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The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible
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The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants ≥ 50 years of age and hospitalized with documented COVID-19 who are not yet in respiratory failure.
After signing informed consent, participants will be screened upon presentation at the hospital. Screening will include full physical examination, vital signs, safety laboratory evaluation, oxygen saturation, pre-diagnostics to measure prostaglandin D2 (PGD2) status, and baseline assessment of World Health Organization (WHO) Ordinal Scale for COVID-19. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will receive the first dose of study medication, PO. The participant will then receive study medication PO or NG (if intubated or unable to swallow medication) once daily, at approximately the same time each day for up to 13 additional days. Study medication will be administered in addition to standard of care deemed appropriate by the treating physician(s). Participants will be randomized to receive BGE-175 or placebo. Participants will be monitored daily for all relevant efficacy outcomes, oxygen saturation, and adverse events. Blood will be drawn periodically for safety laboratory measurements, plasma kinetics, lymphocyte subsets, C-reactive protein, and cytokines. Nasopharyngeal swabs will be collected to measure viral load. Participants will be monitored for 14 days after administration of the last dose (Day 28) and followed through Day 57.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGE-175 | Experimental | BGE-175 tablet to be taken by mouth once a day for 14 days |
|
| Placebo | Placebo Comparator | Placebo tablet to be taken by mouth once a day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGE-175 | Drug | Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Have Died or Progressed to Respiratory Failure | Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage. | First dose date up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Experiencing Treatment-emergent Adverse Events | Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage. | First dose of treatment through study Day 57 |
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Inclusion Criteria:
Ability to voluntarily provide informed consent that is documented per local requirements
An understanding, ability, and willingness to fully comply with study procedures and restrictions
Hospitalized subjects with a confirmed SARS-CoV-2 infection
Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
Age ≥ 50 years
COVID-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%)
Not in respiratory failure as defined by at least one of the following:
Respiratory failure defined by requiring at least one of the following:
Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg) or requiring vasopressors
Multi-organ dysfunction/failure
Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1
Male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies
Exclusion Criteria:
Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Currently participating in a vaccination trial for SARS-CoV-2
Known positive test for influenza A or influenza B at the time of screening
Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment
Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with undetectable viral load, may be enrolled.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN)
Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate [eGFR] < 30 mL/min) or acute renal failure resulting in eGFR < 30 mL/min
Serious comorbidity, including:
History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
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| Name | Affiliation | Role |
|---|---|---|
| Richard G Wilkerson, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Mesa | Arizona | 85202 | United States | ||
| Velocity Clinical Research, Chula Vista |
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There were 223 participants screened for the study. Of these, 194 participants were randomized to received either asapiprant or placebo.
Participants were recruited across 3 countries (US, Brazil and Argentina). Participants were hospitalized with a confirmed lab PCR SARS-COV-2 infection.
First Subject First Visit was on 26 May 2021 and Last Subject Last Visit was on 19May2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asapiprant (BGE-175) | Participants received two 50 mg tablets of asapiprant once daily for 14 days |
| FG001 | Placebo | Participants received two 50 mg tablets of matching placebo tablet daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2021 | Apr 19, 2023 |
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Multicenter, Randomized, Double-blind, Placebo-controlled
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Double-blind
| Other |
Placebo |
|
| Survival |
Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage. |
| Baseline through Day 57; at Day 14, Day 28 and Day 57 |
| Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage. | First dose of treatment through Day 14, Day 28 |
| Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs | Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median) | Baseline through Day 28 |
| Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) | Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | First dose date up to Day 57 |
| Proportion of Patients Who Develop Critical COVID-19 Illness | Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage. | First dose date up to Day 57 |
| Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28) | Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | First dose date up to Day 28 |
| Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | Day 14/End of Treatment, Day 28, Day 57 |
| Number of Patients Who Had Intubation During the Study | Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study. | First dose date up to Day 57 |
| Duration of Intubation | Duration of Intubation (first post-dosing intubation) | First dose date up to Day 57 |
| Time to Discharge From Hospital Intensive Care Unit | Time from intensive care unit admission to the recorded time of intensive care unit discharge | First dose date up to Day 57 |
| Number of Patients Who Had Supplemental Oxygen Administration | Proportion of patients who had any documented post-dosing supplemental O2 administration during the study. | First dose date up to Day 57 |
| Duration of Supplemental Oxygen Administration | Duration of participants receiving supplemental oxygen | First dose date up to Day 57 |
| Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration | Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration. | First dose date up to Day 57 |
| Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula | Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula | First dose date up to Day 57 |
| Number of Patients Who Had Mechanical Ventilation. | Proportion of patients who had any documented post-dosing mechanical ventilation. | First dose date up to Day 57 |
| Duration of Mechanical Ventilation | Duration of participants receiving mechanical ventilation | First dose date up to Day 57 |
| Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO. | Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO. | First dose date up to Day 57 |
| Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO | Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO | First dose date up to Day 57 |
| Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2) | First dose date up to Day 28 |
| Time to Discharge From the Hospital | Length (in days) of the time of hospitalization until medical discharge | First dose date up to Day 57 |
| Number of Patients With Re-hospitalization | Proportion of patients who are hospitalized again after the discharge of first hospitalization. | First dose date up to Day 57 |
| Proportion of Participants Requiring Intensive Care Unit Admission | Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage. | First dose date up to Day 57 |
| Chula Vista |
| California |
| 91911 |
| United States |
| Long Beach Medical Center | Long Beach | California | 90806 | United States |
| UCI Center for Clinical Research | Orange | California | 92868 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Stamford Hospital | Stamford | Connecticut | 06904 | United States |
| University of Florida - Health, Jacksonville | Jacksonville | Florida | 32209 | United States |
| Baptist Health, Lexington | Lexington | Kentucky | 40503 | United States |
| University of Maryland Medical System | Baltimore | Maryland | 21201 | United States |
| Jadestone Clinical Research, LLC | Silver Spring | Maryland | 20904 | United States |
| Clinica Privada Independencia | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Sanatorio De La Trinidad Mitre | Buenos Aires | Buenos Aires F.D. | C1039AAO | Argentina |
| Clinica Adventista Belgrano (CAB) | Buenos Aires | Buenos Aires F.D. | C1430EGF | Argentina |
| Hospital Universitário Cassiano Antônio de Moraes | Vitória | Espírito Santo | 29043-260 | Brazil |
| Hospital Felicio Rocho (HFR) | Belo Horizonte | Minas Gerais | 30180-080 | Brazil |
| Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul | Santa Cruz do Sul | Rio Grande Do Sol | 96835-090 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| Clínica Supera Oncologia | Chapecó | Santa Catarina | 89801-355 | Brazil |
| Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP) | Botucatu | São Paulo | 18618-687 | Brazil |
| Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas | Campinas | São Paulo | 13060-904 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Conjunto Hospitalar de Mandaqui | São Paulo | São Paulo | 02432 | Brazil |
| Clinica de Alergia Martti Antila | Sorocaba | São Paulo | 18040-425 | Brazil |
| Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ) | Rio de Janeiro | 21040-360 | Brazil |
| COMPLETED |
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| NOT COMPLETED |
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|
The Intent-to-Treat (ITT) Analysis Set includes all randomized participants and was used for baseline characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | Asapiprant (BGE-175) | Participants received two 50 mg tablets of asapiprant once daily for 14 days |
| BG001 | Placebo | Participants received two 50 mg tablets of matching placebo tablet daily for 14 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline WHO ordinal scale | WHO scale is as follows: 0) Uninfected 1) Ambulatory with no limitation of activities 2) Ambulatory with limitation of activities 3) Hospitalized, mild disease with no oxygen therapy 4) Hospitalized, mild disease with oxygen by mask or nasal prongs 5) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6) Hospitalized, severe disease with intubation and mechanical ventilation 7) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8) Death. Higher score means worse outcome. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Have Died or Progressed to Respiratory Failure | Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the primary efficacy analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 28 |
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| Secondary | Proportion of Participants Experiencing Treatment-emergent Adverse Events | Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose of treatment through study Day 57 |
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| Secondary | Survival | Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. Subjects who discontinued the study prior to the timepoint are censored at the date of discontinuation and excluded from the analysis. At Day 57, the number participants analyzed were different because 9 participants were censored from the asapiprant arm and 15 participants from the placebo arm. | Posted | Count of Participants | Participants | Baseline through Day 57; at Day 14, Day 28 and Day 57 |
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| Secondary | Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | First dose of treatment through Day 14, Day 28 |
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| Secondary | Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs | Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median) | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Median | 95% Confidence Interval | days | Baseline through Day 28 |
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| Secondary | Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) | Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Median | 95% Confidence Interval | days | First dose date up to Day 57 |
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| Secondary | Proportion of Patients Who Develop Critical COVID-19 Illness | Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28) | Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Median | 95% Confidence Interval | days | First dose date up to Day 28 |
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| Secondary | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | score on a scale | Day 14/End of Treatment, Day 28, Day 57 |
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| Secondary | Number of Patients Who Had Intubation During the Study | Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Duration of Intubation | Duration of Intubation (first post-dosing intubation) | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | Days | First dose date up to Day 57 |
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| Secondary | Time to Discharge From Hospital Intensive Care Unit | Time from intensive care unit admission to the recorded time of intensive care unit discharge | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Number of Patients Who Had Supplemental Oxygen Administration | Proportion of patients who had any documented post-dosing supplemental O2 administration during the study. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Duration of Supplemental Oxygen Administration | Duration of participants receiving supplemental oxygen | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration | Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula | Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Number of Patients Who Had Mechanical Ventilation. | Proportion of patients who had any documented post-dosing mechanical ventilation. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. This outcome is based on subjects who had WHO ordinal scale score of 6. A subject can have either a score of 6 or 7 (see outcome measure: Duration of Mechanical Ventilation Plus Additional Organ Support) but not both. This is the reason for the differing numbers for outcome 17 and 19. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Duration of Mechanical Ventilation | Duration of participants receiving mechanical ventilation | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO. | Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. This outcome is based on subjects who had WHO ordinal scale score of 7. A subject can have either a score of 6 (see outcome measure: Duration of Mechanical Ventilation) or 7 but not both. This is the reason for the differing numbers for outcome 17 and 19. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO | Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2) | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | Ratio SpO2/FiO2 | First dose date up to Day 28 |
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| Secondary | Time to Discharge From the Hospital | Length (in days) of the time of hospitalization until medical discharge | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Mean | Standard Deviation | days | First dose date up to Day 57 |
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| Secondary | Number of Patients With Re-hospitalization | Proportion of patients who are hospitalized again after the discharge of first hospitalization. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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| Secondary | Proportion of Participants Requiring Intensive Care Unit Admission | Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage. | The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. | Posted | Count of Participants | Participants | First dose date up to Day 57 |
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From first dose of treatment through Study Day 57
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asapiprant | Participants received two 50 mg tablets of asapiprant once daily for 14 days | 16 | 96 | 34 | 96 | 34 | 96 |
| EG001 | Placebo | Participants received two 50 mg tablets of matching placebo tablet daily for 14 days | 10 | 98 | 32 | 98 | 32 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Severe acute respiratory syndrome | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Cardiac output decreased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.1) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Martin, M.D. | BioAge Labs, Inc. | 215-260-5134 | patrick@bioagelabs.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2022 | Apr 19, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712667 | asapiprant |
Not provided
Not provided
Not provided
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Not Reported |
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| South America |
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| WHO ordinal scale score 4 |
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| WHO ordinal scale score 5 |
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|---|---|
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Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
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