Efficacy & Safety of Sofosbuvir/Daclatasvir treatment in COVID-19: A randomized, controlled study

Phase 2

Recruiting

Conditions: COVID-19SARS-nCoV-2 infection

Registration Number: DRKS00022203

Lead Sponsor: PHARCO CORPORATE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

(1) Subjects or their legal representatives have signed the informed consent form (ICF).
(2) Subjects are aged = 18 and = 75;
(3) Has laboratory-confirmed Symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected < 72 hours prior to randomization and any clinical severity category of the following:
A. Mild: mild clinical symptoms with no picture of pneumonia in CT, but positive 2019-nCoV2 in throat/nasal swabs.
B. Moderate: fever, respiratory symptoms, etc., pneumonia visible in CT.
C. Severe (Not Critical): meeting any of the following criteria:
(a) Respiratory distress, RR=30 times/min;
(b) Finger oxygen saturation =93% in rest state;
(c) Arterial partial pressure of oxygen / concentration of fractional inspired oxygen (PaO2/FiO2) =400mmHg and > 200mmHg under oxygen inhalation.

Exclusion Criteria

(1) Patients with pneumonia due to other etiology.
(2) Critically severe COVID19 ARDS cases Requiring invasive mechanical ventilation at screening;
(3) Patients who have severe concomitant illness that affects survival or course of the disease, including uncontrolled malignant tumor, HIV, blood dyscrasia, active bleeding or patients with shock/or multiple organ failure at screening.
(4) Pregnant or lactating females.
(5) Hypersensitivity or contraindication to any of the experimental drugs used in the study (Prolonged QT syndrome, G6PD deficiency, psoriasis, retinal damage or others). .
(6) Patients with decompensated liver cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase (ALT) and aspartate aminotransferase (AST);
(7) Renal dysfunction (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2);