JPRN-jRCT2031200035已完成3 期
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Adaptive COVID-19 Treatment Trial (ACTT-2)
Ohmagari Norio0 个研究点目标入组 1,033 人开始时间: 2020年5月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,033
研究概览
简要总结
Combination treatment with the antiinflammatory drug baricitinib and the antiviral drug remdesivir was superior to remdesivir alone for the treatment of hospitalized patients with Covid-19 pneumonia. The beneficial effects of the combination treatment were seen both in the primary outcome, with a shorter time to recovery, and in the key secondary outcome, with a greater improvement in clinical status as assessed on the ordinal scale. The combination was associated with fewer serious adverse events.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Admitted to a hospital with symptoms suggestive of COVID-19 infection.
- •2.Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- •3.Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- •4.Male or non-pregnant female adult =>18 years of age at time of enrollment.
- •5.Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen, as documented by either of the following
- •-PCR positive in sample collected < 72 hours prior to randomization OR
- •-PCR positive in sample collected => 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.). AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •6.Illness of any duration, and at least one of the following
- •-Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- •-SpO2 <= 94% on room air, OR
- •-Requiring supplemental oxygen, OR
- •-Requiring mechanical ventilation.
- •7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
- •8.Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.
排除标准
- •1. ALT or AST > 5 times the upper limit of normal.
- •2. Estimated glomerular filtration rate (eGFR) < 30 ml/min or patient is receiving hemodialysis or hemofiltration at time of screening.
- •3. Neutropenia (absolute neutrophil count <1000 cells/microL) (<1.0 x 103/microL or <1.0 GI/L).
- •4. Lymphopenia (absolute lymphocyte count <200 cells/microL) (<0.20 x 103/microL or <0.20 GI/L)
- •5. Pregnancy or breast feeding.
- •6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
- •7. Allergy to any study medication.
- •8. Received three or more doses of remdesivir, including the loading dose, outside of the study under the EUA (or similar mechanism) for COVID-19.
- •9. Received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19, the current illness for which they are being enrolled.
- •10. Received small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatibib, genfinitib), in the 1 week prior to screening
- •11. Received monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
- •12. Received monoclonal antibodies targeting B-cell (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
- •13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger than the risk of COVID-19.
- •14. Received =>20 mg/day of prednisone or equivalent for =>14 consecutive days in the 4 weeks prior to screening.
- •15. Use of probenecid that cannot be discontinued at study enrollment.
- •16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
- •17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
- •18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
- •19. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE).
- •20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.
研究者
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