Randomized, open-label, prospective study to evaluate the safety and efficacy of sofosbuvir plus daclatasvir or ravidasvir in Egyptian adults with COVID-19

European Egyptian Pharmaceutical Industries (EEPI)0 个研究点目标入组 120 人开始时间: 2021年3月23日最近更新: 2021年12月21日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34379337/ (added 09/12/2021)

•1. Written informed consent signed and dated by the study subject or their legal representatives
•2. Age =18 years old
•3. Female or male patients with laboratory-confirmed symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected <72 hours before randomization
•4. Patients with any category of the following disease severity:
•4.1. Moderate:
•4.1.1. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
•4.1.2. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, saturation of oxygen (SpO2) ?90% on room air at sea level, heart rate =90 beats per minute
•4.1.3. No clinical signs indicative of severe or critical illness severity
•4.2. Severe (not critical): meeting the following criteria:
•4.2.1 Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
•4.2.2. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate =30 per minute, heart rate =125 per minute, SpO2 =90% on room air at sea level or PaO2/FiO2 <300
•4.2.3. No criteria for critical severity
•5. Radiographic evidence of pulmonary infiltrate

•1. Critically severe COVID-19 acute respiratory distress syndrome (ARDS) cases requiring invasive mechanical ventilation at screening
•2. Patients who have a severe concomitant illness that affects survival, including uncontrolled malignant tumor, blood dyscrasia, active bleeding, or patients with shock/or multiple organ failure at screening
•3. Hypersensitivity or contraindication to any of the drugs used in the study
•4. Patients with liver disease or cirrhosis (Child-Pugh >9 for ravidasvir and ?12 for daclatasvir) or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase [ALT] and aspartate aminotransferase [AST])
•5. Cardiac ischemia with history of recurrent angina, clinically symptomatic cardiac abnormalities, or requirement for cardiac pacemaker
•6. History of any malignancy within the last 5 years
•7. History of solid organ or bone marrow transplantation
•8. Patients who received treatment with any other investigational drug/device or involved in another clinical trial within 6 months prior to Screening
•9. People living with HIV
•10. Pregnant or breastfeeding subjects
•11. Patients unable to comply with the procedures described in the protocol
•12. Mentally or neurologically disabled patients not able to consent to their participation in the study

发起方

European Egyptian Pharmaceutical Industries (EEPI)