NCT04705597

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

Terminated Phase 2 Results posted Last updated 3 July 2023

What this trial tests

Phase 2 trial testing BGE-175 in Covid19 in 194 participants. Terminated before completion.

Timeline

18 March 2021

Primary endpoint
20 April 2022

19 May 2022

Quick facts

Lead sponsor	BioAge Labs, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	194
Start date	18 March 2021
Primary completion	20 April 2022
Estimated completion	19 May 2022
Sites	26 locations across Argentina, United States, Brazil

Drugs / interventions tested

• BGE-175 — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

BioAge Labs, Inc. — full company profile →

Who can join

50 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Who Have Died or Progressed to Respiratory Failure Primary · 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.

Group	Value	95% CI
Asapiprant (BGE-175)	31
Placebo	26

Proportion of Participants Experiencing Treatment-emergent Adverse Events Secondary · First dose of treatment through study Day 57

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.

Group	Value	95% CI
Asapiprant (BGE-175)	73
Placebo	71

Survival Secondary · Baseline through Day 57; at Day 14, Day 28 and Day 57

Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.

Survival at Day 14

Group	Value	95% CI
Asapiprant (BGE-175)	89
Placebo	93

Survival at Day 28

Group	Value	95% CI
Asapiprant (BGE-175)	79
Placebo	87

Survival at Day 57

Group	Value	95% CI
Asapiprant (BGE-175)	69
Placebo	72

Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 Secondary · First dose of treatment through Day 14, Day 28

Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage.

Day 14

Group	Value	95% CI
Asapiprant (BGE-175)	69.5	59.1 – 77.7
Placebo	78.6	69.0 – 85.5

Day 28

Group	Value	95% CI
Asapiprant (BGE-175)	67.3	56.9 – 75.8
Placebo	73.4	63.4 – 81.0

Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs Secondary · Baseline through Day 28

Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)

Group	Value	95% CI
Asapiprant (BGE-175)	29	29 – NA
Placebo	29	29 – NA

Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) Secondary · First dose date up to Day 57

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 mas

Group	Value	95% CI
Asapiprant (BGE-175)	NA	NA – NA
Placebo	NA	NA – NA

Proportion of Patients Who Develop Critical COVID-19 Illness Secondary · First dose date up to Day 57

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

Group	Value	95% CI
Asapiprant (BGE-175)	34
Placebo	28

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) Secondary · First dose date up to 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 diseas

Group	Value	95% CI
Asapiprant (BGE-175)	8	6.0 – 10.0
Placebo	6	5.0 – 9.0

Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score Secondary · Day 14/End of Treatment, Day 28, Day 57

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 oxyg

Change at Day 14

Group	Value	95% CI
Asapiprant (BGE-175)	-1.2	± 2.17
Placebo	-1.8	± 1.76

Change at Day 28

Group	Value	95% CI
Asapiprant (BGE-175)	-1.2	± 2.51
Placebo	-1.7	± 2.11

Change at Day 57

Group	Value	95% CI
Asapiprant (BGE-175)	-2.7	± 0.58
Placebo	-2.8	± 0.42

Number of Patients Who Had Intubation During the Study Secondary · First dose date up to Day 57

Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.

Group	Value	95% CI
Asapiprant (BGE-175)	18
Placebo	10

Duration of Intubation Secondary · First dose date up to Day 57

Duration of Intubation (first post-dosing intubation)

Group	Value	95% CI
Asapiprant (BGE-175)	11.8	± 5.32
Placebo	7.8	± 7.96

Time to Discharge From Hospital Intensive Care Unit Secondary · First dose date up to Day 57

Time from intensive care unit admission to the recorded time of intensive care unit discharge

Group	Value	95% CI
Asapiprant (BGE-175)	15.7	± 7.67
Placebo	12.1	± 8.55

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of treatment through Study Day 57. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Asapiprant

Serious: 34/96 (35%)

Deaths: 16/96

Placebo

Serious: 32/98 (33%)

Deaths: 10/98

Serious adverse events (50 terms)

Reaction	System	Asapiprant	Placebo
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Septic shock	Infections and infestations	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary sepsis	Infections and infestations	—	—
Pneumonia bacterial	Infections and infestations	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Bronchopulmonary aspergillosis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	—	—
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	—	—
Urosepsis	Infections and infestations	—	—
Bacterial sepsis	Infections and infestations	—	—
COVID-19	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Bacterial infection	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Enterococcal sepsis	Infections and infestations	—	—
Fungaemia	Infections and infestations	—	—
Necrotising fasciitis	Infections and infestations	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Asapiprant	Placebo
Constipation	Gastrointestinal disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Atrial fibrillation	Cardiac disorders	—	—
Pyrexia	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—

Most-reported serious reactions: Respiratory failure, Septic shock, Acute kidney injury, Pulmonary embolism, Pulmonary sepsis, Pneumonia bacterial, Hypoxia, Bronchopulmonary aspergillosis.

Data from ClinicalTrials.gov NCT04705597 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Eicosanoid signalling blockade protects middle-aged mice from severe COVID-19.
   Wong LR, Zheng J, Wilhelmsen K, Li K, et al · · 2022 · cited 170× · PMID 35314834 · DOI 10.1038/s41586-022-04630-3
2. The roles of lipids in SARS-CoV-2 viral replication and the host immune response.
   Theken KN, Tang SY, Sengupta S, FitzGerald GA. · · 2021 · cited 59× · PMID 34599996 · DOI 10.1016/j.jlr.2021.100129
3. Animal models of SARS-CoV-2 and COVID-19 for the development of prophylactic and therapeutic interventions.
   Renn M, Bartok E, Zillinger T, Hartmann G, et al · · 2021 · cited 20× · PMID 34171328 · DOI 10.1016/j.pharmthera.2021.107931
4. Emerging small molecule antivirals may fit neatly into COVID-19 treatment.
   Fenton C, Keam SJ. · · 2022 · cited 14× · PMID 35250258 · DOI 10.1007/s40267-022-00897-8
5. Effects of non-steroidal anti-inflammatory drugs and other eicosanoid pathway modifiers on antiviral and allergic responses: EAACI task force on eicosanoids consensus report in times of COVID-19.
   Sokolowska M, Rovati GE, Diamant Z, Untersmayr E, et al · · 2022 · cited 13× · PMID 35174512 · DOI 10.1111/all.15258
6. Nonsteroidal anti-inflammatory drugs and glucocorticoids in COVID-19.
   Ricciotti E, Laudanski K, FitzGerald GA. · · 2021 · cited 11× · PMID 34303107 · DOI 10.1016/j.jbior.2021.100818
7. Prostaglandins in the Inflamed Central Nervous System: Potential Therapeutic Targets.
   Sheremeta CL, Yarlagadda S, Smythe ML, Noakes PG. · · 2024 · cited 8× · PMID 39177131 · DOI 10.2174/0113894501323980240815113851
8. Lipid metabolism, viral infection, and antiviral immunity: a new host-pathogen interface.
   Yang LJ, Tang M, Yang L. · · 2026 · PMID 41868152 · DOI 10.3389/fcimb.2026.1765502