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

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.

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.

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TEAEs included those participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.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 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.

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.

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).