CompletedNCT04655586ASPENUpdated Feb 21, 2023Results posted

Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19

A Phase 2/3 interventional study of rNAPc2 and Heparin in Covid19, sponsored by ARCA Biopharma, Inc.. Completed at 24 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by ARCA Biopharma, Inc. · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 160
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.

Read the detailed description

Sequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2, a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels. Study participants and Clinical Endpoint Committee (CEC) members assessing the clinical endpoints will be blinded to treatment assignment. The protocol comprises sequential Phase 2b and Phase 3 studies. Analysis of Phase 2b data could lead to study discontinuation, adjustment of eligibility criteria or sample size, and will inform the rNAPc2 dose level to be studied in Phase 3.

Conditions studied

Covid19

Browse trials for

COVID-19 7,640

Keywords

D-dimer
Thromboprophylaxis
Anti-coagulant
Thrombotic Events
Coagulation
Inflammation
Heparin

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 160 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ARCA Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥ 18 years and ≤ 90 years at the Screening assessment
Weight ≥ 50 kg at randomization
Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care
Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid samples by PCR or validated other test of ongoing infection (not an antibody test for prior exposure), within seven (7) days of hospitalization or screening assessment
D-dimer level > upper limit of normal at screening
Provided electronic or written informed consent, either personally or through a legally authorized representative (LAR)
Must agree not to participate in a concurrent interventional study involving anticoagulation or anti-platelet therapy
Female patients of reproductive or child-bearing potential must be willing to use an effective method of contraception for the duration of the study, and male patients must be willing to use an effective method of contraception to avoid partner pregnancy and abstain from sperm donation for at least 90 days after last dose

Exclusion criteria

Exclusion Criteria:

High bleeding risk, e.g. major surgery within prior 1 month, history of a major bleed while receiving anticoagulation, recent hemorrhagic stroke, current or planned (during current hospitalization) dual anti-platelet therapy, platelet count \<25,000/uL, current therapeutic anticoagulation for a medical indication other than COVID-19, e.g. atrial fibrillation, known thrombosis, hereditary or acquired coagulopathy treated with therapeutic anticoagulation. Patients receiving prophylactic anticoagulation are eligible if they are willing to discontinue current anticoagulation.
Sustained systolic blood pressure \< 90 mmHg considered to be clinically significant
Persistent eGFR \<20 ml/min/1.73m2
Known severe liver disease (e.g. bilirubin >3.5 mg/dL (60 umol/L))
Life expectancy estimated to be \< 72 hours based on current clinical condition
Anticipated hospital discharge or transfer within 5 days based on current clinical condition
Known anti-phospholipid syndrome
Unable to receive heparin, e.g. history of heparin-induced thrombocytopenia and thrombosis (HITT)
Participation in any interventional clinical study with an investigational product within seven (7) days of the Screening assessment or within 5 half-lives of the investigational agent, whichever is longer

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 160 participants (actual)

Study arms

Experimental
rNAPc2 Higher Dose
loading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5
Drug: rNAPc2
Experimental
rNAPc2 Lower Dose
loading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5
Drug: rNAPc2
Active comparator
Heparin
heparin at either prophylactic or therapeutic doses per Standard of Care at Institution
Drug: Heparin

Interventions

DrugrNAPc2
two dose levels of rNAPc2
Also known as: AB201, Recombinant Nematode Anticoagulant Protein c2
DrugHeparin
standard of care heparin per institution (therapeutic or prophylactic regimen)

What researchers measure

Primary outcomes

Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.
Time frame: 8 days

Secondary outcomes

Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 2/3 or early discharge - D-Dimer level at baseline)/D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory.
Time frame: 2 days and 3 days
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b)
Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized.
Time frame: 8 days
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b)
Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized.
Time frame: 30 days
Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.
Time frame: 8 days
Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.
Time frame: 8 days
Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.
Time frame: 8 days
Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.
Time frame: 8 days

Results

Posted Feb 21, 2023

Participant flow

Eligible participants were men and women (18 to 90 years) with a confirmed COVID-19 diagnosis requiring inpatient medical care and an elevated D-dimer level at screening. Enrollment began DEC2020 with the last assessment in MAR2022. 160 participants were enrolled at 15 clinical sites in Argentina, Brazil, and the United States. Originally designed as a sequential Phase 2B/3, the Ph2B top line results dictated substantial design changes for progression to Ph3 and the study was concluded at Ph2.

Participant flow — Overall Study
Milestone	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Started	40	40	80
Completed	38	34	75
Not completed	2	6	5
Withdrew: Physician decision	1	3	4
Withdrew: Withdrawal by subject	1	3	1

Outcome measures

PrimaryProportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)

Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.

Time frame:: 8 days
Reported as:: Mean · Percent change

Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)
Percent change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)	137 ± 422.3	41.4 ± 194.6	34.7 ± 133.2

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 0.4715 (All rNAPc2 vs. Heparin)

SecondaryProportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b)

Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 2/3 or early discharge - D-Dimer level at baseline)/D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory.

Time frame:: 2 days and 3 days
Reported as:: Mean · percentage change

Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b)
percentage change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Day 2 (24h post D1 dose)	23.9 ± 213.9	-0.1 ± 40.3	43.5 ± 317.5
Day 3 (48h post D1 dose)	65.8 ± 264.5	-2.3 ± 68.5	21.5 ± 147.3

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 0.1883

SecondaryNumber of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b)

Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized.

Time frame:: 8 days
Reported as:: Count of participants · Participants

Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b)
Participants	rNAPc2 Lower Dose	Heparin
ISTH Major or Non-Major Clinically Relevant	0	1
Subjects with any ISTH if Major	1	1
TIMI Major	0	1
TIMI Minor	0	0
TIMI Medical attention	0	0
TIMI Minimal	1	0

SecondaryNumber of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b)

Time frame:: 30 days
Reported as:: Count of participants · Participants

Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b)
Participants	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
ISTH Major or Non-Major Clinically Relevant	1	1	1
ISTH Major	0	1	1
ISTH Non-major Clinically Relevant	1	0	0
ISTH Not Clinically Relevant	2	1	0
Subjects With Any ISTH if Major	3	2	1
TIMI Major	0	0	1
TIMI Minor	0	1	0
TIMI medical attention	1	0	0
TIMI Minimal	2	1	0

SecondaryChange in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)

Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.

Time frame:: 8 days
Reported as:: Mean · percent change

Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)
percent change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)	-26.1 ± 203.9	270.9 ± 1556.8	12.8 ± 226.3

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 1.0

SecondaryChange in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)

Time frame:: 8 days
Reported as:: Mean · percentage change

Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)
percentage change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)	317.4 ± 821.7	768.1 ± 1798.3	8.4 ± 113.8

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 0.0254

SecondaryChange in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)

Time frame:: 8 days
Reported as:: Mean · percentage change

Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)
percentage change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)	-21.2 ± 56.3	-1.8 ± 89.2	23.3 ± 103.6

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 0.0535

SecondaryChange in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)

Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline.

Time frame:: 8 days
Reported as:: Mean · percentage change

Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)
percentage change	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)	-24.04 ± 51.84	-274.3 ± 1562.57	62.99 ± 479.75

Statistical analysis

rNAPc2 Lower Dose vs rNAPc2 Higher Dose vs Heparin · Wilcoxon Rank Sum · p = 0.8300

Adverse events

Collected over All AEs were collected from the time of randomization until the participant completed Day 30 or final contact, whichever was longer. All SAEs were collected from the time of consent until the participant completed Day 30 or final contact, whichever was longer. For most participants the final visit/contact was at Day 30 (up to 40 days after screening) or later if delayed due to challenges reaching the participant or obtaining final follow-up information (up to Day 251).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
rNAPc2 Lower Dose	5/38 (13.2%)	18/38 (47.4%)	18/38 (47.4%)
rNAPc2 Higher Dose	5/38 (13.2%)	29/38 (76.3%)	18/38 (47.4%)
Heparin	6/80 (7.5%)	26/80 (32.5%)	36/80 (45%)

Most frequent serious events

Showing 10 of 32

Most frequent serious events
Event	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
COVID-19 pneumoniaInfections and infestations	4/38	6/38	5/80
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/38	5/38	4/80
Acute kidney failureRenal and urinary disorders	3/38	2/38	0/80
Acute kidney injuryRenal and urinary disorders	0/38	3/38	2/80
Septic shockInfections and infestations	2/38	0/38	1/80
PneumothoraxRespiratory, thoracic and mediastinal disorders	1/38	0/38	3/80
Respiratory arrestRespiratory, thoracic and mediastinal disorders	0/38	1/38	1/80
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	1/38	0/38	0/80
Chronic kidney diseaseRenal and urinary disorders	1/38	0/38	0/80
Urinary tract infectionInfections and infestations	1/38	0/38	1/80

Most frequent other events

Most frequent other events
Event	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin
Metabolism and nutrition disorderMetabolism and nutrition disorders	2/38	8/38	10/80
COVID-19 PneumoniaInfections and infestations	5/38	4/38	5/80
Respiratory failureRespiratory, thoracic and mediastinal disorders	1/38	5/38	6/80
Acute kidney injryRenal and urinary disorders	3/38	5/38	2/80
Cardiac disordersCardiac disorders	1/38	1/38	7/80
Gastrointestinal disordersGastrointestinal disorders	1/38	3/38	4/80
General disorders and administrative site conditionsGeneral disorders	1/38	3/38	3/80
Vascular disordersVascular disorders	1/38	1/38	5/80
Transaminases increaseInjury, poisoning and procedural complications	2/38	0/38	0/80
Blood and lymphatic system disordersBlood and lymphatic system disorders	2/38	1/38	3/80

Baseline characteristics

The study was designed as a sequential Phase 2B/3 trial whereby both trial phases were nested in a common protocol. When the 2B top line results dictated substantial design changes for progression to Phase 3 the study was concluded as a Phase 2 trial.

Age, Categorical
Age, Categorical(Participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
<=18 years	0	0	0	0
Between 18 and 65 years	30	30	53	113
>=65 years	10	10	27	47

Age, Continuous
Age, Continuous(years)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
Mean	53.9 ± 13.29	52.8 ± 12.6	57.6 ± 12.8	55.5 ± 13

Sex: Female, Male
Sex: Female, Male(Participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
Female	16	21	32	69
Male	24	19	48	91

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
American Indian or Alaska Native	3	0	1	4
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	1	1
Black or African American	10	8	16	34
White	27	32	62	121
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
Argentina	1	1	2	4
United States	38	38	74	150
Brazil	1	1	4	6

WHO COVID Severity
WHO COVID Severity(Participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
Mild	26	22	50	98
Severe	14	18	30	62

D-Dimer (ng/mL)
D-Dimer (ng/mL)(ng/mL)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
Mean	450.8 ± 533.8	517.4 ± 588.3	864.2 ± 1794.8	680.1 ± 1354

D-dimer stratification (%)
D-dimer stratification (%)(Participants)	rNAPc2 Lower Dose	rNAPc2 Higher Dose	Heparin	Total
<= 2x Upper limit of normal	18	20	35	73
> 2x Upper limit of normal	22	20	45	87

1 further baseline measures are reported on the registry.

Study locations

24 sites

ARCA Investigational Site #119
Fairhope, Alabama 36532, United States
ARCA Investigational Site #118
Phoenix, Arizona 85006, United States
ARCA Investigational Site #120
Tucson, Arizona 85724, United States
ARCA Investigational Site #104
Aurora, Colorado 80045, United States
ARCA Investigational Site #117
Denver, Colorado 80204, United States
ARCA Investigational Site #101
Jacksonville, Florida 32209, United States
ARCA Investigational Site #128
Evanston, Illinois 60201, United States
ARCA Investigational Site #113
New Orleans, Louisiana 70121, United States
ARCA Investigational Site #105
Falls Church, Virginia 22042, United States
ARCA Investigational Site #114
Richmond, Virginia 23230, United States
ARCA Investigational Site #103
Tacoma, Washington 98405, United States
ARCA Investigational Site #127
San Nicolás, Buenos Aires, Argentina
ARCA Investigational Site #130
Rosario, Santa Fe, Argentina
ARCA Investigational Site #112
Rosario, Sante Fe, Argentina
ARCA Investigational Site #111
Buenos Aires, Argentina
ARCA Investigational Site #115
Caba, Argentina
ARCA Investigational Site #126
Cordoba, Argentina
ARCA Investigational Site #129
San Miguel de Tucuman, Argentina
ARCA Investigational Site #106
San Miguel De Tucumán, Argentina
ARCA Investigational Site #125
Campo Grande, Mato Grosso Do Sul, Brazil
ARCA Investigational Site #124
Braganca Paulista, Sao Paolo, Brazil
ARCA Investigational Site #122
Sao Jose do Rio Preto, Sao Paolo, Brazil
ARCA Investigational Site #123
Porto Alegre, Brazil
ARCA Investigational Site #121
São Paulo, Brazil

References and documents

Study documents

Study protocol · Jul 7, 2021
Statistical analysis plan · Feb 24, 2022
Informed consent form · Jul 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04655586
Lead sponsor: ARCA Biopharma, Inc.
Collaborators: Colorado Prevention Center
Responsible party: Sponsor
First posted: Dec 7, 2020
Start date: Dec 10, 2020
Primary completion: Dec 6, 2021
Completion: Mar 7, 2022
Results posted: Feb 21, 2023
Last update: Feb 21, 2023

Study contacts

Marc Bonaca, MD, MPH

principal investigator · CPC Clinical Research

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19

Study summary

Conditions studied

Browse trials for

Keywords

In context

COVID-19

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria