v3.0.7
Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT02735707 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
info@remapcap.org |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
25/03/2020 |
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Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Factorial |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
remap-cap platform inclusion criteria: adult patient admitted to an icu for severe cap within 48 hours of hospital admission with: symptoms or signs or both that are consistent with lower respiratory tract infection and radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate) up to 48 hours after icu admission, receiving organ support with one or more of: non-invasive or invasive ventilatory support; receiving infusion of vasopressor or inotropes or both platform |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
healthcare-associated pneumonia: prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days resident of a nursing home or long term care facility death is deemed to be imminent and inevitable during the next 24 hours and one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment previous participation in this remap within the last 90 days remap-covid platform inclusion criteria 1. adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection. remap-covid platform exclusion criteria death is deemed to be imminent and inevitable during the next 24 hours and one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment patient is expected to be discharged from hospital today or tomorrow more than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection. previous participation in this remap within the last 90 days domain-specific eligible criteria: each domain may have additional eligibility criteria. refer to the study website for more information (www.remapcap.org). |
|
Number of arms
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
16 |
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Funding
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
UMC Utrecht |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Australia;Belgium;Canada;Colombia;Croatia;Germany;Hungary;India;Ireland;Japan;Nepal;Netherlands;New Zealand;Pakistan;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
10000 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Days alive and not receiving organ support in ICU;All-cause mortality |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : June 6, 2023, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 732, "treatment_name": "Levofloxacin or moxifloxacin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 603, "treatment_name": "Hydrocortisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 937, "treatment_name": "Oseltamivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1339, "treatment_name": "Unfractioned heparin or low molecular weight heparin (lmwh)", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1200, "treatment_name": "Simvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 775, "treatment_name": "Mechanical ventilation", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1851, "treatment_name": "Eritoran", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1410, "treatment_name": "Ace inhibitor+angiotensin receptor blocker (arb)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2740, "treatment_name": "Cysteamine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}] |