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呼吸道感染的策略和治疗 & 病毒紧急情况(STRIVE):免疫调节策略试验
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简短的总结
COVID-19可引发失调的免疫反应, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). 对于两组人来说, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement.
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入选标准:
- Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests in the PIM] within 14 days of randomization.
- 需要住院治疗COVID-19
- Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen ≤2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen > 2 l和 &10l低流量氧气.
- Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization.
- Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met.
- 调查员同意肺炎是由COVID-19引起的.
排除标准:
- Oxygen requirement of ≥10L or more of low flow oxygen (or equivalent if using Venturi mask, 等), 或者需要HFNO, 新和合本, IMV, 或医学界.
- Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (例子: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.)
* Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator.
- 对研究药物过敏.
- Neutropenia (absolute neutrophil count <1000 cells/μL) (<1.0 x 10 3 /μL or <1.0 G/L)在最近的实验室随机2天内.
- Lymphopenia (absolute lymphocyte count <200 cells/μL) (<0.20 x 10 3 /μL or <0.20 G/L)在最近的实验室随机2天内.
- 已知或怀疑活跃或最近严重感染(细菌感染), 真菌, 病毒, 或者寄生虫感染, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation.
- 已知或怀疑有未经治疗的结核病史. TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. 如果参与者事先知道，他们也被排除在外, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, 无需筛选).
- Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, 包括任何COVID-19疫苗.
- Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1天.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen)
- Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (<1.0 × 10 9个细胞/µL)或淋巴细胞减少(<1.0 × 10 9 cells/µL
- 参与者患有未经治疗的晚期艾滋病毒(已知CD4) <200 in the past 6 months) AND is not established on antiretro病毒 therapy
- 怀孕
- 母乳喂养
- Co-enrollment in other trials not predetermined to be compatible with this trial.
- 在调查员的判断中, the patient has any advanced organ dysfunction that would not make participation appropriate.
- The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient.
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