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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002871-12 | EudraCT Number | ||
| 2023-506667-34-00 | EU Trial (CTIS) Number |
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The purpose of the study is to understand the effects and safety of PF-07817883 treatment. The study wants to know how PF-07817883 treatment lowers the level of the virus that causes COVID 19. To understand that samples are collected from adult participants who have the symptoms of COVID 19 but are not hospitalized.
The study is seeking for participants who:
Around 228 participants with a confirmed case of COVID 19 are planned to be taken into the study. Participants will be randomly grouped to receive PF-07817883. Three groups will receive 100, 300, 600mg of PF-07817883 and one of the groups will receive placebo (a pill that doesn't have any medicines) orally every 12 hours for 5 days.
The study is going to last up to 5 weeks. This includes the initial period of selecting participants, participants receiving the medicine or the placebo and then a 4-week follow-up period after giving the participants the last medicine.
The study team will monitor how each participant is doing with the study treatment during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: low dose | Experimental |
| |
| Arm 2: medium dose | Experimental |
| |
| Arm 3: high dose | Experimental |
| |
| Arm 4: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07817883 | Drug | Arm 1: low dose Arm 2: medium dose Arm 3: high dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5 | Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (<=3 versus [vs.] >3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4*log10 copies/milliliter, missing, or not detected. | Baseline (Day 1), Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14 | Change from baseline in SARS-CoV-2 RNA level at Day 3, Day 10 and Day 14 were analyzed using MMRM model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (<=3 vs. >3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4*log10 copies/milliliter, missing, or not detected. |
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Inclusion Criteria:
Participants ≥18 to <65 years of age at the time of the Screening Visit.
Confirmed SARS-CoV-2 infection as determined by RAT in NP specimen collected within 48 hours prior to randomization. Investigator sites will use test kits that are authorized for use in this study and the test result must be available to confirm eligibility.
Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization.
Exclusion Criteria:
Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or Class C, or acute liver failure.
History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
Immunocompromised with ≥1 of the following:
Solid organ (eg, liver, heart, lung or kidney) transplant recipient who is receiving immunosuppressive therapy.
Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or receiving immunosuppressive therapy.
Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome).
Use of at least 1 of the following immune-weakening medications:
iii. Has received corticosteroids equivalent to prednisone ≥20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
iv. Active treatment causing significant immunosuppression, including alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents, TNF blockers, or other highly immunosuppressive drugs such as biologics.
Hematological malignancy (including leukemia, lymphoma and myeloma) or active immunosuppressive treatment for solid tumor.
HIV infection with CD4 cell count <200 mm3 from known medical history within the past 6 months of screening.
known severe renal impairment (eGFR of <30 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula12).
Oxygen saturation of <92% on room air obtained at rest within 24h prior to randomization.
Has received or is expected to receive any other antiviral for the treatment of COVID 19, including remdesivir, PAXLOVID, molnupiravir, mAb treatment (within 30 days or 5 half-lives [whichever is longer] prior to screening) or received convalescent COVID-19 plasma within 12 months.
Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study.
Current or previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
Known prior participation in this trial
Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials | Cullman | Alabama | 35055 | United States | ||
| ClinMed |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41796210 | Derived | Kim JH, Knutson A, Smith J, Guan S, Chen LF, Mortezavi M, Sloan A, Banerjee A, Baniecki ML, Hyde C, Allerton C, Alami NN. Ibuzatrelvir potently reduced viral RNA levels despite a high rate of anti-S seropositivity: a post hoc analysis of serology of the phase 2b study. Sci Rep. 2026 Mar 8;16(1):12594. doi: 10.1038/s41598-026-42989-9. | |
| 39486089 |
| 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 278 participants were screened, of which 37 failed screening and 1 participant was not randomized due to investigational product shortage at site. A total of 240 participants were randomized and assigned to study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07817883 100mg | Participants received PF-07817883, 100 milligrams (mg) orally every 12 hours (q12h) for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| FG001 | PF-07817883 300mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment (Up to 5 Days) |
|
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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 | Apr 14, 2023 | Sep 12, 2024 |
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| Placebo | Drug | Placebo |
|
| Baseline (Day 1), Day 3, Day 10 and Day 14 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations | An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. Participants with an AE record indicating the AE caused permanent discontinuation from the study were reported under discontinuations from study due to TEAEs. Permanent discontinuations from study intervention due to TEAEs included those participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) |
| Number of Participants With Laboratory Test Abnormalities | The following laboratory parameters were assessed according to pre-specified criteria for abnormalities: a) hematology; hemoglobin (gram per deciliter [g/dL]), (less than[<]0.8*lower limit of normal [LLN]), erythrocytes(10^12/Liter [L])(< 0.8*LLN), lymphocytes(10^9/L)(more than[>]1.2*upper limit of normal [ULN]), neutrophils(> 1.2*ULN and < 0.8*LLN), basophils(10^9/L)(> 1.2*ULN) and eosinophils (10^9/L)(> 1.2*ULN). b) clinical chemistry; bilirubin(mg/dL)(> 1.5*ULN), urea nitrogen(mg/dL)(> 1.3*ULN), creatinine(mg/dL)(> 1.3*ULN), potassium(milli equivalence per millilitre [mEq/L], (< 0.9*LLN and > 1.1*ULN), calcium (mg/dL)(< 0.9*LLN), bicarbonate(mEq/L)(< 0.9*LLN and > 1.1*ULN), glucose (mg/dL)(> 1.5*ULN), creatine kinase(units per litre [U/L) (> 2.0* ULN), D-Dimer(nanogram per milliliter[ng/mL]), (>1.5*ULN) and c)urinalysis; bacteria (low power field [LPF]>20). Number of participants with any laboratory abnormalities meeting pre-specified criteria are reported in this outcome measure.](streamdown:incomplete-link) | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). |
| Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities | Vital signs included blood pressure and pulse rate and were assessed with the participant in the supine or seated position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Pre-defined criteria for vital sign abnormalities was as systolic blood pressure (millimeter of mercury [mmHg]): value < 90, change >= 30 increase and change >= 30 decrease, diastolic blood pressure (mmHg): value <50; change >= 20 increase and change >= 20 decrease, pulse rate (beats per minute [bpm]): value < 40 and value > 120. | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). |
| Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities | Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QT interval, and QT interval correct by Frederica formula (QTcF). ECG abnormalities included: PR interval (millisecond [msec]): value >=280, change >40 increase; QT interval aggregate (msec): value > 500), QTcF interval (450 < value =< 480; 480 < value =< 500; value > 500; 30 < change <= 60 increase and change > 60 increase). | From baseline (Day 1) up to Day 10 |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Epic Medical Research - Surprise | Surprise | Arizona | 85378 | United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States |
| Franco Felizarta, Md | Bakersfield | California | 93301 | United States |
| Hope Clinical Research, Inc. | Canoga Park | California | 91303 | United States |
| Velocity Clinical Research, Chula Vista | Chula Vista | California | 91911 | United States |
| Benchmark Research | Colton | California | 92324 | United States |
| Ascada Health PC dba Ascada Research | Fullerton | California | 92835 | United States |
| Long Beach Clinical Trials | Long Beach | California | 90806 | United States |
| Marvel Clinical Research - Santa Ana | Santa Ana | California | 92704 | United States |
| Herco Medical and Research Center Inc | Coral Gables | Florida | 33134 | United States |
| Advance Clinical Research Group | Cutler Bay | Florida | 33157 | United States |
| Proactive Clinical Research,LLC | Fort Lauderdale | Florida | 33308 | United States |
| Qway Research LLC | Hialeah | Florida | 33010 | United States |
| Unlimited Medical Research Group LLC | Hialeah Gardens | Florida | 33018 | United States |
| Angels Clinical Research Institute | Miami | Florida | 33122 | United States |
| South Florida Research Center | Miami | Florida | 33135 | United States |
| USPA Advance Concept Medical Research Group | Miami | Florida | 33143 | United States |
| Bio-Medical Research LLC | Miami | Florida | 33144 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014 | United States |
| DBC Research USA | Pembroke Pines | Florida | 33029 | United States |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | 33705 | United States |
| Javara - Privia Medical Group Georgia - Albany | Albany | Georgia | 31707 | United States |
| Centricity Research Columbus Georgia Multispecialty | Columbus | Georgia | 31904 | United States |
| Centricity Research Columbus Acute Care | Columbus | Georgia | 31909 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Snake River Research | Idaho Falls | Idaho | 83404 | United States |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | United States |
| Excel Clinical Research, LLC | Las Vegas | Nevada | 89109 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| Wellnow Urgent Care and Research | Cincinnati | Ohio | 45215 | United States |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | United States |
| WellNow Urgent Care & Research | Dayton | Ohio | 45424 | United States |
| Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley | Easley | South Carolina | 29640 | United States |
| Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW | Conroe | Texas | 77384 | United States |
| Javara - Privia Medical Group Gulf Coast - Cypress | Cypress | Texas | 77433 | United States |
| DFW Clinical Research | Dallas | Texas | 75234 | United States |
| Proactive Clinical Research LLC | Edinburg | Texas | 78539 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
| Laguna Clinical Research | Laredo | Texas | 78041 | United States |
| Epic Clinical Research | Lewisville | Texas | 75057 | United States |
| BFHC Research, LLC | San Antonio | Texas | 78249 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW | Shenandoah | Texas | 77384 | United States |
| Javara - Privia Medical Group North Texas - Stephenville | Stephenville | Texas | 76401 | United States |
| Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW | The Woodlands | Texas | 77384 | United States |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| Mortezavi M, Sloan A, Singh RSP, Chen LF, Kim JH, Shojaee N, Toussi SS, Prybylski J, Baniecki ML, Bergman A, Banerjee A, Allerton C, Alami NN. Virologic Response and Safety of Ibuzatrelvir, A Novel SARS-CoV-2 Antiviral, in Adults With COVID-19. Clin Infect Dis. 2025 Mar 17;80(3):673-680. doi: 10.1093/cid/ciae529. |
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
| FG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| FG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Follow Up (Up to 4 Weeks) |
|
|
The full analysis set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention Participants were analyzed according to the intervention they were actually randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-07817883 100mg | Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| BG001 | PF-07817883 300mg | Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| BG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| BG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| BG004 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5 | Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (<=3 versus [vs.] >3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4*log10 copies/milliliter, missing, or not detected. | The modified full analysis set (MFAS) included all participants in the full analysis set (FAS) who had SARS-CoV-2 RNA level greater than or equal to (>=) 4*log10 copies/mL at baseline. Participants were analyzed according to the study intervention to which they were randomized. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 80% Confidence Interval | Log10 copies/milliliter | Baseline (Day 1), Day 5 |
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| Secondary | Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14 | Change from baseline in SARS-CoV-2 RNA level at Day 3, Day 10 and Day 14 were analyzed using MMRM model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (<=3 vs. >3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4*log10 copies/milliliter, missing, or not detected. | The MFAS included all participants in the FAS who had SARS-CoV-2 RNA level >= 4*log10 copies/mL at baseline. Participants were analyzed according to the study intervention to which they were randomized. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Posted | Least Squares Mean | 80% Confidence Interval | Log10 copies/milliliter | Baseline (Day 1), Day 3, Day 10 and Day 14 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. | The safety analysis set (SAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. | Posted | Count of Participants | Participants | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations | An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. Participants with an AE record indicating the AE caused permanent discontinuation from the study were reported under discontinuations from study due to TEAEs. Permanent discontinuations from study intervention due to TEAEs included those participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. | The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. | Posted | Count of Participants | Participants | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) |
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| Secondary | Number of Participants With Laboratory Test Abnormalities | The following laboratory parameters were assessed according to pre-specified criteria for abnormalities: a) hematology; hemoglobin (gram per deciliter [g/dL]), (less than[<]0.8*lower limit of normal [LLN]), erythrocytes(10^12/Liter [L])(< 0.8*LLN), lymphocytes(10^9/L)(more than[>]1.2*upper limit of normal [ULN]), neutrophils(> 1.2*ULN and < 0.8*LLN), basophils(10^9/L)(> 1.2*ULN) and eosinophils (10^9/L)(> 1.2*ULN). b) clinical chemistry; bilirubin(mg/dL)(> 1.5*ULN), urea nitrogen(mg/dL)(> 1.3*ULN), creatinine(mg/dL)(> 1.3*ULN), potassium(milli equivalence per millilitre [mEq/L], (< 0.9*LLN and > 1.1*ULN), calcium (mg/dL)(< 0.9*LLN), bicarbonate(mEq/L)(< 0.9*LLN and > 1.1*ULN), glucose (mg/dL)(> 1.5*ULN), creatine kinase(units per litre [U/L) (> 2.0* ULN), D-Dimer(nanogram per milliliter[ng/mL]), (>1.5*ULN) and c)urinalysis; bacteria (low power field [LPF]>20). Number of participants with any laboratory abnormalities meeting pre-specified criteria are reported in this outcome measure.](streamdown:incomplete-link) | The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). |
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| Secondary | Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities | Vital signs included blood pressure and pulse rate and were assessed with the participant in the supine or seated position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Pre-defined criteria for vital sign abnormalities was as systolic blood pressure (millimeter of mercury [mmHg]): value < 90, change >= 30 increase and change >= 30 decrease, diastolic blood pressure (mmHg): value <50; change >= 20 increase and change >= 20 decrease, pulse rate (beats per minute [bpm]): value < 40 and value > 120. | The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). |
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| Secondary | Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities | Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QT interval, and QT interval correct by Frederica formula (QTcF). ECG abnormalities included: PR interval (millisecond [msec]): value >=280, change >40 increase; QT interval aggregate (msec): value > 500), QTcF interval (450 < value =< 480; 480 < value =< 500; value > 500; 30 < change <= 60 increase and change > 60 increase). | The SAS included all participants randomly assigned to study intervention and who have taken at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From baseline (Day 1) up to Day 10 |
|
From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
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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 | PF-07817883 100mg | Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | PF-07817883 300mg | Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. | 0 | 39 | 1 | 39 | 1 | 39 |
| EG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. | 0 | 79 | 0 | 79 | 2 | 79 |
| EG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. | 0 | 79 | 0 | 79 | 4 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | 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 | May 12, 2023 | Sep 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| 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 |
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 |
|
| LS Mean difference |
| -0.802 |
| Standard Error of the Mean |
| 0.3562 |
| 2-Sided |
| 80 |
| -1.260 |
| -0.344 |
| Other |
| Mixed Models Analysis | <.0001 | LS Mean difference | -1.167 | Standard Error of the Mean | 0.2640 | 2-Sided | 80 | -1.506 | -0.827 | Other |
| OG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
|
|
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
| OG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
|
| OG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
|
| OG001 | PF-07817883 300mg | Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
|
| OG002 | PF-07817883 600mg | Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
|
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
| OG003 | Placebo | Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks. |
|
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|---|---|
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| Title | Measurements |
|---|---|
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