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 sites120 target enrollmentMarch 23, 2021

Overview

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

Registry

who.int

Start Date

March 23, 2021

End Date

March 10, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

European Egyptian Pharmaceutical Industries (EEPI)

•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

•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