Comparison of the effectiveness of Sovodak (sofosbuvir + Daklatasvir) and Keltra treatment regimens in patients with COVID-19: a randomized single-blind study

If the difference or greater effect of chloroquine + Sovodak is confirmed compared to the chloroquine + culture diet, the chloroquine + Sovodak diet regimen can be used as an alternative regimen or even treatment. Primary used in patients with coronary infection.

The study is a phase two, single-blind parallel clinical trial in which in each group 150 patients with a definite diagnosis of hospitalized coronary infection will be randomly assigned to two treatment groups in a ratio of 1: 1, chloroquine + treatment group Sovodak vs. Chloroquine + Keltra group therapy.

Phased double and single blind clinical trial study, in each group of 150 patients with a definitive diagnosis of corona virus infection admitted to Firoozgar and Rasoul Akram hospitals, will be randomly assigned to two treatment groups (chloroquine + Sovodak Vs. chloroquine + Kaletra group therapy). Patients and clinical staff in this study are blind.

Inclusion criteria: Definitive diagnosis of Covid-19 Age older than or equal to 18 years Inpatients Exclusion criteria: Pregnant women Breastfeeding women Patients who need treatment with four drugs from the beginning People with decreased level of consciousness Blood pressure less than 60/90 mm Hg Respiratory rate above 24 hypoxia Reduction of saturation less than 90% Patients with various organ failure Patients required mechanical ventilation at the time of admission

Patients with a definitive diagnosis of Corona virus infection admitted to Firoozgar and Rasoul Akram hospitals will be randomly assigned to two treatment groups (n-150 in each group) in a 1: 1 ratio chloroquine + Sovodak treatment group in Vs. chloroquine + Kaletra group therapy.

Mortality rate; Duration of hospitalization; Need to be admitted to the ICU

How patients are randomized will be classified as randomization blocks. Patients who need hospitalization are divided into four categories based on SpO2 and high-risk groups at the beginning of the visit, including patients in the high-risk group with SaO2 below 93%, patients in the high-risk group with high or equal SaO2 93%, patients in the group Low risk with SaO2 below 93% and finally patients in the low risk group with high SaO2 or equal to 93% will be divided. High-risk criteria include age over 60, with underlying disease such as immunodeficiency, diabetes, cardiovascular disease, obstructive pulmonary disease, malignancies, immunosuppressive patients, patients undergoing chemotherapy, chronic liver disease including cirrhosis and chronic disease Kidney will be considered. In each floor, blocks of size 4 are considered so that assuming the drug combination of chloroquine + Sovodak (sofosbuvir + Daklatasvir) as drug combination A and drug combination chloroquine + Kaletra as B, permutations of blocks in the form of AABB, ABAB, BBAA , BABA, ABBA, and BAAB will be produced. The sequence of blocks is randomly determined and patients in all four classes are named, thus depending on the time of referral will be placed in these blocks in order. It should be noted that the preparation of blocks and the placement of patients in blocks (assignment of patients to treatment groups) will be done by a third party who is not directly involved in the treatment of patients. Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study.

Medications will also be prescribed by the clinical staff (assistants of the relevant departments) who are not involved in conducting this study. And trying to be a double-blind experiment. Treatment regimen in group A. Hydroxychloroquine phosphate 400 mg single dose + lupinavir / ritonavir 400/100 combination twice daily for at least 5 days Treatment regimen in group B. Hydroxychloroquine phosphate 400 mg every 12 hours for the first day and then 200 mg every 12 hours for 5 to 7 days + Sovodak (sofosbuvir + Daklatasvir) once a day (60/400 mg) for at least 5 to 7 days It should be noted that each treatment regimen for each patient will be placed in separate envelopes with labels known only to the prescriber (a third party who will be selected by a medical staff that is not directly involved in the study). In order to blind the contents of the tablets Sovodak (sofosbuvir + Daklatasvir) and Kaletra, in coordination with a hospital pharmacologist, will be placed inside the same capsules whose contents have been emptied.

There is no further information.