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To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not requiring mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efzofitimod 1 mg/kg | Experimental | Participants will receive single dose of efzofitimod 1 milligrams/kilograms (mg/kg) IV infusion on Day 1. |
|
| Efzofitimod 3 mg/kg | Experimental | Participants will receive single dose of efzofitimod 3 mg/kg IV infusion on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to efzofitimod IV infusion on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efzofitimod 1 mg/kg | Drug | Concentrate for solution for infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. | Baseline up to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hospital Discharge | Time to hospital discharge was based on Kaplan-Meier estimate and was calculated as: discharge date - study drug administration date. Participants who died during hospitalization were censored at death date. Participants who remained hospitalized at end of study (EOS) were censored at EOS visit. | Baseline up to Day 60 |
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Inclusion Criteria:
Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).
Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected respiratory infection with radiographic abnormalities suggestive of viral pneumonia, plus at least 1 of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| aTyr Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Efzofitimod 1 mg/kg | Participants received single dose of efzofitimod 1 milligrams/kilograms (mg/kg) intravenous (IV) infusion on Day 1. |
| FG001 | Efzofitimod 3 mg/kg | Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1. |
| 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 | Nov 13, 2020 | Jun 27, 2023 |
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Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
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The Investigator, Sponsor, and participant will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
| Efzofitimod 3 mg/kg |
| Drug |
Concentrate for solution for infusion |
|
| Placebo | Drug | Concentrate for solution for infusion |
|
| Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3) | Time to recovery was based on Kaplan-Meier estimate and was calculated as: date of first time with a WHO scale score ≤3 - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach WHO scale score ≤3 criteria, the participant was censored at EOS visit. | Baseline up to Day 60 |
| Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28 | The number of participants was the non-missing value at the visit, which was used as the denominator for percentage calculation. | Baseline through Day 14 and Day 28 |
| Number of Days With Supplemental Oxygen (O2) | Number of days with supplemental O2 was calculated as stop date of supplemental O2 - start date of supplemental oxygen +1, if supplemental O2 started after study drug administration; otherwise, number of days with supplemental O2 was calculated as stop date of supplemental O2 - date of study drug administration +1. If there were multiple periods of supplemental O2, total days were the sum of each period. | Baseline up to Day 60 |
| Number of Days With Fever (Temperature >100.4ºF [38.0ºC]) | Number of days with fever was calculated as stop date of fever - start date of fever +1, if fever started after study drug administration; otherwise, number of days with fever was calculated as stop date of fever - date of study drug administration +1. If there were multiple periods of fever, total days was the sum of each period. | Baseline up to Day 14 |
| Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60 | WHO ordinal scale rated the clinical improvement of the participants on a scale of 0-8, where 0=No clinical or virological evidence of infection, 1=No limitation of activities, 2=limitation of activities, 3=Hospitalized, no oxygen therapy, 4=Oxygen by mask or nasal prongs, 5=Non-invasive ventilation or high flow oxygen, 6=Intubation and mechanical ventilation, 7=Ventilation + additional organ support, 8=Death. Change from Baseline data were represented on a scale of -7 to 4, where -7=a better change from Baseline score and 4=a worse change from Baseline score. Change from Baseline was derived as: visit value - Baseline value. | Baseline, Day 60 |
| Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score | Time to improvement was based on Kaplan-Meier estimate and was defined as the date of decrease in WHO scale compared to Baseline by at least 1 point - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach an improvement, the participant was censored at end of study date. | Baseline up to Day 60 |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Miami | Miami | Florida | 33125 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| aTyr Investigative Site | Vineland | New Jersey | 08360 | United States |
| aTyr Investigative Site | Toledo | Ohio | 43614 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Alliance Medical Service, Cardio Pulmonary Research | Guaynabo | 00968 | Puerto Rico |
| Manati Medical Center | Manati | 00674 | Puerto Rico |
| FG002 | Placebo | Participants received placebo matched to efzofitimod IV infusion on Day 1. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Efzofitimod 1 mg/kg | Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1. |
| BG001 | Efzofitimod 3 mg/kg | Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1. |
| BG002 | Placebo | Participants received placebo matched to efzofitimod IV infusion on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section. | Safety Set was included all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group). | Posted | Count of Participants | Participants | Baseline up to Day 60 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Hospital Discharge | Time to hospital discharge was based on Kaplan-Meier estimate and was calculated as: discharge date - study drug administration date. Participants who died during hospitalization were censored at death date. Participants who remained hospitalized at end of study (EOS) were censored at EOS visit. | Modified intention-to-treat set (mITT Set) included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 60 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3) | Time to recovery was based on Kaplan-Meier estimate and was calculated as: date of first time with a WHO scale score ≤3 - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach WHO scale score ≤3 criteria, the participant was censored at EOS visit. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 60 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28 | The number of participants was the non-missing value at the visit, which was used as the denominator for percentage calculation. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). Here, Number of Participants Analyzed signifies those who were evaluable for this outcome measure and Number Analyzed signifies those who were evaluable at the specified timepoint. | Posted | Count of Participants | Participants | Baseline through Day 14 and Day 28 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Supplemental Oxygen (O2) | Number of days with supplemental O2 was calculated as stop date of supplemental O2 - start date of supplemental oxygen +1, if supplemental O2 started after study drug administration; otherwise, number of days with supplemental O2 was calculated as stop date of supplemental O2 - date of study drug administration +1. If there were multiple periods of supplemental O2, total days were the sum of each period. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). | Posted | Mean | Standard Deviation | days | Baseline up to Day 60 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Days With Fever (Temperature >100.4ºF [38.0ºC]) | Number of days with fever was calculated as stop date of fever - start date of fever +1, if fever started after study drug administration; otherwise, number of days with fever was calculated as stop date of fever - date of study drug administration +1. If there were multiple periods of fever, total days was the sum of each period. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). | Posted | Mean | Standard Deviation | days | Baseline up to Day 14 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60 | WHO ordinal scale rated the clinical improvement of the participants on a scale of 0-8, where 0=No clinical or virological evidence of infection, 1=No limitation of activities, 2=limitation of activities, 3=Hospitalized, no oxygen therapy, 4=Oxygen by mask or nasal prongs, 5=Non-invasive ventilation or high flow oxygen, 6=Intubation and mechanical ventilation, 7=Ventilation + additional organ support, 8=Death. Change from Baseline data were represented on a scale of -7 to 4, where -7=a better change from Baseline score and 4=a worse change from Baseline score. Change from Baseline was derived as: visit value - Baseline value. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline, Day 60 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score | Time to improvement was based on Kaplan-Meier estimate and was defined as the date of decrease in WHO scale compared to Baseline by at least 1 point - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach an improvement, the participant was censored at end of study date. | mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). | Posted | Median | 95% Confidence Interval | days | Baseline up to Day 60 |
|
Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
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 | Efzofitimod 1 mg/kg | Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1. | 2 | 10 | 5 | 10 | 8 | 10 |
| EG001 | Efzofitimod 3 mg/kg | Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | Placebo | Participants received placebo matched to efzofitimod IV infusion on Day 1. | 0 | 10 | 0 | 10 | 7 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatitis B virus test positive | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Prothrombin time ratio increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | aTyR Pharma | 858 731 8389 | clinicaltrials@atyrpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2019 | Jun 27, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| 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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Placebo |
Participants received placebo matched to efzofitimod IV infusion on Day 1. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|