NCT04346628已完成2 期
A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
研究概览
简要总结
The objective of this study is to evaluate the efficacy of oral favipiravir plus standard of care treatment (SOC) compared with placebo plus SOC in reducing the duration of shedding of SARS-CoV2 virus in patients with mild or asymptomatic COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COVID-19 disease:
- •If symptomatic, presence of mild to moderate symptoms without signs of respiratory distress, with positive for SARS-CoV-2 diagnostic assay within 72 hours prior to.informed consent.
- •If asymptomatic, initial diagnosis obtained no more than 72 hours prior to informed consent
- •Subject agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
- •Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met
- •Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- •Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
- •Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
- •Females must have a negative pregnancy test at screening
- •Participant agrees to maintain home or other quarantine as recommended by the study physician, except to visit the study site as required by the protocol
排除标准
- •Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding).
- •History of abnormal uric acid metabolism.
- •History of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase.
- •Abnormal laboratory test results at screening:
- •Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-
- •Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
- •Previously received favipiravir within the past 30 days.
- •Advanced kidney disease
- •Advanced liver disease
- •History of alcohol or drug abuse in the previous two years.
- •Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
- •Taken another investigational drug within the past 30 days.
- •Seemed by the Investigator to be ineligible for any reason.
研究组 & 干预措施
Favipiravir
Experimental
In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.
干预措施: Favipiravir (Drug)
Favipiravir
Experimental
In addition to SOC, participants will receive favipiravir for 10 days, and be evaluated for health outcomes through day 28.
干预措施: Standard of care treatment (Other)
Placebo
Active Comparator
In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.
干预措施: Placebo (Drug)
Placebo
Active Comparator
In addition to SOC, participants will receive placebo to match favipiravir for 10 days, and be evaluated for health outcomes through day 28.
干预措施: Standard of care treatment (Other)
结局指标
主要结局
Time Until Cessation of Oral Shedding of SARS-CoV-2 Virus
时间窗: Up to 28 days
Time in days from randomization to the first two negative results of nasal and/or oropharyngeal swab.
次要结局
- Sars-CoV-2 Viral Load(Up to 28 days)
- Count of Participants With Clinical Worsening of COVID-19 Disease(Up to 28 days)
- Count of Participants With Development of SARS-CoV-2 Antibodies(Up to 28 days)
- Time Until Cessation of Symptoms(Up to 28 days)
- Count of Participant With Absence of Development of Any Symptoms(Up to 28 days)
- Cmax of Favipiravir(Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration))
- Cmin of Favipiravir(Days 1 and 10 (samples taken 30 minutes prior to and 1 hour following favipiravir administration))
研究者
研究点 (1)
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