Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Therapeutic success (cured)
研究概览
简要总结
Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.
This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).
详细描述
This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19).
Randomization (in RCT only)
Once enrolled in the study, patients randomly assigned to one of the following groups:
- Group I (SL group, n=125): patients received Sofosbuvir plus Ledipasvir.
- Group II (OCH group, n=125): patients received Oseltamivir plus HCQ & Azithromycin.
Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope.
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
- Single (Participant)
盲法说明
Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope to assign the patient to group 1 either group 2
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °C", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia").
- •Female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs.
- •Patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.
排除标准
- •Severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (RR) ≥ 30 times / min; (2) SaO2 / SpO2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤ 300 mmHg
- •Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; severe liver disease (such as child Pugh score ≥ C, AST > 5 times upper limit);
- •Patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis C or B viruses within the previous 6 months.
- •Patients with chloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
- •Any patient demonstrates worsening of symptoms, radiological progression with virologically persistence within at least 5 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol.
- •Treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died .
研究组 & 干预措施
• Group I (Sofosbuvir plus Ledipasvir)
Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir, once daily for 15 to 21 days as minimum and maximum duration of therapy, respectively.
干预措施: Sofosbuvir plus Ledipasvir (Drug)
Group II (Oseltamivir plus HCQ & Azithromycin)
Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19:
- Oseltamivir 150 mg q 12 hours for 10 days ;
- HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
- Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
- Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 & 11 clinically
干预措施: Sofosbuvir plus Ledipasvir (Drug)
结局指标
主要结局
Therapeutic success (cured)
时间窗: 21 days
Cured: Documented virological clearance in 2 samples at least 24 hours apart.
28 days in hospital mortality
时间窗: 28 days
any incidence of deaths for any participant within 28 days from starting the treatments
次要结局
- Percentage of clinical failure of treatments(21 Days)
- Length of hospital stay(Through study completion, an average of 14 weeks)
- Incidence of side effects(21 days)
研究者
Mohamed Abdelsalam El-Gohary
Head of Almaza Military Fever Hospital
Almaza Military Fever Hospital