PER-095-20已完成未知
A RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF MONOCLONAL ANTIBODY VIR-7831 FOR THE EARLY TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED PATIENTS
Vir Biotechnology, Inc.,0 个研究点目标入组 1 人开始时间: 2020年12月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participant must be aged 18 years or older AND at high risk of progression of
- •COVID-19 based on presence of one or more of the following risk factors:
- •diabetes (requiring medication), obesity (BMI>30), chronic kidney disease
- •(i.e., eGFR <60 by MDRD), congestive heart failure (NYHA class II or more),
- •chronic obstructive pulmonary disease (history of chronic bronchitis, chronic
- •obstructive lung disease, or emphysema with dyspnea on physical exertion), and
- •moderate to severe asthma (participant requires an inhaled steroid to control
- •symptoms or has been prescribed a course of oral steroids in the past year)
- •2. Participant ≥ 55 years old, irrespective of co-morbidities.
- •3. Participants who have a positive SARS-CoV-2 test result (by any validated test
- •e.g. RT-PCR on any specimen type)
- •Oxygen saturation ≥94% on room air
- •Have COVID-19 defined by one or more of the following symptoms: fever, chills,
- •cough, sore throat, malaise, headache, joint or muscle pain, change in smell or
- •taste, vomiting, diarrhea, shortness of breath on exertion
- •Less than or equal to 5 days from onset of symptoms.
- •4. No gender restrictions
- •5. Female participants must meet and agree to abide by the following contraceptive
- •criteria. Contraception use by women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and one of the following conditions applies:
- •a. Is a woman of non-childbearing potential (WONCBP) as defined in
- •Section 10.4.
- •b. Is a WOCBP and using a contraceptive method that is highly effective, with a
- •failure rate of <1%, as described in Section 10.4 of the protocol during the
- •study intervention period and for up to 24 weeks after the last dose of study
- •intervention. The investigator should evaluate potential for contraceptive
- •method failure (e.g., noncompliance, recently initiated) in relationship to the
- •first dose of study intervention.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum
- •as required by local regulations) before the first dose of study intervention.
- •See Section 8.3.7 Pregnancy Testing of the protocol.
- •− If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a
- •serum pregnancy test is required. In such cases, the participant must be excluded
- •from participation if the serum pregnancy result is positive.
- •− Additional requirements for pregnancy testing during and after study intervention
- •are located in Section 1.3 of the protocol.
- •The investigator is responsible for review of medical history, menstrual history, and
- •recent sexual activity to decrease the risk for inclusion of a woman with an early
- •undetected pregnancy.
- •6. Capable of giving signed informed consent as described in Section 10.1 which
- •includes compliance with the requirements and restrictions listed in the informed
- •consent form (ICF) and in this protocol.
- •If participants are not capable of giving written informed consent, alternative
- •consent procedures will be followed as described in Section 10.1.3.
排除标准
- •1. Currently hospitalized or judged by the investigator as likely to require
- •hospitalization in the next 24 hours
- •2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at
- •rest or respiratory distress or requiring supplemental oxygen.
- •3. Participants who, in the judgement of the investigator are likely to die in the next
- •4. Severely immunocompromised participants including but not limited to cancer
- •patients receiving immunosuppressive chemotherapy or immunotherapy, those
- •with a solid organ transplant or allogeneic stem cell transplant within the last
- •3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to ≥ 20mg a day of prednisone or the systemic equivalent for over 2 weeks)
- •5. Known hypersensitivity to any constituent present in the investigational product
- •6. Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
- •7. Enrollment in any investigational vaccine study within the last 180 days or any
- •other investigational drug study within 30 days prior to Day 1 or within
- •5 half-lives of the investigational compound, whichever is longer.
- •8. Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
- •9. Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not
- •be allowed for 4 weeks after dosing.
- •10. Receipt of convalescent plasma from a recovered COVID-19 patient or
- •anti-SARS-CoV-2 mAb within the last 3 months.
- •11. Participants who, in the judgment of the investigator, will be unlikely or unable to
- •comply with the requirements of the protocol through Day 29.
研究者
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