COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04483960

Grace McPhee

grace.mcphee@unimelb.edu.au

2020-07-23

Recruiting

RCT

Randomized

Factorial

Open label

multi-center

Treatment

platform inclusion criteria: age ≥ 18 years admitted to an acute-care hospital confirmed sars-cov-2 by nucleic acid testing or rapid antigen testing in the 14 days prior to randomisation able to be randomised within 14 days of symptom onset at least one symptom or sign attributable to sars-cov-2 infection

a. overall platform exclusions: currently receiving acute intensive respiratory support (invasive or non-invasive mechanical ventilation) or vasopressor/inotropic support. note, participants already on community based non-invasive ventilation (either cpap or bipap) can still be recruited. humidified high flow nasal oxygen will not be considered an exclusion criterion. previous participation in the trial treating team deems enrolment in the study is not in the best interests of the patient death is deemed to be imminent and inevitable within the next 24 hours either the patient or their primary treating clinician are not committed to active treatment. this criterion seeks to exclude those patients where supportive comfort measures only are being provided. patients who are planned for active ward management with a clear aim to improve survival, even if intensive care unit level support is not being offered, should still be included. b. domain a (antiviral) intervention-level exclusions: criteria that exclude a patient from one or more interventions are: nafamostat: known current decompensated liver disease (child-pugh b or c) the treating clinician intends to continue or commence therapeutic anticoagulation a current or recurrent condition with a high risk of major bleeding (e.g. bleeding disorder), or a baseline coagulation profile (within the previous 3 days) that indicates a high risk of bleeding, that would be considered a contraindication to receive therapeutic anticoagulation serum potassium >5.5 mmol/l (based on most recent blood test result collected as part of routine care within the previous 3 days) serum sodium <120 mmol/l (based on most recent blood test result collected as part of routine care within the previous 3 days) hypersensitivity to nafamostat pregnancy or breastfeeding currently receiving or have received nafamostat in the past 7 days decompensated heart failure or renal dialysis and clinician believes an extra 500ml fluid/day would be detrimental there are no domain-level exclusions for the antiviral domain. c. domain b (antibody - hyperimmunoglobulin or standard care) specific exclusions: participant has already received treatment with sars-cov-2-specific immunoglobulin therapy (convalescent plasma, hyperimmune globulin or monoclonal antibody) within 3 months prior to enrolment treating team deems enrolment in antibody intervention is not in the best interests of the patient. participant has received a sars-cov-2 vaccine within the prior 30 days known previous history of serious allergic reaction to blood product transfusion, intravenous immunoglobulin or other injectable form of igg will exclude a patient from hyperimmune globulin known personal or religious objections to receiving blood products will exclude a patient from hyperimmune globulin pregnant or breastfeeding female participants will be excluded from hyperimmune globulin prior history of a thrombotic event (including acute coronary syndromes, cerebrovascular syndromes, pulmonary or deep vein thrombosis) within the prior 30 days of randomisation will exclude a patient from receiving hyperimmune globulin having a creatinine clearance of less than 50ml/min will exclude a patient from receiving hyperimmune globulin d. domain c (anticoagulation) domain-level exclusions: patients will be excluded from this domain if they have any of the following: receiving dual antiplatelet therapy the treating clinician intends to continue or commence therapeutic anticoagulation contraindication to receiving low molecular weight heparin or unfractionated heparin, including the known or suspected history of heparin-induced thrombocytopenia or other adverse reaction to prior heparin exposure such as hypersensitivity severe thrombocytopenia (platelet count less than 530 x 109/l) history of intracranial haemorrhage in the previous 3 months severe renal impairment, defined as estimated glomerular filtration rate less than 15ml/min/1.73m2 a current or recurrent condition with a high risk of major bleeding (e.g. bleeding disorder), or a baseline coagulation profile (within the previous 3 days) that indicates a high risk of bleeding, that would be considered a contraindication to receive therapeutic anticoagulation

6

University of Melbourne

18

100

Australia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

2400

Death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support.

None

Phase 3

[{"arm_notes": "standard dose thromboprophylaxis ;Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 1497, "treatment_name": "Dalteparin+enoxaparin+tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "intermediate dose thromboprophylaxis;Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 1497, "treatment_name": "Dalteparin+enoxaparin+tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 1498, "treatment_name": "Aspirin+dalteparin+enoxaparin+tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Duplicate ACTRN12620000445976, information retrieved from both registries entries.", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]