A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
- Registration Number
- NCT05799495
- Lead Sponsor
- Pfizer
- Brief Summary
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:
* are 18 years of age or older at the time of entering the study.
* have a positive rapid antigen test within 48 hours before entering the study. Rapid antigen test is a test done to confirm the presence of a specific virus in the body.
* have onset of signs or symptoms of COVID-19 within 5 days before entering the study.
* have at least 1 of the specified signs or symptoms of COVID-19 present on the day of entering the study.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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Participants ≥18 to <65 years of age at the time of the Screening Visit.
- WOCBP may be enrolled.
- All fertile participants must agree to use a highly effective method of contraception.
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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.
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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.
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Current need for hospitalization or anticipated need for hospitalization within 24h after randomization in the clinical opinion of the site investigator.
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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.
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History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
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Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
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Immunocompromised with ≥1 of the following:
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Solid organ (eg, liver, heart, lung or kidney) transplant recipient who is receiving immunosuppressive therapy.
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Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or receiving immunosuppressive therapy.
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Moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome).
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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.
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Hematological malignancy (including leukemia, lymphoma and myeloma) or active immunosuppressive treatment for solid tumor.
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HIV infection with CD4 cell count <200 mm3 from known medical history within the past 6 months of screening.
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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).
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Oxygen saturation of <92% on room air obtained at rest within 24h prior to randomization.
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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.
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Expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study.
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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.
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Known prior participation in this trial
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Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
- T bili ≥2 × ULN (except for Gilbert's syndrome)
- AST or ALT ≥2.5 × ULN
- Abs neutrophil count <1000/mm3.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: medium dose PF-07817883 - Arm 4: Placebo Placebo - Arm 3: high dose PF-07817883 - Arm 1: low dose PF-07817883 -
- Primary Outcome Measures
Name Time Method 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 Baseline (Day 1), 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14 Baseline (Day 1), Day 3, Day 10 and Day 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations From start of study intervention up to 28 days after last dose of study intervention (up to 33 days) 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.
Number of Participants With Laboratory Test Abnormalities From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). 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.
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities From start of study intervention up to 28 days after last dose of study intervention (up to 33 days). 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.
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities From baseline (Day 1) up to Day 10 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).
Trial Locations
- Locations (51)
Remington-Davis, Inc
🇺🇸Columbus, Ohio, United States
Proactive Clinical Research LLC
🇺🇸Edinburg, Texas, United States
Franco Felizarta, Md
🇺🇸Bakersfield, California, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
ClinMed
🇺🇸Phoenix, Arizona, United States
Epic Medical Research - Surprise
🇺🇸Surprise, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Unlimited Medical Research Group LLC
🇺🇸Hialeah Gardens, Florida, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Velocity Clinical Research, Chula Vista
🇺🇸Chula Vista, California, United States
Benchmark Research
🇺🇸Colton, California, United States
Ascada Health PC dba Ascada Research
🇺🇸Fullerton, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Marvel Clinical Research - Santa Ana
🇺🇸Santa Ana, California, United States
Herco Medical and Research Center Inc
🇺🇸Coral Gables, Florida, United States
Advance Clinical Research Group
🇺🇸Cutler Bay, Florida, United States
Proactive Clinical Research,LLC
🇺🇸Fort Lauderdale, Florida, United States
Qway Research LLC
🇺🇸Hialeah, Florida, United States
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
Angels Clinical Research Institute
🇺🇸Miami, Florida, United States
Bio-Medical Research LLC
🇺🇸Miami, Florida, United States
South Florida Research Center
🇺🇸Miami, Florida, United States
USPA Advance Concept Medical Research Group
🇺🇸Miami, Florida, United States
Coral Research Clinic Corp
🇺🇸Miami, Florida, United States
DBC Research USA
🇺🇸Pembroke Pines, Florida, United States
GCP Research, Global Clinical professionals
🇺🇸Saint Petersburg, Florida, United States
Javara - Privia Medical Group Georgia - Albany
🇺🇸Albany, Georgia, United States
Centricity Research Columbus Georgia Multispecialty
🇺🇸Columbus, Georgia, United States
Centricity Research Columbus Acute Care
🇺🇸Columbus, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Snake River Research
🇺🇸Idaho Falls, Idaho, United States
University of Massachusetts Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Excel Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
Wellnow Urgent Care and Research
🇺🇸Cincinnati, Ohio, United States
WellNow Urgent Care & Research
🇺🇸Dayton, Ohio, United States
Kur Research @ Bon Secours Mercy Health, Inc - Urgent Care Easley
🇺🇸Easley, South Carolina, United States
Javara - Privia Medical Group Gulf Coast - The Woodlands PGTW
🇺🇸The Woodlands, Texas, United States
Javara - Privia Medical Group Gulf Coast - Cypress
🇺🇸Cypress, Texas, United States
DFW Clinical Research
🇺🇸Dallas, Texas, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
Laguna Clinical Research
🇺🇸Laredo, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
BFHC Research, LLC
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Javara - Privia Medical Group North Texas - Stephenville
🇺🇸Stephenville, Texas, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States