COVID-19 SARS-nCoV-2 infection
Conditions
Interventions
Group 1: ARM 1 (Experimental): will receive continued standard of care therapy (as per the MOH protocol) together with a daily dose of one Gratisovir (Sofosbuvir) 400 mg tablet combined with one Dakta
Sponsors
PHARCO CORPORATE
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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 200mmHg under oxygen inhalation.
Exclusion criteria
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of clinical recovery (composite) within 14 & 21 days (Normalization of fever (=37.2 °C oral), Respiratory rate (=24/minute on room air), Oxygen saturation (=94% on room air)), sustained for at least 24 hours (using Exact test with Boot-Strapping). 2. Time to clinical recovery (composite) [Time frame: 21 days after randomization (using Kaplan Meier curve and Cox-regression). 3. Time to viral negativity assessed twice 48 hours apart (log10 viral load assessed by reverse transcription-PCR) during hospital stay (Kaplan Meier curve and Cox-regression). 4. Mean change in Clinical status using 8 point ordinal scale [Day 3 through Day 14, 21 (using Repeated measure Factorial ANOVA test]: 1) Death; 2) Hospitalized, on invasive ventilation or ECMO; 3) Hospitalized, on NIV or HFO2; 4) Hospitalized with oxygen supplement; 5) Hospitalized, not requiring oxygen but need medical care; 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized with normal activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who needed the use of mechanical ventilation during hospital stay [Time Frame: 21 days] (using Exact test with Boot-Strapping). 2. Proportions of Participants with Treatment Emergent Serious Adverse Events Leading to Study Drug Discontinuation (using Exact test with Boot-Strapping). | — |
Countries
Egypt
Contacts
Public ContactMostafa Yakoot
GREEN CRC
Outcome results
None listed