ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,214
- 试验地点
- 109
- 主要终点
- Time to Sustained Recovery in Days
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. Participants will self-report any new or worsening symptoms or medical events experienced while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to be seen in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
详细描述
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.
This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.
Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.
Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.
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, Care Provider)
盲法说明
The participant and study teams will know which study drug the participant is allocated to, but will be blinded to study drug versus placebo.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Informed Consent
- •Age ≥ 30 years old
- •Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
- •Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
排除标准
- •Current or recent (within 10 days of screening) hospitalization for COVID-19 infection
- •Current or planned participation in another interventional trial to treat COVID-19, at the discretion of the study principal investigator (PI)
- •Current or recent use (within the last 14 days) of study drug or study drug/device combination
- •Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
- •Known contraindication(s) to study drug including prohibited concomitant medications
- •Previous or current enrollment in the ACTIV-6 trial
研究组 & 干预措施
Arm G - Metformin
Metformin IR tablets will be self-administered orally according to the following dosing schedule:
- 500 mg on Day 1;
- 500 mg in the morning and 500 mg in the evening on Day 2 through Day 5; and
- 500 mg in the morning and 2 x 500 mg (a total of 1000 mg) in the evening on Day 6 through Day 14.
干预措施: Metformin (Drug)
Arm G - Placebo
Placebo - appearance and size matched to active study drug.
Placebo will be self-administered orally by each participant, with number of tablets matched to active study drug dosing.
干预措施: Placebo (Other)
结局指标
主要结局
Time to Sustained Recovery in Days
时间窗: Up to 28 days
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Number of Participants With Hospitalization or Death
时间窗: Up to 28 days
次要结局
- Number of Participants With Mortality(Up to 28 days)
- Time to Mortality(Up to 28 days)
- Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death(Up to 28 days)
- Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7(Day 7)
- Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14(Day 14)
- Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28(Day 28)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Pain(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Depression(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Social(Day 7, 14, 28, 90, 120, and 180)
- Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep(Day 7, 14, 28, 90, 120, and 180)
- Time Unwell in Days as Measured by the Symptom and Clinical Event Scale(Up to 14 days)
- Mean Days Benefit as Measured by the Symptom and Clinical Event Scale(Up to 14 days)
研究者
Susanna Naggie, MD
Associate Professor of Medicine
Duke University