Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)
Verified date | February 2023 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in hospitalized patients with Coronavirus Disease 2019 (COVID-19).
Status | Completed |
Enrollment | 449 |
Est. completion date | March 7, 2022 |
Est. primary completion date | March 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory - Admitted to the hospital within 36 hours - Oxygen saturation of hemoglobin by pulse oximetry at room air =94% - For patients admitted WITH respiratory symptoms, enrollment must occur within 36 hours of hospital admission. If the patient is admitted to the hospital with normal saturations, but develops respiratory symptoms DURING their hospital stay, enrollment may occur within 24 hours of desaturation to 94% or less on room air - Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure Exclusion Criteria: - Hypersensitivity to vadadustat or any of its excipients - Placed on mechanical ventilation before randomization - Hemoglobin above the gender-specific upper limit of normal (ULN) at randomization: 16 g/dL for females and 18 g/dL for males - Patients who have erythrocytosis or polycythemia vera - Patient taking Probenecid, lopinavir or ritonavir - Women who are pregnant or breastfeeding, or positive pregnancy test before randomization - Patients not on maintenance dialysis with eGFC < 31 ml/min - Patients who have received a solid organ transplant, heart, kidney, liver or lung - Patients who are prisoners - Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI) - Patients with modified Rankin scale of 3 or greater - Patient who are currently enrolled in any other interventional clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | Akebia Therapeutics Inc., United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Score on the Modified Sequential Organ Failure Assessment (MSOFA) scale | Modified Sequential Organ Failure Assessment (MSOFA) scale:
Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (= 400); 2 (= 315); 3 (= 235); 4 (= 150) Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine = 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine = 0.1, Norepinephrine = 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1) Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6) Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0) |
day 7 | |
Other | Score on the Modified Sequential Organ Failure Assessment (MSOFA) scale | Modified Sequential Organ Failure Assessment (MSOFA) scale:
Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (= 400); 2 (= 315); 3 (= 235); 4 (= 150) Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine = 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine = 0.1, Norepinephrine = 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1) Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6) Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0) |
day 14 | |
Other | Ventilator-free survival | day 7 | ||
Other | Ventilator-free survival | day 14 | ||
Other | Overall survival | day 7 | ||
Other | Overall survival | day 14 | ||
Other | Number of participants with hypotension | Hypotension is defined as Mean Arterial Pressure (MAP) <70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure. | day 7 | |
Other | Number of participants with hypotension | Hypotension is defined as Mean Arterial Pressure (MAP) <70 mm Hg or requirement for inotropes or vasopressors to maintain blood pressure. | day 14 | |
Other | Number of participants with acute kidney injury | day 7 | ||
Other | Number of participants with acute kidney injury | day 14 | ||
Other | Time to hospital discharge | From the time of hospital admission to hospital discharge (about 7 days) | ||
Primary | Number of participants who are classified 8 (dead), 7 (hospitalized, on invasive mechanical ventilation or ECMO), or 6 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the NIAID ordinal scale | National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS):
8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities |
day 14 | |
Secondary | Number of participants with a total score of 0 on the Modified Sequential Organ Failure Assessment (MSOFA) scale | Modified Sequential Organ Failure Assessment (MSOFA) scale:
Each of 5 organ systems is given a score of 0 to 4, as detailed below. The MSOFA scale total score is the sum of the score for the 5 organ systems. Discharged patients will be assigned a score of 0 and dead patients a score of 20. Respiratory oxygen saturation(SpO2)/concentration of oxygen that a person inhales(FiO2): 0 (> 400); 1 (= 400); 2 (= 315); 3 (= 235); 4 (= 150) Liver: 0 (No scleral icterus or jaundice); 3 (Scleral icterus or jaundice) Cardiovascular, hypotension: 0 (No hypotension); 1 (MAP < 70 mm Hg); 2 (Dopamine = 5 or dobutamine any dose); 3 (Dopamine > 5, Epinephrine = 0.1, Norepinephrine = 0.1); 4 (Dopamine > 15, Epinephrine > 0.1, Norepinephrine > 0.1) Central Nervous System (CNS), Glasgow Coma Score: 0 (15), 1 (13 - 14); 2 (10 - 12); 3 (6 - 9); 4 (< 6) Renal, Creatinine mg/dL: 0 (< 1.2); 1 (1.2 - 1.9); 2 (2.0 - 3.4); 3 (3.5 - 4.9); 4 (> 5.0) |
day 14 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04695392 -
Restore Resilience in Critically Ill Children
|
N/A | |
Terminated |
NCT04972318 -
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
|
N/A | |
Completed |
NCT04534569 -
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
|
||
Completed |
NCT04078984 -
Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
|
||
Completed |
NCT04451291 -
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
|
N/A | |
Not yet recruiting |
NCT06254313 -
The Role of Cxcr4Hi neutrOPhils in InflueNza
|
||
Not yet recruiting |
NCT04798716 -
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04909879 -
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT02881385 -
Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation
|
N/A | |
Terminated |
NCT02867228 -
Noninvasive Estimation of Work of Breathing
|
N/A | |
Completed |
NCT02545621 -
A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
|
||
Withdrawn |
NCT02253667 -
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
|
N/A | |
Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
Withdrawn |
NCT01927237 -
Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide
|
N/A | |
Completed |
NCT02889770 -
Dead Space Monitoring With Volumetric Capnography in ARDS Patients
|
N/A | |
Completed |
NCT01504893 -
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
|
N/A | |
Completed |
NCT01680783 -
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A |