Atovaquone for Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Analysis
研究概览
简要总结
The purpose of the current study is to accelerate the use of a clinically available therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19 addressing a serious and emergent unmet medical need.
This is a randomized, double-blind study of atovaquone therapy in adult participants hospitalized with COVID-19. Approximately 60 participants who meet all eligibility criteria may be randomized in a 2:1 atovaquone/placebo ratio into one of the following treatment groups:
Treatment Group 1: continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days
Treatment Group 2: continued standard of care therapy together with matching placebo
详细描述
Design of the ATaQ COVID-19 Trial:
The purpose of the current study is to accelerate the use of a clinically available therapeutic already FDA-approved for other indications in the setting of pandemic COVID-19 addressing a serious and emergent unmet medical need. In consideration of the information included in this protocol, the overall risks to participants are outweighed by the potential benefits of atovaquone experimental therapy for the treatment of COVID-19. The benefit-risk balance for this study is considered positive.
Inclusion Criteria:
- Diagnosis of COVID-19 by positive RT-PCR requiring hospitalization within 72 hours
- Age ≥18 years old
- Able to provide informed consent, or (as allowed by IRB), immediate availability of designated legally authorized representative to provide consent by proxy
- Anticipated hospitalization for >48 hours
Exclusion Criteria
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 by positive RT-PCR requiring hospitalization within 72 hours
- •Age ≥18 years old
- •Able to provide informed consent, or (as allowed by IRB), immediate availability of designated legally authorized representative to provide consent by proxy
- •Anticipated hospitalization for >48 hours
排除标准
- •Participation in any other clinical trial with antiviral activity against COVID-19
- •Breastfeeding women
- •Known hypersensitivity to atovaquone or formulation excipient
- •Active treatment with rifampin
- •HIV patients with AIDS requiring treatment for Pneumocystis jirovecii or Toxoplasma gondii
- •Not expected to survive for 72 hours. 7) >14 days from symptom onset
研究组 & 干预措施
standard of care therapy with atovaquone
The first treatment group will receive continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days.
干预措施: Experimental Group (Drug)
standard of care therapy with matching placebo
The second treatment group will receive continued standard of care therapy together with matching placebo.
干预措施: Placebo Group (Drug)
结局指标
主要结局
Primary Analysis
时间窗: Day 1 to Day 10
Between group differences in viral load (Log copy number/ml) using generalized linear mixed-effect models of repeated measures (GLMM), using data from all available samples
次要结局
- Secondary Between Group Differences in Viral Load(baseline to day7)
- Change in Viral Load at Day 10 Stratified by Sex(baseline to day 10)
- Area Under the Curve Copies/ml*Day at Day 7(day 7)
- Percentage With 2 Log Viral Load Drop at Day 3(baseline to day 3)
- Number of Participants With Change in Ordinal Scale ≥2 Points by Day 15.(Day 15)
- Stratifed by Remdesivir(day 10)
研究者
Mamta K. Jain, MD,MPH
Professor of Medicine
University of Texas Southwestern Medical Center