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| ID | Type | Description | Link |
|---|---|---|---|
| C5301004 | Other Identifier | Alias Study Number |
Not provided
Not provided
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Lack of enrollment due to evolution of COVID-19 pandemic with reduction in patients at risk for severe disease and growing number of effective alternative therapies
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The purpose of this study is to determine if a CGRP receptor antagonist may potentially blunt the severe inflammatory response at the alveolar level, delaying or reversing the path towards oxygen desaturation, Acute respiratory distress syndrome (ARDS), requirement for supplemental oxygenation, artificial ventilation or death in patients with COVID-19 on supplemental oxygen.
* BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zavegepant | Experimental | Zavegepant (BHV-3500) 10 mg intranasal (IN) dosed every 8 hours (3 times/day) (Q8h) for 14 days |
|
| Placebo | Placebo Comparator | Placebo Q8h for 14 days Subjects dosed every 8 hours; 3 times/day (Q8h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavegepant (BHV-3500) | Drug | 10 mg intranasal (IN) for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 6 Point Ordinal Severity Rating Scale (6POSRS) Score at Day 15 | The 6POSRS score was used to assess severity and ranged from 1 to 6 where: 1= Death; 2= Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, not requiring supplemental oxygen and 6= not hospitalized. A higher score indicated a better outcome. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a 6-Point Severity Rating of 5 or 6, Who Were Alive and Off Supplemental Oxygen at Day 29 | Percentage of participants who were alive and had a 6POSRS rating of 5 (Hospitalized, not requiring supplemental oxygen) or 6 (not hospitalized) and did not use supplemental oxygen at Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had the last on-study 6POSRS rating before Day 29 used. Participants with >= 1 procedure day of supplemental oxygen use before Day 29 for an ongoing procedure were considered failures, i.e., not alive or not off of oxygen at Day 29. 95% confidence interval (CI) was based on exact Clopper and Pearson method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital Research Pharmacy | Washington D.C. | District of Columbia | 20007 | United States | ||
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 47 participants signed the informed consent form and were enrolled in the study, of which 3 participants failed screening and 44 participants were randomized in the study. The study was terminated early because of lack of enrollment due to the evolution of the COVID-19 pandemic, with a reduction of participants at risk for severe disease, and a growing number of effective alternative therapies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zavegepant | Participants were randomized to receive 10 milligrams (mg) of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2022 | Apr 5, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo Q8h for 14 days |
|
| Day 29 |
| Percentage of Participants With a 6-Point Severity Rating of 2 or 3 or Required Initiation of Invasive Mechanical Ventilation, Non-Invasive Ventilation, or a High-Flow Nasal Cannula Through Day 29 | Percentage of participants who had a 6POSRS rating of 2 (Hospitalized, on invasive mechanical ventilation or ECMO) or 3 (Hospitalized, on non-invasive ventilation or high-flow oxygen devices) or >= 1 procedure day of ventilation or high-flow nasal cannula use on study through Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had all available on-study 6POSRS ratings before Day 29 used. 95% CI was based on exact Clopper and Pearson method. | Up to Day 29 |
| Percentage of Participants Admitted Into an Intensive Care Unit (ICU) Through Day 29 | Percentage of participants admitted into an ICU on any day through Day 29 were reported in this outcome measure. 95% CI was based on exact Clopper and Pearson method | Up to Day 29 |
| Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important medical events. Severe AEs were AEs that interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. On-treatment was defined as the time on study drug. | From first dose of study treatment on Day 1 until Day 15 |
| Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities | The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes, lymphocytes (high and low), neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium (high and low), creatine kinase, creatinine, glomerular filtration rate (GFR) estimated Modification of Diet in Renal Disease (MDRD), glucose (high and low), lactate dehydrogenase, potassium (high and low), sodium (high and low), urate, glucose (urine) and protein (urine). Laboratory abnormalities were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 for all parameters except glucose and uric acid. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 was used for grading glucose and uric acid. Grade 3=severe and grade 4=potentially life threatening. Number of participants with grade 3 or 4 laboratory abnormalities is reported. | From first dose of study treatment on Day 1 until Day 15 |
| Number of Participants With Severe or Life-Threatening Bacterial, Invasive Fungal, or Opportunistic Infections Through Day 29 | Number of participants with any severe or life-threatening bacterial, invasive fungal, or opportunistic infections through Day 29 is reported in this outcome measure. Severe= interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Life threatening=Participant was at immediate risk of death from the event as it occurred; i.e., it did not include a reaction that if it had occurred in a more serious form might have caused death. | Up to Day 29 |
| Number of Participants With Intranasal Administration Reactions Through Day 29 | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with this treatment. Number of participants with any adverse events associated with intranasal administration were reported in this outcome measure. | Up to Day 29 |
| Percentage of Participants With >= 50% Reduction in Estimated Glomerular Filtration Rate (eGFR) From Baseline | Percentage of participants with >=50% reduction in eGFR from Baseline during on-treatment phase were reported in this outcome measure. | From Baseline (Day 1) up to Day 15 |
| Georgetown University Hospital |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | United States |
| Roper Hospital | Charleston | South Carolina | 29401 | United States |
| Placebo |
Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zavegepant | Participants were randomized to receive 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60. |
| BG001 | Placebo | Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60. |
| BG002 | 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 | Mean 6 Point Ordinal Severity Rating Scale (6POSRS) Score at Day 15 | The 6POSRS score was used to assess severity and ranged from 1 to 6 where: 1= Death; 2= Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 3= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, not requiring supplemental oxygen and 6= not hospitalized. A higher score indicated a better outcome. | Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Day 15 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a 6-Point Severity Rating of 5 or 6, Who Were Alive and Off Supplemental Oxygen at Day 29 | Percentage of participants who were alive and had a 6POSRS rating of 5 (Hospitalized, not requiring supplemental oxygen) or 6 (not hospitalized) and did not use supplemental oxygen at Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had the last on-study 6POSRS rating before Day 29 used. Participants with >= 1 procedure day of supplemental oxygen use before Day 29 for an ongoing procedure were considered failures, i.e., not alive or not off of oxygen at Day 29. 95% confidence interval (CI) was based on exact Clopper and Pearson method. | Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 29 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a 6-Point Severity Rating of 2 or 3 or Required Initiation of Invasive Mechanical Ventilation, Non-Invasive Ventilation, or a High-Flow Nasal Cannula Through Day 29 | Percentage of participants who had a 6POSRS rating of 2 (Hospitalized, on invasive mechanical ventilation or ECMO) or 3 (Hospitalized, on non-invasive ventilation or high-flow oxygen devices) or >= 1 procedure day of ventilation or high-flow nasal cannula use on study through Day 29 were reported in this outcome measure. Participants with missing 6POSRS rating at Day 29 had all available on-study 6POSRS ratings before Day 29 used. 95% CI was based on exact Clopper and Pearson method. | Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 29 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Admitted Into an Intensive Care Unit (ICU) Through Day 29 | Percentage of participants admitted into an ICU on any day through Day 29 were reported in this outcome measure. 95% CI was based on exact Clopper and Pearson method | Efficacy analysis set included all participants who were randomized only once and received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 29 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With On-Treatment Deaths, Serious Adverse Events (SAEs) and Severe Adverse Events (AEs) | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; other important medical events. Severe AEs were AEs that interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. On-treatment was defined as the time on study drug. | Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo). | Posted | Count of Participants | Participants | From first dose of study treatment on Day 1 until Day 15 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 or 4 On-Treatment Laboratory Test Abnormalities | The following laboratory parameters were assessed: eosinophils, hemoglobin, leukocytes, lymphocytes (high and low), neutrophils, platelets, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, bilirubin, calcium (high and low), creatine kinase, creatinine, glomerular filtration rate (GFR) estimated Modification of Diet in Renal Disease (MDRD), glucose (high and low), lactate dehydrogenase, potassium (high and low), sodium (high and low), urate, glucose (urine) and protein (urine). Laboratory abnormalities were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 for all parameters except glucose and uric acid. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 was used for grading glucose and uric acid. Grade 3=severe and grade 4=potentially life threatening. Number of participants with grade 3 or 4 laboratory abnormalities is reported. | Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo). Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From first dose of study treatment on Day 1 until Day 15 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Severe or Life-Threatening Bacterial, Invasive Fungal, or Opportunistic Infections Through Day 29 | Number of participants with any severe or life-threatening bacterial, invasive fungal, or opportunistic infections through Day 29 is reported in this outcome measure. Severe= interrupted usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. Life threatening=Participant was at immediate risk of death from the event as it occurred; i.e., it did not include a reaction that if it had occurred in a more serious form might have caused death. | Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo). | Posted | Count of Participants | Participants | Up to Day 29 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Intranasal Administration Reactions Through Day 29 | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with this treatment. Number of participants with any adverse events associated with intranasal administration were reported in this outcome measure. | Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo). | Posted | Count of Participants | Participants | Up to Day 29 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 50% Reduction in Estimated Glomerular Filtration Rate (eGFR) From Baseline | Percentage of participants with >=50% reduction in eGFR from Baseline during on-treatment phase were reported in this outcome measure. | Safety analysis set included all participants who received >=1 dose of study drug (zavegapant or placebo). Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | From Baseline (Day 1) up to Day 15 |
|
|
On treatment: From start of study drug on Day 1 up to Day 15 and Follow up: From Day 16 to Day 60
Same event may appear as both an SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
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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 | Zavegepant (On-treatment) | Participants received 10 mg of zavegepant via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. | 1 | 28 | 6 | 28 | 22 | 28 |
| EG001 | Placebo (On-treatment) | Participants received placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. | 1 | 15 | 2 | 15 | 13 | 15 |
| EG002 | Zavegepant (Follow-up) | Participants who received zavegepant during the double-blind treatment phase were followed up from Day 16 to Day 60. | 4 | 27 | 2 | 27 | 4 | 27 |
| EG003 | Placebo (Follow-up) | Participants who received placebo during the double-blind treatment phase were Followed up from Day 16 to Day 60. | 0 | 13 | 1 | 13 | 2 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endotracheal intubation | Surgical and medical procedures | MedDRA 24.0 | Non-systematic Assessment |
| |
| Intensive care | Surgical and medical procedures | MedDRA 24.0 | Non-systematic Assessment |
| |
| Gastrostomy tube removal | Surgical and medical procedures | MedDRA 24.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Intensive care | Surgical and medical procedures | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Cardiac dysfunction | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Scleral oedema | Eye disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Apr 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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 |
|
|
|
|
|
|
|
Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60.
|
|
| OG001 | Placebo | Participants were randomized to receive placebo via the intranasal route every 8 hours (± 2 hours) for approximately 14 days (42 doses) during the double-blind treatment phase. Participants had an end of treatment visit on Day 15. Participants were followed up until Day 60. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|