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The study was terminated by Sponsor due to low enrollment.
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This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease.
All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamrevlumab | Experimental | Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
|
| Placebo | Experimental | Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamrevlumab | Drug | Sterile liquid for injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28 | Day 28 | |
| Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14 | Day 14 |
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Inclusion Criteria:
Confirmed SARS-CoV-2 infection
Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:
Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Detroit | Michigan | 48202 | United States | ||
| Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pamrevlumab | Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| FG001 | Placebo | Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population: All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pamrevlumab | Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| BG001 | Placebo | Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28 | ITT Population: All randomized participants. | Posted | Count of Participants | Participants | Day 28 |
|
Baseline up to Day 28
Serious and Other (Not Including Serious) Adverse Events were monitored/assessed for the Safety Population and All-Cause Mortality was monitored/assessed for ITT Population. The ITT Population included all randomized participants. The Safety Population included all participants who received at least 1 dose of study drug. Two participants in the Pamrevlumab group did not receive study drug and were not included in the Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pamrevlumab | Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
Due to early termination of this study, formal analyses of the primary and secondary endpoints are not presented because the study's sample size is substantially underpowered for meaningful interpretation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Desk | FibroGen, Inc. | 415-978-1346 | jcharpentier@fibrogen.com |
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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 | May 12, 2020 | Apr 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2021 | Apr 27, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C560078 | pamrevlumab |
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Proof-of-concept
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| Placebo | Drug | Sterile liquid for injection |
|
| Time to Recovery as Based on a Modified 8-Point Ordinal Scale | Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen). | Day 28 |
| Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO) | Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28. | up to Day 28 |
| Days on Mechanical Ventilation and/or ECMO | Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28. | up to Day 28 |
| Time to Mechanical Ventilation/ECMO or All-cause Mortality | Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation. | up to Day 28 |
| Number of Participants With All-cause Mortality | up to Day 28 |
| Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables | up to Day 28 |
| Time to Death From Any Cause | Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation. | up to Day 28 |
| Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2 | up to Day 28 |
| Change in (Non-invasive) Oxygen Supplementation Requirements | up to Day 28 |
| Greensboro |
| North Carolina |
| 27403 |
| United States |
| Research Center | Philadelphia | Pennsylvania | 19107 | United States |
| Research Center | Philadelphia | Pennsylvania | 19140 | United States |
| Death |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28 | ITT Population: All randomized participants. | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14 | ITT Population: All randomized participants. | Posted | Count of Participants | Participants | Day 14 |
|
|
|
| Secondary | Time to Recovery as Based on a Modified 8-Point Ordinal Scale | Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen). | ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Day 28 |
|
|
|
| Secondary | Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO) | Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28. | ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | up to Day 28 |
|
|
|
| Secondary | Days on Mechanical Ventilation and/or ECMO | Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28. | ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | up to Day 28 |
|
|
|
| Secondary | Time to Mechanical Ventilation/ECMO or All-cause Mortality | Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation. | ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | up to Day 28 |
|
|
|
| Secondary | Number of Participants With All-cause Mortality | ITT Population: All randomized participants. | Posted | Count of Participants | Participants | up to Day 28 |
|
|
|
| Secondary | Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables | Due to early termination of the study, data was not collected for the assessment. | Posted | up to Day 28 |
|
|
| Secondary | Time to Death From Any Cause | Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation. | ITT Population: All randomized participants. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | up to Day 28 |
|
|
|
| Secondary | Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2 | Due to early termination of the study, data was not collected for the assessment. | Posted | up to Day 28 |
|
|
| Secondary | Change in (Non-invasive) Oxygen Supplementation Requirements | Due to early termination of the study, data was not collected for the assessment. | Posted | up to Day 28 |
|
|
| 3 |
| 11 |
| 5 |
| 9 |
| 4 |
| 9 |
| EG001 | Placebo | Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks | 2 | 11 | 2 | 11 | 8 | 11 |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Adrenal mass | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |