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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00022203
• Date of registration: 15/06/2020
• Prospective Registration: Yes
• Primary sponsor: PHARCO CORPORATE
• Public title: Efficacy & Safety of Sofosbuvir/Daclatasvir treatment in COVID-19: A randomized, controlled study
• Scientific title: Efficacy & Safety of Sofosbuvir/Daclatasvir treatment in COVID-19: A randomized, controlled study
• Date of first enrolment: 20/06/2020
• Target sample size: 90
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00022203
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: 2-3

Countries of recruitment

Egypt

Contacts

• Name: Mostafa Yakoot
• Affiliation: GREEN CRC

• Name: Mostafa Yakoot
• Affiliation: GREEN CRC

Key inclusion & exclusion 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 < 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);

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19 SARS-nCoV-2 infection

Intervention(s)

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 Daktavera (Daclatasvir) 60 mg table, on Day 1 through day 10.
Group 2: ARM 2 (Active Comparator): will receive continued standard of care therapy (as the MOH protocol) together with a dose of 4 tablets of Plaquenil (Hydroxychloroquine) 200 mg, on Day 1 followed by 2 tablets daily from day 2 through 5.
Group 3: ARM 3 (No Intervention Control): will receive continued standard of care therapy (as per the MOH protocol without Hydroxychloroquine or the direct acting antiviral therapy).

Primary Outcome(s)

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 Outcome(s)

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).

Secondary ID(s)

U1111-1253-0458

Source(s) of Monetary Support

Pharco Corporate

Ethics review

Status: Approved
Approval date: 31/05/2020
Contact:

Research Ethics Committee, Egypt Ministry of Health and Population

Results

• URL: http://drks.de/search/en/trial/DRKS00022203#studyResults