COVID: PAXLOVID - klinická studie, výběr

In July 2021, Pfizer initiated the first of these trials, known as EPIC-HR, a randomized, double-blind study of non-hospitalized adults with COVID-19, who are at high risk of progressing to severe illness. At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. FDA, Pfizer ceased further enrollment into the study in early November 2021 due to the overwhelming efficacy demonstrated in these results. Data have been submitted to the FDA as part of its submission for Emergency Use Authorization, and findings from the EPIC-HR interim analysis have been submitted to a peer-reviewed journal for publication.

In August 2021, Pfizer began the Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), to evaluate efficacy and safety in adults with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., low risk of hospitalization or death). EPIC-SR includes a cohort of vaccinated adults who have an acute breakthrough symptomatic COVID-19 infection and who have risk factors for severe illness. Interim data from this study have been reported. In September, Pfizer initiated the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member.

These trials are ongoing, some data of study:

Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

Brief Summary: The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

No Study Results Posted on ClinicalTrials.gov for this Study

Criteria

Inclusion Criteria:

• Confirmed SARS-CoV-2 infection 5 days prior to randomization
• Initial onset of COVID-19 signs/symptoms within 5 days of randomization
• Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

• Has received or is expected to receive any COVID-19 vaccine, except for participants with an underlying medical condition associated with an increased risk of developing severe illness from COVID-19. Participants with these conditions who are fully vaccinated are considered to be at lower risk of developing severe disease and are therefore considered eligible.
• History of or need for hospitalization for the medical treatment of COVID-19.
• Prior diagnosis of SARS-CoV-2 infection (reinfection)
• Known medical history of liver disease
• Receiving dialysis or have known renal impairment
• Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
• Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
• Is expected to receive a SARS-CoV-2 vaccine between screening and the study Day 34 visit
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
• Known prior participation in this trial or other trial involving PF-07321332
• Oxygen saturation of < 92% on room air
• Females who are pregnant or breastfeeding

čerpáno: clinicaltrials.gov, https://www.pfizer.com/news/press-release/press-release-detail/ema-issues-advice-potential-early-use-pfizers-novel-covid