Infection ViralPhase 2NCT04354155
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
A Phase 2 study testing Enoxaparin Prefilled Syringe [Lovenox] in people with Infection Viral and Thromboses, Venous, run by Johns Hopkins All Children's Hospital at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Infection Viral, Thromboses, Venous, COVID-19
- What is being tested?
- Enoxaparin Prefilled Syringe [Lovenox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 16 sitesUnited States
- Study dates
- 2 Jun 2020to 4 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Birth to <18 years of age; AND
- Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
- Hospitalized, <72 hours post-admission; AND
- One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:
- Cough; OR
- Fever (oral temperature >100.4°F/38°C); OR
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- Chest pain; OR
- Shortness of breath; OR
- Myalgia; OR
- Acute unexplained loss of smell or taste; OR
- New/increased supplemental oxygen requirement; OR
- Acute respiratory failure requiring non-invasive or invasive ventilation; OR
- Encephalitis.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
- Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
- Platelet count <50,000/µL within the past 24 hours; OR
- Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
- Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
Show all 9Show fewer
- Fibrinogen level <75 mg/dL; OR
- Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31 mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR
- Parent or legally authorized representative unwilling to provide informed consent for patient participation.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Akron Children's Hospital
Akron, Ohio, 44308
Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Hospital and Children's Center
Baltimore, Maryland, 21287
Children's of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Lurie Children's Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Children's Medical Center of Dallas
Dallas, Texas, 75235
Children's Hospital of Michigan
Detroit, Michigan, 48201
Children's Hospital Los Angeles
Los Angeles, California, 90027
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Children's Hospital Pittsburgh
Pittsburgh, Pennsylvania, 15224
Hemostasis and Thrombosis Center UC Davis
Sacramento, California, 95817
Rady Children's Hospital
San Diego, California, 92123
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
- Conditions
- Infection Viral, Thromboses, Venous, COVID-19
- Being tested
- Enoxaparin Prefilled Syringe [Lovenox]
- Medical subject headings
- Virus Diseases, Venous Thrombosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Prefilled Syringe [Lovenox]Drug
Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
| Study group | Role | What they receive |
|---|---|---|
| Thromboprophylaxis | Experimental | Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL) Receives: Drug: Enoxaparin Prefilled Syringe [Lovenox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
The safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis will be measured by cumulative incidence (number of participants) of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following:
- fatal bleeding;
- clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period;
- retroperitoneal, pulmonary, or central nervous system bleeding;
- bleeding requiring surgical intervention in an operating suite;
- bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition);
- bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Measured: Day 30
Secondary outcomes (1)
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL
The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4-hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (<12 and those >12 years of age).
Measured: 4 hours post initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start2 Jun 2020
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Sochet, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354155
- Sponsor's protocol ID
- COVAC-TP
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2020
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sochet AA, Sellers AR, Betensky M, Morrison JM, Ashour D, Fierstein JL, Amankwah EK, Bruzek S, Ignjatovic V, Goldenberg NA; COVID-19 Anticoagulation in Children-Thromboprophylaxis Trial Investigators. Immunothrombosis and plasma fibrinolytic function for pediatric COVID-19: a secondary analysis from the COVAC-TP trial. Blood Vessel Thromb Hemost. 2024 Nov 26;2(1):100038. doi: 10.1016/j.bvth.2024.100038. eCollection 2025 Feb.
PubMed 40766870Sochet AA, Morrison JM, Jaffray J, Godiwala N, Wilson HP, Thornburg CD, Bhat RV, Zia A, Lawrence C, Kudchadkar SR, Hamblin F, Russell CJ, Streiff MB, Spyropoulos AC, Amankwah EK, Goldenberg NA; COVID-19 Anticoagulation in Children - Thromboprophylaxis (COVAC-TP) Trial Investigators. Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial. Pediatrics. 2022 Jul 1;150(1):e2022056726. doi: 10.1542/peds.2022-056726.
PubMed 35484817Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
PubMed 35244208Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
PubMed 33502773
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
- ClinicalTrials.gov ID
- NCT04354155
- Acronym / sponsor ID
- COVAC-TP
- Conditions
- Infection Viral, Thromboses, Venous, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboprophylaxis | Experimental | Drug: Enoxaparin Prefilled Syringe [Lovenox]Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 mg/kg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL) |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Birth to <18 years of age; AND
- Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND
- Hospitalized, <72 hours post-admission; AND
- One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as follows:
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Receiving therapeutic anticoagulation for treatment of a thromboembolic event diagnosed within the past 12 weeks; OR
- Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past 72 hours; OR
- Platelet count <50,000/µL within the past 24 hours; OR
- Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours; OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin Prefilled Syringe [Lovenox]Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL) | Drug | Thromboprophylaxis |
Primary outcome
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
Time frame: Day 30
The safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis will be measured by cumulative incidence (number of participants) of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1. fatal bleeding; 2. clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3. retroperitoneal, pulmonary, or central nervous system bleeding; 4. bleeding requiring surgical intervention in an operating suite; 5. bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6. bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
1 secondary outcome
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL
Time frame: 4 hours post initial dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40766870Sochet AA, Sellers AR, Betensky M, Morrison JM, Ashour D, Fierstein JL, Amankwah EK, Bruzek S, Ignjatovic V, Goldenberg NA; COVID-19 Anticoagulation in Children-Thromboprophylaxis Trial Investigators. Immunothrombosis and plasma fibrinolytic function for pediatric COVID-19: a secondary analysis from the COVAC-TP trial. Blood Vessel Thromb Hemost. 2024 Nov 26;2(1):100038. doi: 10.1016/j.bvth.2024.100038. eCollection 2025 Feb.
- Derived from this study: PubMed 35484817Sochet AA, Morrison JM, Jaffray J, Godiwala N, Wilson HP, Thornburg CD, Bhat RV, Zia A, Lawrence C, Kudchadkar SR, Hamblin F, Russell CJ, Streiff MB, Spyropoulos AC, Amankwah EK, Goldenberg NA; COVID-19 Anticoagulation in Children - Thromboprophylaxis (COVAC-TP) Trial Investigators. Enoxaparin Thromboprophylaxis in Children Hospitalized for COVID-19: A Phase 2 Trial. Pediatrics. 2022 Jul 1;150(1):e2022056726. doi: 10.1542/peds.2022-056726.
- Derived from this study: PubMed 35244208Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
- Derived from this study: PubMed 33502773Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Sochet, MD principal investigator
Johns Hopkins All Children's Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoxaparin Prefilled Syringe [Lovenox] in people with Infection Viral and Thromboses, Venous, run by Johns Hopkins All Children's Hospital at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354155, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.