Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04478071
Other study ID # HSC-MS-20-0395
Secondary ID W81XWH-21-10032
Status Completed
Phase Phase 2
First received
Last updated
Start date August 22, 2020
Est. completion date March 7, 2022

Study information

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

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
vadadustat
Participants will receive vadadustat once daily for 14 days.
placebo
Participants will receive matching placebo once daily for 14 days.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Akebia Therapeutics Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  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