Trial · NCT04530604

Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)

NCT04530604, Phase 1, Completed, Gregory Yanik; results first posted 2023-05-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS). Trials, record NCT04530604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04530604

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)
NCT number: NCT04530604
Status: Completed
Phases: Phase 1
Enrollment: 13 participants, actual
Lead sponsor: Gregory Yanik
Conditions: COVID, Sars-CoV2, COVID-19, Acute Respiratory Distress Syndrome
Interventions: Defibrotide
First posted: 2020-08-28
Last updated: 2023-05-09
Results first posted: 2023-05-09

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Major Hemorrhagic Complications Within 14 Days of Initiation of Treatment	14 days	Major hemorrhagic complications will be based on the International Society on Thrombosis and Haemostasis Bleeding scale. 1. Fatal Bleeding, and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, and/or 3. Bleeding associated with a decline in hemoglobin level of \> 2.0 g/dl, leading to transfusion of two or more units of whole blood or red cells. 4. In addition, symptomatic alveolar hemorrhage, macroscopic hematuria, uncontrolled menorrhagia or epistaxis or bleeding from any wound site would also be considered a major hemorrhagic event.
Secondary	Overall Survival	28 days	Number of patients who are alive at Day 28 after starting treatment.
Secondary	Overall Survival	14 days	Number of patients who are alive at Day 14 after starting treatment.
Secondary	Ventilator-free Survival	14 days	Day 14 ventilator-free survival will be summarized by the number of patients who are both alive and not using a ventilator at Day 14 after starting treatment.
Secondary	Number of Ventilator Free Days Within 14 Days of Study Entry	14 days
Secondary	The Time to Improvement in Oxygenation	up to 14 days	Improvement in oxygenation defined as an increase in ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) of 50 (or greater) compared to the nadir of PaO2/FiO2.
Secondary	Mean Change in the WHO COVID-19 Ordinal Scale During Therapy	up to 14 days	Ordinal scale: 1. = Ambulatory, no limitation of activities; 2. = Ambulatory, Activity LImited; 3. = Hospitalized, no oxygen therapy; 4. = Oxygen by mask or nasal cannula; 5. = Non-invasive ventilation or high-flow oxygen (O2); 6. = Intubation/mechanical ventilation; 7. = Intubation/Mechanical ventilation plus one of the following: Pressors, Extracorporeal membrane oxygenation (ECMO) or Dialysis; 8. = Decased/Death Key: For change in ordinal score, negative values represent a decline in WHO score from baseline to day 14 (improvement of condition); positive values represent an increase (worsening of condition).

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Major Hemorrhagic Complications Within 14 Days of Initiation of Treatment	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	14 days		participants	NUMBER
SECONDARY	Ventilator-free Survival	14 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Ventilator Free Days Within 14 Days of Study Entry	14 days		days	MEDIAN
SECONDARY	The Time to Improvement in Oxygenation	up to 14 days	4 participants had improvement by day 14	days	MEAN
SECONDARY	Mean Change in the WHO COVID-19 Ordinal Scale During Therapy	up to 14 days		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Major Hemorrhagic Complications Within 14 Days of Initiation of Treatment	Defibrotide	0		Participants
Overall Survival	Defibrotide	10		Participants
Overall Survival	Defibrotide	11		participants
Ventilator-free Survival	Defibrotide	5		Participants
Number of Ventilator Free Days Within 14 Days of Study Entry	Defibrotide	0	Full Range 0 to 14	days
The Time to Improvement in Oxygenation	Defibrotide	4	Full Range 2 to 6	days
Mean Change in the WHO COVID-19 Ordinal Scale During Therapy	Defibrotide	-1	Full Range -5 to 1	score on a scale

Source ClinicalTrials.gov

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Defibrotide	12
Overall Study	Completed Dosing	Defibrotide	10
Overall Study	COMPLETED	Defibrotide	12
Overall Study	NOT COMPLETED	Defibrotide	0

Source ClinicalTrials.gov

Adverse events23

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
other	Anemia	Blood and lymphatic system disorders	Defibrotide	1	12
other	Leukocytosis	Blood and lymphatic system disorders	Defibrotide	3	12
other	Thrombocytosis	Cardiac disorders	Defibrotide	3	12
other	Pulmonary Infections (bacterial)	Infections and infestations	Defibrotide	4	12
other	Hypernatremia	Investigations	Defibrotide	3	12
other	Hyperkalemia	Investigations	Defibrotide	1	12
other	Hypercalcemia	Investigations	Defibrotide	1	12
other	Increased ALT	Investigations	Defibrotide	3	12
other	Increased AST	Investigations	Defibrotide	3	12
other	Uremia	Investigations	Defibrotide	3	12

1 to 10 of 23Source ClinicalTrials.gov

See all 23 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Defibrotide	3	12
Total, other adverse events	Defibrotide	9	12
Total, serious adverse events	Defibrotide	6	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35413279	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04530604

GET https://conductscience.org/api/trials/v1/NCT04530604/events?page=2

API reference For AI assistants