A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of Patients With Early Clinical Improvement
研究概览
简要总结
On 31 December 2019, the World Health Organization (WHO) was formally notified about a cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped viruses.
Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of this universe. Management of the COVID-19 relies on mainly supportive care and oxygen supplementation via non-invasive or mechanical ventilation in critical cases. Patients who are critically ill may also require vasopressor support and antibiotics for secondary bacterial infections.
There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a tremendous effort around the world to develop effective preventive and therapeutic treatment for this disease.
World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other drugs in the SOLIDARTY trial are quite expansive for resource limited countries like Bangladesh.
Study Published in the American Journal of Tropical Medicine advocates further research into Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2 coronavirus in vitro studies.
In different study Doxycycline also showed promising results in treatment of COVID 19 infection. It is highly lipophilic antibiotics that are known to chelate zinc component of matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for survival, cell infiltration and replication. It also has an anti-inflammatory effect which might be effective in combating cytokine storm of Covid-19 infection.
So it have been planned to conduct an experimental clinical trial using combination of ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.
详细描述
OBJECTIVES:
General objectives:
To observe the benefit (clinical and microbiological) of Ivermectin and Doxycycline in Confirmed Covid 19 cases.
Specific objectives:
- To observe the clinical outcome in trial group and the placebo group.
- To observe the duration require controlling viral replication (negative RT-PCR) in the trial and placebo group.
- To compare the outcome between the two groups.
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)
盲法说明
Double blind (The participant and the clinicians/data collectors will be unaware of the treatment the participant receives).The drugs will be labelled with a random code number
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 polymerase chain reaction (PCR) test within 3 days from enrollment
- •Only mild and moderate COVID-19 infected cases
- •Able to provide informed consent
排除标准
- •Unable to take oral medication
- •Pregnant or breast feeding lady
- •Patients with severe COVID symptoms or admission in ICU/HDU
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper limit of normal (ULN)
- •On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
- •Known hypersensitivity to Doxycycline or ivermectin or its components.
研究组 & 干预措施
Ivermectin and Doxycycline
Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days
干预措施: Ivermectin and Doxycycline (Drug)
Ivermectin and Doxycycline
Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days
干预措施: Standard of care (Drug)
Placebo
Standard treatment
干预措施: Standard of care (Drug)
结局指标
主要结局
Number of Patients With Early Clinical Improvement
时间窗: 7 days
Number of patients have clinical improvement as described by WHO and Bangladesh local guideline with 7 days.. 1. Body temperature remains normal for at least 3 days (ear temperature is lower than 37.5 °C). 2. Respiratory symptoms are significantly improved. 3. Lung imaging shows obvious improvement in lesions. 4. There is no co-morbidities or complications which require hospitalization. 5. SpO2, \>93% without assisted oxygen inhalation.
Number of Participants With Late Clinical Recovery
时间窗: 12 days
Number of the patients required more than 12 days for clinical improvement as defined above.
次要结局
- Number of Patients Having Clinical Deterioration.(1 month)
- Number of Patients Remain Persistently Positive for RT-PCR of Covid-19(14 days)
研究者
Dr. Reaz Mahmud
Assistant Professor
Dhaka Medical College