Covid19Phase 2NCT04705597
Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure
A Phase 2 study testing BGE-175 in people with Covid19, run by BioAge Labs, Inc. at 26 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- BGE-175
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 18 Mar 2021to 19 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
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- Not in respiratory failure as defined by at least one of the following:
- Respiratory failure defined by requiring at least one of the following:
- Endotracheal intubation and mechanical ventilation
- Oxygen delivered by high-flow nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5)
- NIPPV
- ECMO
- Clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting)
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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:
- Myocardial infarction (within the last month)
- Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
- Acute stroke (within the last month)
- Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are not considered in remission, or solid tumor or hematological malignancies with evidence of disease progression in the past 3 months (i.e., there is evidence of disease progression by Response Evaluation Criteria in Solid Tumours [RECIST] or equivalent relevant criterion for the type of malignancy), and are not considered effectively managed with ongoing treatment as determined by the investigator
- Recent severe thromboembolic disease or evidence of severe thromboembolic disease defined as a current large vessel thromboembolic event or a thromboembolic event within the past 3 months (e.g., deep vein thrombosis [DVT], pulmonary embolism, ischemic stroke, transient ischemic attack) requiring interventional treatment. This exclusion does not prohibit prophylaxis for thromboembolic events, including those considered possible with concurrent SARS-CoV-2 infection.
- 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
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
Brazil12 sites
Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Hospital Felicio Rocho (HFR)
Belo Horizonte, Minas Gerais, 30180-080
Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)
Botucatu, São Paulo, 18618-687
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas
Campinas, São Paulo, 13060-904
Clínica Supera Oncologia
Chapecó, Santa Catarina, 89801-355
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093
Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro, 21040-360
Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, Rio Grande Do Sol, 96835-090
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Conjunto Hospitalar de Mandaqui
São Paulo, São Paulo, 02432
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425
Hospital Universitário Cassiano Antônio de Moraes
Vitória, Espírito Santo, 29043-260
United States11 sites
University of Maryland Medical System
Baltimore, Maryland, 21201
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
North Colorado Medical Center
Greeley, Colorado, 80631
University of Florida - Health, Jacksonville
Jacksonville, Florida, 32209
Baptist Health, Lexington
Lexington, Kentucky, 40503
Long Beach Medical Center
Long Beach, California, 90806
Banner Health
Mesa, Arizona, 85202
UCI Center for Clinical Research
Orange, California, 92868
Sharp Memorial Hospital
San Diego, California, 92123
Jadestone Clinical Research, LLC
Silver Spring, Maryland, 20904
Stamford Hospital
Stamford, Connecticut, 06904
Argentina3 sites
Sanatorio De La Trinidad Mitre
Buenos Aires, Buenos Aires F.D., C1039AAO
Clinica Adventista Belgrano (CAB)
Buenos Aires, Buenos Aires F.D., C1430EGF
Clinica Privada Independencia
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19
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.
Read the detailed description
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.
- Conditions
- Covid19
- Being tested
- BGE-175, Placebo
- Keywords
- COVID-19, BGE-175, BioAge, Respiratory failure
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGE-175Drug
Drug
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BGE-175 | Experimental | BGE-175 tablet to be taken by mouth once a day for 14 days Receives: Drug: BGE-175 |
| Placebo | Placebo comparator | Placebo tablet to be taken by mouth once a day for 14 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First dose date up to Day 28
Secondary outcomes (23)
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.
Measured: First dose of treatment through study Day 57
Survival
Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First dose date up to Day 57
Duration of Intubation
Duration of Intubation (first post-dosing intubation)
Measured: 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
Measured: 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.
Measured: First dose date up to Day 57
Duration of Supplemental Oxygen Administration
Duration of participants receiving supplemental oxygen
Measured: 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.
Measured: 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
Measured: 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.
Measured: First dose date up to Day 57
Duration of Mechanical Ventilation
Duration of participants receiving mechanical ventilation
Measured: 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.
Measured: 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
Measured: 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)
Measured: First dose date up to Day 28
Time to Discharge From the Hospital
Length (in days) of the time of hospitalization until medical discharge
Measured: 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.
Measured: 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.
Measured: First dose date up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start18 Mar 2021
- Primary completion20 Apr 2022
- Study completion19 May 2022
Why it stopped: The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-blind, Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard G Wilkerson, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705597
- Sponsor's protocol ID
- BGE-175-201
- Status last verified
- Jun 2023
- First submitted
- 4 Jan 2021
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19
- ClinicalTrials.gov ID
- NCT04705597
- Acronym / sponsor ID
- BGE-175-201
- Conditions
- Covid19
- Keywords
- COVID-19, BGE-175, BioAge, Respiratory failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| BGE-175 | Experimental | Drug: BGE-175BGE-175 tablet to be taken by mouth once a day for 14 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet to be taken by mouth once a day for 14 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGE-175Drug | Drug | BGE-175 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Proportion of Participants Who Have Died or Progressed to Respiratory Failure
Time frame: First dose date up to Day 28
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.
23 secondary outcomes
Proportion of Participants Experiencing Treatment-emergent Adverse Events
Time frame: First dose of treatment through study Day 57
Survival
Time frame: 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
Time frame: First dose of treatment through Day 14, Day 28
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs
Time frame: 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)
Time frame: First dose date up to Day 57
Proportion of Patients Who Develop Critical COVID-19 Illness
Time frame: 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)
Time frame: First dose date up to Day 28
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score
Time frame: Day 14/End of Treatment, Day 28, Day 57
Number of Patients Who Had Intubation During the Study
Time frame: First dose date up to Day 57
Duration of Intubation
Time frame: First dose date up to Day 57
Time to Discharge From Hospital Intensive Care Unit
Time frame: First dose date up to Day 57
Number of Patients Who Had Supplemental Oxygen Administration
Time frame: First dose date up to Day 57
Duration of Supplemental Oxygen Administration
Time frame: First dose date up to Day 57
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration
Time frame: First dose date up to Day 57
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula
Time frame: First dose date up to Day 57
Number of Patients Who Had Mechanical Ventilation.
Time frame: First dose date up to Day 57
Duration of Mechanical Ventilation
Time frame: 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.
Time frame: 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
Time frame: First dose date up to Day 57
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)
Time frame: First dose date up to Day 28
Time to Discharge From the Hospital
Time frame: First dose date up to Day 57
Number of Patients With Re-hospitalization
Time frame: First dose date up to Day 57
Proportion of Participants Requiring Intensive Care Unit Admission
Time frame: First dose date up to Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard G Wilkerson, MD principal investigator
University of Maryland, Baltimore
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGE-175 in people with Covid19, run by BioAge Labs, Inc. at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Brazil, United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Who Have Died or Progressed to Respiratory Failure (time frame: First dose date up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.