COVID-19 患者の Zofin へのアクセス拡大
SARS-Cov-2 による軽度から中等度の COVID-19 患者の治療のための Zofin へのアクセスを外来および入院患者向けに拡大
調査の概要
詳細な説明
ヒト コロナウイルス (HCoV-19) は、世界中で新しいコロナウイルス病 (COVID-19) の発生を引き起こしています。 COVID-19 の一般的な症状には、発熱、咳、息切れなどがあります。 ほとんどの場合、症状は軽度ですが、肺炎や多臓器不全に進行する場合もあります。 重症度に応じて、軽症、正常、重症、重篤に分類され、ICU への入院と死亡率に関連しています。 現在、COVD-19 患者の標準治療は、酸素療法、人工呼吸器、および血圧を維持するための投薬です。 今日現在、COVID-19 患者に利用できる特定の抗ウイルス療法はありません。 一部の患者における免疫活性化、およびサイトカインストーム症候群 (CSS) の出現は、死に至る可能性がある肺や他の臓器への深刻な損傷の重要な原因の 1 つです。 疾患の経過中に過剰な免疫応答をタイムリーに抑制し、肺胞機能を保護し、肺および全身臓器の損傷を軽減するための新しい介入を開発する緊急の必要性があります。
Zofin は、ヒト羊水 (HAF) に由来する無細胞の最小限に操作された製品です。 この製品には、300 を超える成長因子、サイトカイン、ケモカイン、および羊膜幹細胞および上皮細胞に由来するその他の細胞外小胞/ナノ粒子が含まれています。 この製品には、平均モードサイズが 125.2 nm の平均濃度 5.24x10^11 粒子/mL が含まれています。 表面マーカー分析により、CD133 の高発現に加えて、エキソソーム関連タンパク質 CD63、CD81、および CD9 の存在が確認されました。 完了した配列決定により、102 個の一般的に発現する miRNA が明らかになりました (発現最小値は 100 コピー)。 バイオインフォマティクス分析により、63 個の miRNA が 1216 個の RNA ターゲットに関連付けられました。 炎症誘発性サイトカイン カスケードの主要なプレーヤーは、miRNA の標的となることがわかっており、TNF、IL-6、IL-8 などの Organicell 製品で発見されました。 さらに、FGF2、IFNB1、IGF1、IL36a、IL37、TGF-B2、VEGFA、CCL8、CXCL12 などの miRNA のコレクションは、より広範な炎症誘発性サイトカインも標的としています。 発表された研究では、この炎症誘発性サイトカインカスケードの阻害または抑制が、免疫応答の上昇に関連する症状の重症度を軽減する可能性があることが示唆されています. さらに、miRNA は免疫応答に関連する 148 の遺伝子を標的とすることがわかった。
Zofin の特性は、COVID-19 感染の重症度を軽減するためのサイトカイン活性化の抑制剤としての治療の可能性を示しています。 これは、SARS-Cov-2 による軽度から中等度の COVID-19 の治療に ZofinTM (OrganicellTM Flow) を使用して被験者を治療するための、オープン ラベルの拡張アクセス プロトコルです。
研究の種類
拡張アクセス タイプ
- 治療IND/プロトコル
連絡先と場所
研究連絡先
- 名前:Mari Mitrani, MD, PhD
- 電話番号:888-963-7881
- メール:clinicaltrials@organicell.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
包含基準:
- 書面によるインフォームド コンセントを提供する
- -被験者は、インフォームドコンセントフォームに署名した時点で18歳以上です。
- 男性か女性
- -定性的な逆転写ポリメラーゼ連鎖反応(RT-PCR)によるCOVID-19の臨床診断が必要であり、以下の#5で定義されている軽度または中等度のCOVID-19臨床症状の少なくとも1つを伴う
軽度から中等度の COVID-19 症状のある外来患者および入院患者集団。
軽度の病気の主な症状は次のとおりです。
- 微熱 <38°C (37.5 ~ 37.9)
- 乾いた咳
- 疲れ
- わずかに息苦しさを感じる
- 筋肉痛
- 頭痛
- 喉の痛み
- 下痢
中程度の病気の主な症状は次のとおりです。
軽度の病気で患者が受ける可能性のある症状に加えて、患者は次のような症状も経験する可能性があります。
- 38°以上の発熱
- 1 時間に数回の乾いた、より持続的な咳
- 疲労感と寝たきりの必要性
- 適度な運動(階段を上るなど)をすると息苦しくなる
- 筋肉痛と痛み、ベッドにとどまる必要がある
- 特に暑いと頭痛がする
- のどの痛み、咳の痛みはあるが痛みはない
- 下痢
- 口が渇く
- 適切な静脈アクセス
-出産の可能性のある女性(WOCBP)のみ、治療後6か月までFDAが推奨する避妊を使用する意欲。 避妊のための FDA 承認およびクリアされた方法を以下に示します。
- 永久殺菌
- 長時間作用型可逆避妊薬 (LARC)
- 避妊注射
- 短時間作用型ホルモン法
- バリア法
- 緊急避妊
https://www.fda.gov/consumers/free-publications-women/birth-control
- 男性被験者は、避妊薬を使用し、研究中に精子を提供しないことに同意する必要があります。
- -すべてのプロトコル要件を順守することに同意し、すべての研究訪問を喜んで完了する必要があります
除外基準:
- COVID-19 による中等度から重度の呼吸窮迫症候群の患者
- 妊娠中、授乳中、または出産の可能性があるが、効果的な避妊法を実践していない女性であること。 女性被験者は、IP注入から72時間以内のスクリーニングで血液妊娠検査を受けなければなりません。
- 必要な評価を実行できない。
- 任意の臓器の移植のためのアクティブなリスト (または将来のリスト)。
- しっかりした臓器移植のレシピエントになる。 これには、以前の細胞ベースの治療(登録の12か月以上前)、骨、皮膚、靭帯、腱、または角膜移植は含まれません。 臓器または細胞移植の拒絶反応の既往歴がある。
- -薬物乱用の病歴(マリファナを除く違法な「ストリート」ドラッグ(患者が居住する州で合法的に使用されている場合)、または既存の病状またはアルコール乱用に適切に使用されていない処方薬(˃ 3 か月)、または過去 24 か月以内にアルコールまたは薬物の使用に起因する医学的、職業的、または法的問題が記録されている
- 未治療のHIV感染患者。 ただし、HIVの治療を受けており、HIVウイルス負荷の検査が陰性であるが、抗体の検査が陽性である場合、患者は登録できます。
研究計画
研究はどのように設計されていますか?
協力者と研究者
出版物と役立つリンク
一般刊行物
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COVID19の臨床試験
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Israel Institute for Biological Research (IIBR)完了
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Colgate Palmolive完了
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Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., Ltd積極的、募集していない
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University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital Zürich招待による登録