FiO2 Ratio	NA units on a scale Standard Deviation NA Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.

SECONDARY outcome

Timeframe: Up to discharge or 3 months following enrollment, whichever occurs first

Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.

Outcome measures

Measure	Participants n=2 Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Clinically Significant Bleeding	NA units on a scale Standard Deviation NA Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.

SECONDARY outcome

Timeframe: Up to discharge or 3 months following enrollment, whichever occurs first

Population: Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.

Outcome measures

Measure	Participants n=2 Participants Two participants were enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Incidence of Venous Thromboembolism	NA Incidence Due to the possibility that individual participant data could be identified since there were only 2 participants, data cannot be presented without risking participant privacy.

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brittany Bissell

University of Kentucky

Phone: 8593239308

Email: bdbi223@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place