重症化リスクの低い症候性の成人COVID-19 外来患者を対象にPF-07321332／リトナビル経口投与の有効性および安全性をプラセボと比較検討する第2/3 相，二重盲検，2 群比較，介入試験（治験実施計画書番号：C4671002）

試験ID jRCT2031210274

最終情報更新日：2024年11月23日

基本情報

• 試験ID: jRCT2031210274
• 研究名称 / Scientific Title（Acronym）: 重症化リスクの低い症候性の成人COVID-19 外来患者を対象にPF-07321332／リトナビル経口投与の有効性および安全性をプラセボと比較検討する第2/3 相，二重盲検，2 群比較，介入試験（治験実施計画書番号：C4671002）
• 研究名称 / Scientific Title（Acronym）: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS
• 平易な研究名称 / Public Title（Acronym）: Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
• 試験進捗状況/Recruitment status: 参加者募集中断
• 試験進捗状況/Recruitment status: Complete
• 登録日時: 2021年8月26日
• 最終情報更新日: 2024年11月23日
• 他の臨床研究登録機関発行の研究番号: NCT05011513

試験概要

• 試験実施地域 / Region: 日本
• 試験実施地域 / Region: Argentina,Japan,Brazil,Japan,Bulgaria,Japan,Colombia,Japan,Czech Republic,Japan,Hungary,Japan,India,Japan,Korea,Japan,Malaysia,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Russian Federation,Japan,South Africa,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,Ukraine,Japan,United States,Japan,Puerto Rico,Japan
• 実施都道府県: 東京都
• 目標症例数/Target sample size: 1980
• 対象疾患 / Health condition(s) or Problem(s) studied: COVID-19
• 対象疾患 / Health condition(s) or Problem(s) studied: COVID-19
• 試験のタイプ / Study type: 介入
• 試験のタイプ / Study type: Interventional

介入1

・PF-07321332（錠剤）／リトナビル（カプセル）
・プラセボ（錠剤およびカプセル）

• 介入2: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入3: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入4: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入5: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入6: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入7: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入8: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入9: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）
• 介入10: PF-07321332（錠剤）／リトナビル（カプセル）またはプラセボ（錠剤およびカプセル）を12時間ごとに5日間服用（合計10回）

主要評価項目 / Primary outcomes

評価対象とするすべてのCOVID-19 の徴候または症状の持続的な緩和が得られるまでの期間（日数）（第1日から第28日まで）
COVID-19の症状発現から1-3日の参加者を対象とする。

主要評価項目 / Primary outcomes

Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
Analysis set includes COVID-19 symptom onset 1-3 days before treatment.

副次評価項目 / Secondary outcomes

* Percentage of Participants Who Experience Adverse Events (AEs) [ Time Frame: Baseline through Day 34 ]
* Percentage of Participants Who Experience an AE(s) or Serious Adverse Events (SAEs) that Leads to Study Discontinuation [ Time Frame: Baseline through Day 34 ]
* Proportion of Participants With Severe Signs/Symptoms Attributed to COVID-19 [ Time Frame: Baseline through Day 28 ]
* Time to Sustained Resolution of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
* Duration of Each Targeted COVID-19 Sign/Symptom [ Time Frame: Baseline through Day 28 ]
* Proportion of Participants Progressing to a Worsening Status In 1 or More COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
* Proportion of Participants With a Resting Peripheral Oxygen Saturation >=95% [ Time Frame: Days 1, 5 ]
* Number of COVID-19 Related Medical Visits [ Time Frame: Baseline through Day 28 ]
* Number of Days in Hospital and Intensive Care Unit (ICU) Stay in Participants With COVID-19 Related Hospitalization [ Time Frame: Baseline through Day 28 ]
* Proportion of Participants With COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 28 ]
* Proportion of Participants With Death (all cause) [ Time Frame: Baseline through Week 24 ]
* Minimal Concentration (Ctrough) of PF-07321332 [ Time Frame: Baseline through Day 5 ]
* Viral Titers Measured Via Reverse Transcription Polymerase Chain Reaction (RT-PCR) in Nasal Swabs [ Time Frame: Baseline through Day 14 ]
* Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
Analysis set includes COVID-19 symptom onset 1-5 days before treatment.

適格性

• 年齢（下限）/ Age minimum: 18歳以上
• 年齢（下限）/ Age minimum: >= 18age old
• 年齢（上限）/ Age maximum: Not applicable
• 性別 / Gender: 男女両方
• 性別 / Gender: Both

選択基準 / Include 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

除外基準 / Exclude criteria

*Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
*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
*Has received any SARS-CoV-2 vaccine within 12 months of screening.
*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

責任研究者

• 責任研究者 / Name of lead principal investigator: Norisuke Kawai
• 部署名 / Division: Pfizer R&amp;D Japan G.K.
• 住所 / Address: Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
• 電話 / Telephone: [phone]
• 実施責任組織 / Affiliation: 河合 統介
• 実施責任組織 / Affiliation: Pfizer R&amp;D Japan G.K.

試験問い合わせ窓口

• 住所 / Address: Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo Tokyo Japan 151-8589
• 電話 / Telephone: [phone]
• E-mail: [e-mail]
• 担当者 / Name of contact person: Clinical Trials Information Desk