Open-label, Randomized Trial of the Safety and Efficacy of Doxycycline and Rivaroxaban Therapy Versus National Standard Therapy in Ambulatory Patients With Mild Symptomatic COVID-19
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical
研究概览
简要总结
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg daily on D1 to D7) versus the combination of Hydroxychloroquine (400 mg on D1 to D7) and Azithromycin (500 mg on D1 and 250mg on D2 to D5) as per national standard to treat ambulatory mild COVID-19 patients, with the aim to achieve early negativity of RT-PCR of SARS-CoV-2 from nasopharyngeal swab, and early clinical improvement and prevention of severe disease.
详细描述
This is an exploratory study to evaluate the efficacy of Doxycycline (200mg on D1 to D7) and Rivaroxaban (15 mg on D1 to D7) versus combination of hydroxychloroquine (400 mg on D1 to D7) and azithromycin (500 mg on D1 and 250mg on D2 to D5) to treat ambulatory patients with mild COVID-19.
We aim to demonstrate early improvement of a clinical core set of outcomes and prevention of clinical worsening, and early negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) among ambulatory patients with mild COVID-19 by treating them with Doxycycline and Rivaroxaban compared to patients who receive Hydroxychloroquine and Azithromycin as per National standard therapy of COVid-19.
Ambulatory patients with mild symptoms and with confirmed diagnosis of COVID-19 will receive the treatment.
The primary objective of the study is to evaluate the Safety and Efficacy of Doxycycline and Rivaroxaban versus National standard therapy of mild COVid-19.
The primary endpoint is failure (i.e severe evolution) measured as PaO2 < 92% within 10 days after initiation of treatment.
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
- None
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
- •COVID-19 infection confirmed by SARS-Cov2 - RT PCR - as per protocol
- •Able to start the treatment within 24 hours from time of diagnosis
- •Patient with mild symptoms as defined by WHO, with PaO2 > 93%
- •Signed written consent of the patient
- •Accepts and has the ability to be reached by phone during the study duration, plus a designated a contact person who can be contacted in case of emergency
排除标准
- •Blood pressure < 90/60mm Hg
- •Respiratory rate ≥ 30/min
- •Known cardiac condition
- •Known G6PD deficiency
- •Patients with < 45kg
- •eGFR < 30 ml/min or ALT ≥ 3N or body temperature ≥ 38°C or any life-threatening comorbidity
- •Any reason that makes it impossible to monitor the patient during the study period
- •Baseline ECG prior to randomization showing QTc > 500 ms
- •Ongoing treatment other than symptomatic
- •history of retinopathy
- •Absolute contra-indication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment at risk of torsades de pointes)
- •Contraindication to any study medication including allergy
- •Ongoing treatment with high dose systemic chronic corticosteroid (> 40 mg)
- •Patients treated by immunosuppressants treatment at the time of randomization
- •Known Pregnant women and breastfeeding women
研究组 & 干预措施
Doxycyclin and Rivaroxaban
Oral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban
干预措施: Doxycycline Tablets (Drug)
Doxycyclin and Rivaroxaban
Oral Doxycyclin 200 mg daily for 7 days with or without Rivaroxaban
干预措施: Rivaroxaban 15Mg Tab (Drug)
National Standard
Hydroxychloroquine 400 mg daily for 5 days in combination with Azithromycin 500 mg on day 1 and 250 mg daily from day 2 through day 5
干预措施: Hydroxychloroquine and Azithromycin (Combination Product)
结局指标
主要结局
Clinical
时间窗: Day 1 to 10
Change of Clinical stage of COVID-19
Virological
时间窗: Day 1 to 10
Time to negativity of SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal swab.
次要结局
- Mortality(Day 1 to 10)
- Symptom remission(Day 1 to 10)
- Hospitalisation(Day 1 to 10)
- Biological variables(Day 1 to Day 7 and Day 10)
研究者
Sobngwi Eugene
Medical Director
Yaounde Central Hospital