Trial Outcomes & Findings for Thromboembolic Risk Screening in Patients With Cancer and COVID-19 (NCT NCT04616846)
NCT ID: NCT04616846
Last Updated: 2026-07-01
Results Overview
Deep venous thrombosis and/or pulmonary embolism.
COMPLETED
NA
88 participants
From Day 9 to Day 42
2026-07-01
Participant Flow
A total of 88 participants were registered in the database. Documented COVID-19 positivity was a requirement for analysis, which was met by 20 participants. Among these 20 eligible participants, only 12 underwent the specific diagnostic procedures required to detect thrombosis, while data for the remaining 8 participants are missing as the examinations could not be conducted. All baseline characteristics and final evaluations are therefore reported for this single analyzed pool.
COVID-19 positivity was an eligibility requirement for analysis. Out of all registered patients, only 20 were COVID-19 positive. Due to this extremely small sample size and a lack of statistical power, the prospective and retrospective cohorts were combined into a single analytical pool. Subgroup analyses were impossible. Additionally, only 12 of these 20 participants underwent the specific diagnostic procedures required for full evaluation.
Participant milestones
| Measure |
Enrolled Study Cohort
All registered participants monitored during the study period, including those screened for COVID-19 status.
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
Included
|
84
|
|
Overall Study
Tested Positive for COVID-19
|
20
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
76
|
Reasons for withdrawal
| Measure |
Enrolled Study Cohort
All registered participants monitored during the study period, including those screened for COVID-19 status.
|
|---|---|
|
Overall Study
Tested Negative for COVID-19
|
68
|
|
Overall Study
Specific diagnostic procedures not conducted
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Group
n=84 Participants
All participants enrolled in the study to evaluate the occurrence of venous thromboembolism during COVID 19 infection.
|
|---|---|
|
Age, Continuous
|
61.73 years
STANDARD_DEVIATION 11.92 • n=84 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=84 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=84 Participants
|
|
COVID-19 Vaccination Status
Yes
|
17 Participants
n=60 Participants • The vaccination status was available for 60 out of 84 participants. For the remaining 24 participants, vaccination history could not be reliably retrieved from medical records or patient interviews at the time of enrollment. Therefore, the analysis for this specific baseline characteristic is limited to the sub-population with documented status.
|
|
COVID-19 Vaccination Status
No
|
43 Participants
n=60 Participants • The vaccination status was available for 60 out of 84 participants. For the remaining 24 participants, vaccination history could not be reliably retrieved from medical records or patient interviews at the time of enrollment. Therefore, the analysis for this specific baseline characteristic is limited to the sub-population with documented status.
|
|
COVID-19 Status
Positive
|
20 Participants
n=84 Participants
|
|
COVID-19 Status
Negative
|
64 Participants
n=84 Participants
|
PRIMARY outcome
Timeframe: From Day 9 to Day 42Population: Out of the 20 COVID-19 positive participants, only 12 underwent specific diagnostic procedures to detect thrombosis. Data for the remaining 8 participants are missing as the exams were not conducted.
Deep venous thrombosis and/or pulmonary embolism.
Outcome measures
| Measure |
Single Group
n=12 Participants
All participants enrolled in the study to evaluate the occurrence of venous thromboembolism during COVID 19 infection.
|
COVID-19 Positive
Participants with a confirmed SARS-CoV-2 infection. Positivity was defined by a positive RT-PCR result from a nasopharyngeal swab at the time of inclusion.
|
|---|---|---|
|
Rate of Venous Thromboembolism
Presence of Thrombosis
|
3 Participants
|
—
|
|
Rate of Venous Thromboembolism
Absence of Thrombosis
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 23Common toxicity criteria from the NCI CTCAE V5.0
Outcome measures
| Measure |
Single Group
n=35 Participants
All participants enrolled in the study to evaluate the occurrence of venous thromboembolism during COVID 19 infection.
|
COVID-19 Positive
n=12 Participants
Participants with a confirmed SARS-CoV-2 infection. Positivity was defined by a positive RT-PCR result from a nasopharyngeal swab at the time of inclusion.
|
|---|---|---|
|
Rate of Symptomatic Venous Thromboembolism Between the COVID-19 Negative and COVID-19 Positive Patients
Presence of Thrombosis
|
3 Participants
|
3 Participants
|
|
Rate of Symptomatic Venous Thromboembolism Between the COVID-19 Negative and COVID-19 Positive Patients
Absence of Thrombosis
|
32 Participants
|
9 Participants
|
Adverse Events
Single Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Centre Antoine Lacassagne
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60