Covid19Phase 4APOLLONCT04746339
Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19
A Phase 4 study testing Apixaban 2.5 MG in people with Covid19 and Thrombosis, run by Brazilian Clinical Research Institute at 4 sites in Brazil.
Trial summary
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Thrombosis
- What is being tested?
- Apixaban 2.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 411 participants
- Where
- 4 sitesBrazil
- Study dates
- 4 Mar 2021to 30 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with symptomatic laboratory-proven diagnosis of COVID-19 (any exam that shows acute infection as positive PCR or IgM in a context of acute symptoms ≤ 10 days) AND
- Negative pregnancy test for women in child bearing period AND
- D-dimer level ≥ 2x ULN or
- C-reactive protein (CRP) ≥ 10 mg/L or
- At least two of the following risk factors:
- d-dimer level ≥ULN
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- CRP ≥ULN
- age ≥65,
- diabetes,
- chronic kidney disease stage 3
- cardiopulmonary disease (for example, peripheral arterial disease, coronary artery disease, heart failure, chronic obstructive pulmonary disease),
- history of PE/DVT,
- nursing home/SNF resident or severely restricted mobility
- Body mass index ≥30 kg/m2.
Who cannot join
- Age < 18 years-old
- Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
- Platelets < 50,000 /mm3
- Use of acetylsalicylic acid > 100 mg per day
- Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)
- Chronic use of NSAIDs
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- Hypersensitivity to apixaban
- Creatinine clearance < 30 ml/min
- Pregnancy or breastfeeding
- Patients contraindicated to anticoagulation (active bleeding, recent major surgery, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator)
- A history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (AV) malformation, or aneurysm
- Use of strong inhibitors of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) (e.g. protease inhibitors, ketoconazole, Itraconazole) and/or use of P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort)
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo
Hospital Israelita Albert Einstein
São Paulo, São Paulo
Hospital Santa Paula
São Paulo
About this study
Official title: Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
Read the detailed description
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for 30 days.
Primary Objective: To evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (DAOH) through 30 days in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis.
- Conditions
- Covid19, Thrombosis
- Being tested
- Apixaban 2.5 MG, Placebo
- Keywords
- SARS-CoV2, Anticoagulation, Apixaban
- Medical subject headings
- COVID-19, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 MGDrug
Apixaban 2.5mg twice daily for 30 days
PlaceboDrug
placebo twice daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Apixaban Group | Active comparator | Not described Receives: Drug: Apixaban 2.5 MG |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days alive and out of hospital or emergency department
Number of days alive and out of hospital or emergency department through 30 days.
Measured: In 30 days
Secondary outcomes (6)
Hospitalization due to bleeding
Measured: In 30 days
Hospitalizations for cardiopulmonary causes
Measured: In 30 days
All-cause hospitalization
Measured: In 30 days
All-cause death
Measured: In 30 days
Days free of venous thromboembolism
Venous thromboembolism (VTE) include deep venous thrombosis and pulmonary embolism.
Measured: In 30 days
Major cardiovascular events (MACE)
Major cardiovascular events (MACE) includes cardiovascular death, myocardial infarction (MI) and stroke.
Measured: In 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start4 Mar 2021
- Primary completion13 May 2022
- Study completion30 May 2022
Why it stopped: Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein, Hospital do Coracao, Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Beneficência Portuguesa de São Paulo, Brazilian Research In Intensive Care Network
- Responsible party
- Sponsor
- Investigators
- Renato D. Lopes, MD, PhD, Study chair, BCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746339
- Sponsor's protocol ID
- 004/2020
- Acronym
- APOLLO
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2021
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.
Publications
Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
PubMed 37591523
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for PrOphyLaxis of thromboemboLic Outcomes in COVID-19 - the Apollo Trial
- ClinicalTrials.gov ID
- NCT04746339
- Acronym / sponsor ID
- APOLLO / 004/2020
- Conditions
- Covid19, Thrombosis
- Keywords
- SARS-CoV2, Anticoagulation, Apixaban
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Israelita Albert Einstein, Hospital do Coracao, Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Beneficência Portuguesa de São Paulo, Brazilian Research In Intensive Care Network
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
Detailed description
Randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic COVID-19 infection and risk factors for thrombosis.
Randomization 1:1 - Group 1 will receive Apixaban 2.5mg twice daily vs. matching placebo (Group 2) for 30 days.
Primary Objective: To evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (DAOH) through 30 days in outpatients with symptomatic SARS-CoV2 infection and risk factors for thrombosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban Group | Active comparator | Drug: Apixaban 2.5 MG |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Outpatients with symptomatic laboratory-proven diagnosis of COVID-19 (any exam that shows acute infection as positive PCR or IgM in a context of acute symptoms ≤ 10 days) AND
- Negative pregnancy test for women in child bearing period AND
- D-dimer level ≥ 2x ULN or
- C-reactive protein (CRP) ≥ 10 mg/L or
- At least two of the following risk factors:
Key exclusion criteria (12 listed)
- Age < 18 years-old
- Patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis)
- Platelets < 50,000 /mm3
- Use of acetylsalicylic acid > 100 mg per day
- Use of P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor)
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 |
|---|---|---|
| Apixaban 2.5 MGApixaban 2.5mg twice daily for 30 days | Drug | Apixaban Group |
| Placeboplacebo twice daily for 30 days | Drug | Placebo Group |
Primary outcome
Number of days alive and out of hospital or emergency department
Time frame: In 30 days
Number of days alive and out of hospital or emergency department through 30 days.
6 secondary outcomes
Hospitalization due to bleeding
Time frame: In 30 days
Hospitalizations for cardiopulmonary causes
Time frame: In 30 days
All-cause hospitalization
Time frame: In 30 days
All-cause death
Time frame: In 30 days
Days free of venous thromboembolism
Time frame: In 30 days
Major cardiovascular events (MACE)
Time frame: In 30 days
Results and safety
The study was stopped early (reason given: Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 37591523Santos BC, Flumignan RL, Civile VT, Atallah AN, Nakano LC. Prophylactic anticoagulants for non-hospitalised people with COVID-19. Cochrane Database Syst Rev. 2023 Aug 16;8(8):CD015102. doi: 10.1002/14651858.CD015102.pub2.
- Individual participant dataSharing planned: Yes. All data provided during study is anonymized to respect the privacy of patients who have participated in the trial in line with applicable regulations.
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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.
Renato D. Lopes, MD, PhD study chair
BCRI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban 2.5 MG in people with Covid19 and Thrombosis, run by Brazilian Clinical Research Institute at 4 sites in Brazil.
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 14 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the decrease in COVID cases and in the recruitment rate, and DSMB orientation.). Results are not available in the source record.
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?
Number of days alive and out of hospital or emergency department (time frame: In 30 days). 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 NCT04746339, which also lists 1 linked publication.
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 25 Aug 2022.