コロナ治療薬カトレラ（HIV薬）の有効性否定：NEJM

カトレラ（HIV薬）はコロナ疫の最初期から有効性が期待され、現今治療の標準薬（？）となっている薬剤のようだ。

そのカトレラだが、残念ながら（重症患者における）有効性を否定する報告が中国から出た。対象者は199名で半数に分けられコントロール研究された。エンドポイントは臨床症状の改善（7種類の評価項目）あるいは退院である。

A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

List of authors.

• Bin Cao, M.D., 
• Yeming Wang, M.D., 
• Danning Wen, M.D., 
• Wen Liu, M.S., 
• Jingli Wang, M.D., 
• Guohui Fan, M.S., 
• Lianguo Ruan, M.D., 
• Bin Song, M.D., 
• Yanping Cai, M.D., 
• Ming Wei, M.D., 
• Xingwang Li, M.D., 
• Jiaan Xia, M.D., 

March 18, 2020

Abstract

BACKGROUND

No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.

METHODS

We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir–ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.

RESULTS

A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir–ritonavir group, and 100 to the standard-care group. Treatment with lopinavir–ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72). Mortality at 28 days was similar in the lopinavir–ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, −5.8 percentage points; 95% CI, −17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir–ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir–ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir–ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.

CONCLUSIONS

In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308. opens in new tab.)

ということで

1. 最近中国で有効性が示されたアビガンには期待したい。
2. クロロキンは国内でカトレラ無効例に対する有効性が報告されている。
   　　たとえば「この論文」・・・
3. オルベスコは普通の喘息薬であるが、国内ではすでに処方制限がかけられている。
4. フサン（カモスタット）にも期待したいが、点滴であることがややこしい。
5. 経口薬のあるフォイパンも効くということだが、その効果はフサンの10分の一らしい。