NCT04459702撤回2 期
A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection
ProgenaBiome1 个研究点 分布在 1 个国家开始时间: 2020年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Efficacy of Treatment by Time to Non-Infectivity
研究概览
简要总结
This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
详细描述
In this study, patients will be administered either dual or quadruple therapy and have PCR tests run daily to determine efficacy as indicated by time to non-infectivity
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- •Healthy, ambulant male or female subjects 18 years of age to 65 years of age
- •Positive test for COVID-19 by RT-PCR at screening
- •Subjects must agree to practice at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
- •Subjects must agree they will do their best to attend the treatment facility daily for 10 days
排除标准
- •Refusal to sign informed consent form
- •Negative test for COVID-19 by RT-PCR at screening
- •Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 38 degrees; pleuritic pain, or frequent cough.
- •Known drug allergy to any of the investigational medications
- •Currently taking medication with known drug interactions with investigational medications (listed in appendix)
- •Prescription or other antiviral medications
- •Any comorbidities which constitute health risk for the subject
- •Pregnant or lactating females;
- •weight < 110lb;
- •established retinal disease
- •Inability to attend daily for 10 days
- •Any contraindications for treatment with hydroxychloroquine
- •Hypoglycemia
- •Known G6PD deficiency
- •Neutropenia
- •Myasthenia gravis
- •Skeletal muscle disorders
- •Maculopathy
- •Changes in visual field
- •Liver disease
- •History of QT >500msec
- •History of torsades de pointes
- •Anemia from pyruvate kinase and G6PD deficiencies
- •Abnormal EKG with QT prolongation acquired or from birth
- •History of jaundice or high fevers prior to developing COVID-19
- •Treatment with any of the medications listed in Appendix II
- •Treatment with any anti-epileptic medication
- •Treatment with any other drug not listed that affects the QT interval
研究组 & 干预措施
Dual Therapy
Experimental
Dual Therapy utilizing hydroxychloroquine and azithromycin.
干预措施: hydroxychloroquine (Drug)
Dual Therapy
Experimental
Dual Therapy utilizing hydroxychloroquine and azithromycin.
干预措施: Azithromycin (Drug)
Quadruple Therapy
Experimental
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
干预措施: hydroxychloroquine (Drug)
Quadruple Therapy
Experimental
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
干预措施: Azithromycin (Drug)
Quadruple Therapy
Experimental
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
干预措施: Ritonavir (Drug)
Quadruple Therapy
Experimental
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
干预措施: Lopinavir (Drug)
结局指标
主要结局
Efficacy of Treatment by Time to Non-Infectivity
时间窗: 10 days
Time to non-infectivity as measured by PCR testing
Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores
时间窗: 6 months
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
次要结局
- Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN(6 months)
- Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - AST(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel -Albumin(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - BUN(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin(6 months)
- Safety of Dual Therapy as Measured by Treatment Related SAE(6 months)
- Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores(6 months)
- Safety of Dual Therapy as Measured by Complete Blood Count(6 months)
- Safety of Quadruple Therapy as Measured by Complete Blood Count(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - AST(6 months)
- Safety of Quadruple Therapy as Measured by Treatment Related SAE(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Calcium(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel ALT(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Chloride(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Globulin(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Glucose(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine(6 months)
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Potassium(6 months)
- Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Trial of Combination Therapy to Treat COVID-19 InfectionCOVIDCovid-19Corona Virus InfectionCoronavirus-19SARS-CoV2SARS-CoV InfectionCoronavirus InfectionNCT04482686ProgenaBiome31
进行中（未招募）
2 期
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic AgentsFallopian Tube Mucinous AdenocarcinomaOvarian Seromucinous CarcinomaPlatinum-Refractory Fallopian Tube CarcinomaPlatinum-Refractory Ovarian CarcinomaPlatinum-Refractory Primary Peritoneal CarcinomaRecurrent Fallopian Tube Clear Cell AdenocarcinomaRecurrent Fallopian Tube Endometrioid AdenocarcinomaRecurrent Fallopian Tube High Grade Serous AdenocarcinomaRecurrent Fallopian Tube Mucinous AdenocarcinomaRecurrent Fallopian Tube Transitional Cell CarcinomaRecurrent Fallopian Tube Undifferentiated CarcinomaRecurrent Low Grade Fallopian Tube Serous AdenocarcinomaRecurrent Ovarian Clear Cell AdenocarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Ovarian High Grade Serous AdenocarcinomaRecurrent Ovarian Low Grade Serous AdenocarcinomaRecurrent Ovarian Mucinous AdenocarcinomaRecurrent Ovarian Seromucinous CarcinomaRecurrent Ovarian Transitional Cell CarcinomaRecurrent Ovarian Undifferentiated CarcinomaRecurrent Platinum-Resistant Fallopian Tube CarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Platinum-Resistant Primary Peritoneal CarcinomaRecurrent Primary Peritoneal Clear Cell AdenocarcinomaRecurrent Primary Peritoneal Endometrioid AdenocarcinomaRecurrent Primary Peritoneal High Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Low Grade Serous AdenocarcinomaRecurrent Primary Peritoneal Transitional Cell CarcinomaRecurrent Primary Peritoneal Undifferentiated CarcinomaRefractory Fallopian Tube Clear Cell AdenocarcinomaRefractory Fallopian Tube Endometrioid AdenocarcinomaRefractory Fallopian Tube High Grade Serous AdenocarcinomaRefractory Fallopian Tube Mucinous AdenocarcinomaRefractory Fallopian Tube Transitional Cell CarcinomaRefractory Fallopian Tube Undifferentiated CarcinomaRefractory Low Grade Fallopian Tube Serous AdenocarcinomaRefractory Ovarian Clear Cell AdenocarcinomaRefractory Ovarian Endometrioid AdenocarcinomaRefractory Ovarian High Grade Serous AdenocarcinomaRefractory Ovarian Low Grade Serous AdenocarcinomaRefractory Ovarian Mucinous AdenocarcinomaRefractory Ovarian Seromucinous CarcinomaRefractory Ovarian Transitional Cell CarcinomaRefractory Ovarian Undifferentiated CarcinomaRefractory Primary Peritoneal Clear Cell AdenocarcinomaRefractory Primary Peritoneal Endometrioid AdenocarcinomaRefractory Primary Peritoneal High Grade Serous AdenocarcinomaRefractory Primary Peritoneal Low Grade Serous AdenocarcinomaRefractory Primary Peritoneal Transitional Cell CarcinomaRefractory Primary Peritoneal Undifferentiated CarcinomaNCT04739800National Cancer Institute (NCI)120
已完成
2 期
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV InfectionChronic Hepatitis CNCT02202980Gilead Sciences273
已完成
2 期
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT03662542Janssen Research & Development, LLC214
终止
1 期
Study of Safety and Tolerability of Multiple Intravenous Doses of ANZ-521 in Adults With Chronic Hepatitis C VirusChronic Hepatitis CNCT00800007Anza Therapeutics, Inc.5