目的：本單一中心病歷回溯研究以nirmatrelvir / ritonavir 及molnupiravir 做對照，評估使用臺灣清冠一號 (NRICM101) 治療感染COVID-19 Omicron 變異株之輕中症，且年紀 ≥ 65 歲或至少具有一個重症風險因子病人的療效。

方法：納入2022 年5 月1 日至2022 年12 月31 日間確診COVID-19 並符合本研究納入條件之門急診病人， 分為NRICM101、nirmatrelvir / ritonavir 及molnupiravir 三組， 以治療權重倒數機率法進行平衡三組的各項特徵。主要結果為疾病進展複合結果：包含COVID-19 確診後30 天內之COVID-19 相關住院（定義為住COVID-19 專責病房並且使用抗COVID-19 重症藥物），及全因性死亡；次要結果為主要結果中單一項目的結果及COVID-19 相關住加護病房。排除COVID-19 診斷兩日內及服藥小於兩日就發生符合研究疾病惡化定義之病人。

結果：NRICM101 組、nirmatrelvir / ritonavir 組及molnupiravir 組分別納入161 人、764 人及1,277 人。一、主要結果：NRICM101 組無論與nirmatrelvir / ritonavir 組 (aHR, 1.220; 95% CI, 0.478–3.116; p = 0.6774) 或molnupiravir 組 (aHR, 1.131; 95% CI, 0.463–2.764; p = 0.7864) 相比，皆未達統計意義。二、次要結果：NRICM101 組相對nirmatrelvir / ritonavir 組(aHR, 7.746; 95% CI, 1.858 –32.288; p = 0.0049)， 及molnupiravir 組 (aHR, 4.972; 95% CI, 1.231 –20.075; p = 0.0243)，皆有較高的COVID-19 相關住院風險。然而，對照nirmatrelvir / ritonavir 組及molnupiravir 組皆有住加護病房及死亡之案例，NRICM101 組住院個案皆為住非加護病房，無住加護病房或死亡案例發生。

結論：本研究觀察到以NRICM101 治療具有重症因子之輕中症COVID-19 病人，相對於nirmatrelvir / ritonavir 或molnupiravir 有較高的COVID-19 相關住院風險，但無住加護病房及死亡案例。此研究結果仍需更多大型的前瞻性研究來證明。

 

Objective: This single-center retrospective medical record review aimed to evaluate the treatment effectiveness of NRICM101 as compared to nirmatrelvir/ritonavir and molnupiravir in patients with mild-to-moderate COVID-19 (Omicron variant), aged ≥ 65 or with other risk factors for disease progression. 

Methods: Patients having visited the outpatient and emergency departments at our institution between May 1, 2022 and December 31, 2022 and met the inclusion criteria were enrolled in the study. The enrolled patients were divided into three groups according to treatment received: NRICM101; nirmatrelvir/ritonavir; and molnupiravir. The primary outcome was a composite of COVID-19-related hospitalization, defined as admitted to the quarantine ward with requirement of medication for severe COVID-19, and all-cause death within 30 days of COVID-19 diagnosis. Secondary outcomes were COVID-19-related hospitalization, COVID-19-related intensive care unit (ICU) admission, and all-cause death. Patients whose study outcomes occurred ≤ 2 days after COVID-19 diagnosis or < 2 days after oral antiviral prescription were excluded. 

Results: This study enrolled 161, 764, and 1,277 patients having received NRICM101, nirmatrelvir/ritonavir, and molnupiravir, respectively. For the primary outcome, there was no statistical difference between the NRICM101 group and the nirmatrelvir/ritonavir group (adjusted hazard ratio [aHR], 1.220; 95%CI, 0.478–3.116; p = 0.6774), or molnupiravir group (aHR, 1.131; 95%CI, 0.463–2.764; p = 0.7864). In terms of secondary outcomes, the NRICM101 group was associated with a higher risk of COVID-19-related hospitalization compared to the nirmatrelvir / ritonavir (aHR, 7.746; 95%CI, 1.858 –32.288; p = 0.0049) and molnupiravir groups (aHR, 4.972; 95%CI, 1.231 –20.075; p = 0.0243). However, while cases of ICU admission and death were noted in the nirmatrelvir / ritonavir and molnupiravir groups, none occurred in the NRICM101 group. 

Conclusion: The NRICM101 group had a higher risk of COVID-19-related hospitalization as compared to the nirmatrelvir/ritonavir and molnupiravir groups, although no cases of ICU admission or death were noted. Further largescale prospective studies are warranted in the future.

 

 

Submitted for publication: 2023.08.10; Accepted for publication: 2023.11.12