Comparison of the therapeutic effect of Sofosbuvir with Control group in outpatients with Covid-19 referred to outpatient clinics in Ahvaz

To evaluate whether (Sofosbuvir ) increases significant clinical improvement as compared to standard of care in out patients patients with mild COVID-19

This is a parallel 2-arm randomized, controlled, double- blind, multi center study. 360 patients are enrolled and followed for 14 days

This study will be performed in outpatient medical centers in Ahvaz by researchers from the Lung Diseases Research Institute. Physicians who evaluate results and statistics that analyze data become blind, and patients and physicians who treat patients do not know the specific treatment group.

Inclusion criteria: Outpatients with positive PCR and mild clinical signs without pulmonary involvement on CT scan. (As defined by patient with sore throat, dry cough ±, loss of sense of smell and taste, body aches, nausea and vomiting, O2 Sat ≥ 95, T <38, RR <24, stable pulse and blood pressure). Exclusion criteria: 18y> age, transplant patients, severe skin history including TEN or Steven Johnson, allergy or allergy to the drug Male study, the patient has previously been treated with this drug for other reasons (hepatitis C, etc.) , Is not able to take pills, is not aware of his condition, is deficient in G6PD enzyme, is being treated with anticonvulsant drugs, has fever and respiratory symptoms for 2 weeks, is being treated with immunosuppressive drugs, 1 month ago drugs Has received antiviral for Covid-19, is pregnant or lactating, has ESRD, Advance CKD (liver, lung, heart, hematology) and solid tumors and cancers of neurological diseases such as CVA, etc., are excluded.

360ligible patients with mild COVID-19 in a 1:1 ratio: • Standard of care treatment • tablet (Sofosbuvir 400mg) + Standard of care treatment

Clinical recovery (composite) within 14 days

The nature of assigning patients to each of the two study groups was a randomized block method in which a 6-item block was used according to 60 6-item blocks. A: S B: c . In this way, patients are not aware of the treatment assigned to them. Also, the person evaluating the outcome of the treatment is kept unaware of the type of treatment. Blinding then Allocate Allocation In order to minimize the bias in the study, the Allocate method will be used. This will be done using unique codes or Uniqe code. In such a way that each person is assigned a three-digit number at random.

The task of treatment will remain unknown until the patient is random. Physicians who treat patients will remain blind. Physicians who evaluate results and statistics that analyze data will all become blind.

The individual data of the participants in the study of all potential data can be shared after the identifiable individuals

Access period starts from 1400

The data will be available only to researchers working in academic and scientific institutions

Only SPSS data will be available.

09133583977

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