PF-07817883
DrugArm 1: low dose Arm 2: medium dose Arm 3: high dose
NCT Number: NCT05799495
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.
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Notify Me18 year–64 year
All sexes
Interventional
Phase 2
Cullman Clinical Trials, Cullman, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Arm 1: low dose Arm 2: medium dose Arm 3: high dose
Placebo
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Pfizer
Industry
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE VIROLOGICAL RESPONSE AND SAFETY OF ORAL PF-07817883 IN NON-HOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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