Trial · NCT04505592
Tenecteplase in Patients With COVID-19
NCT04505592, Phase 2, Completed, Hooman Poor; results first posted 2023-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tenecteplase in Patients With COVID-19. Trials, record NCT04505592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04505592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tenecteplase in Patients With COVID-19
- NCT number
- NCT04505592
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Hooman Poor
- Conditions
- COVID-19, Respiratory Failure, ARDS
- Interventions
- Tenecteplase, Placebo
- First posted
- 2020-08-10
- Last updated
- 2023-04-06
- Results first posted
- 2023-04-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Free of Respiratory Failure | 28 Days | The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days |
| Primary | Number of Participants With Occurrences of Bleeding | 28 days | Safety as assessed by number of participants with occurrences of intracranial bleeding or major bleeding |
| Secondary | Number of Participants With In-hospital Deaths at 14 Days | 14 days | Number of patients who expired in the hospital within the first 14 days of their participation in the study |
| Secondary | Number of Participants With Death at 28 Days | 28 days | Number of participants who expired by 28 days/end of study |
| Secondary | Number of Ventilator-free Days | 28 days | Number of ventilator-free days in 28 days period |
| Secondary | Number of Respiratory Failure-free Days | 28 days | Respiratory failure-free defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation. Number of respiratory failure-free days in 28 days period. |
| Secondary | Number of Vasopressor-free Days | 28 days | Number of vasopressor-free days over 28 days period |
| Secondary | Number of Vasopressor Doses at 24 Hours | 24 hours and 72 hours | |
| Secondary | P/F Ratio | 24 hours and 72 hours | The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). Ratio of arterial pO2 over fraction of inspired oxygen that the person is receiving. Normal P/F Ratio is ≥ 400. 300 to 200 is considered mild ARDS 200 to 100 is considered moderate ARDS Anything below 100 is considered severe ARDS. |
| Secondary | Number of ICU-free Days | 28 days | Number of days the patient spent outside the ICU |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Free of Respiratory Failure | 28 Days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Occurrences of Bleeding | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With In-hospital Deaths at 14 Days | 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Death at 28 Days | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Ventilator-free Days | 28 days | days | MEDIAN | |
| SECONDARY | Number of Respiratory Failure-free Days | 28 days | days | MEDIAN | |
| SECONDARY | Number of Vasopressor-free Days | 28 days | days | MEDIAN | |
| SECONDARY | Number of Vasopressor Doses at 24 Hours | 24 hours and 72 hours | doses | NUMBER | |
| SECONDARY | P/F Ratio | 24 hours and 72 hours | Ratio | MEDIAN | |
| SECONDARY | Number of ICU-free Days | 28 days | days | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Free of Respiratory Failure | Tenecteplase | 5 | Participants | ||
| Number of Participants Free of Respiratory Failure | Placebo | 2 | Participants | ||
| Number of Participants With Occurrences of Bleeding | Tenecteplase | 2 | Participants | ||
| Number of Participants With Occurrences of Bleeding | Placebo | 1 | Participants | ||
| Number of Participants With In-hospital Deaths at 14 Days | Tenecteplase | 2 | Participants | ||
| Number of Participants With In-hospital Deaths at 14 Days | Placebo | 1 | Participants | ||
| Number of Participants With Death at 28 Days | Tenecteplase | 2 | Participants | ||
| Number of Participants With Death at 28 Days | Placebo | 1 | Participants | ||
| Number of Ventilator-free Days | Tenecteplase | 18 | Inter-Quartile Range 3 to 28 | days | |
| Number of Ventilator-free Days | Placebo | 19 | Inter-Quartile Range 9 to 28 | days |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tenecteplase | 8 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Tenecteplase | 6 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Tenecteplase | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Renal failure | Renal and urinary disorders | Tenecteplase | 1 | 8 | |
| other | Renal failure | Renal and urinary disorders | Placebo | 1 | 5 | |
| other | Decreased hemoglobin | Blood and lymphatic system disorders | Tenecteplase | 1 | 8 | |
| other | Decreased hemoglobin | Blood and lymphatic system disorders | Placebo | 0 | 5 | |
| other | Mild oral bleeding | Blood and lymphatic system disorders | Tenecteplase | 1 | 8 | |
| other | Mild oral bleeding | Blood and lymphatic system disorders | Placebo | 0 | 5 | |
| other | Acute kidney injury | Renal and urinary disorders | Tenecteplase | 1 | 8 | |
| other | Acute kidney injury | Renal and urinary disorders | Placebo | 1 | 5 | |
| other | Bleeding from mouth and wrist | Blood and lymphatic system disorders | Tenecteplase | 1 | 8 | |
| other | Bleeding from mouth and wrist | Blood and lymphatic system disorders | Placebo | 0 | 5 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenecteplase | 2 | 8 |
| Total, all-cause mortality | Placebo | 1 | 5 |
| Total, other adverse events | Tenecteplase | 3 | 8 |
| Total, other adverse events | Placebo | 2 | 5 |
| Total, serious adverse events | Tenecteplase | 4 | 8 |
| Total, serious adverse events | Placebo | 4 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tenecteplase vs Placebo: Number of Participants With In-hospital Deaths at 14 Days | Trial comparisons |
| Tenecteplase vs Placebo: Number of Participants Free of Respiratory Failure | Trial comparisons |
| Tenecteplase vs Placebo: Number of Participants With New-onset Renal Failure | Trial comparisons |
| Tenecteplase vs Placebo: Number of Participants With Death at 28 Days | Trial comparisons |
| Tenecteplase vs Placebo: Number of Participants With Occurrences of Bleeding | Trial comparisons |
| Tenecteplase vs Placebo: Number of Participants With Need for Renal Replacement Therapy | Trial comparisons |
| Tenecteplase vs Placebo: deaths from any cause | Trial comparisons |
| Tenecteplase vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04505592
GET https://conductscience.org/api/trials/v1/NCT04505592/results?page=2