Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: A randomized double-blind clinical trial

Determination of the effect of sofosbovir / daclatasavir in COVID-19 patients

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 600 patients.

The study is a double-blind clinical trial. The sample size is 600. The samples are selected according to the entry criteria through the census and are assigned to the intervention and control groups by a simple random method.participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance.

Inclusion criteria: Age: 18-75 , Onset of symptoms 7 days or less (Symptoms include one of Fever (≥ 37.8°C at any one time), Dry cough, Severe fatigue, Dyspnea, CT involvement compatible with COVID, One of the below, Three or more lung lobes involved in CT ,O2Sat 94% or less Exclusion criteria: Renal failure (eGFR < 30), Bradycardia (HR < 50), Taking amiodarone, Previous COVID infection, Previous COVID experimental medicine , Pregnancy/lactation, Immune suppression/immune compromised, Active cancer, Multi-organ failure on admission (2 organs or more, excluding lung), Requiring intubation on admission, Significant arrhythmia in EKG , Allergy to sofosbuvir or daclatasvir, Severe disability preventing cooperation, Not consenting to the study

Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days. Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.

Recovery within 10 days from start of medication. Recovery defined as: (O2sat ≥95% or ≥5% improvement from baseline, No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance ) for 24 hours

Due to the frequent changes in the standard pharmaceutical protocol of the country

This study will be a randomized, double-blind, phase 3 clinical trials on 600 patients. Randomization method is block randomization and block size was 4. Sealed envelopes were used for allocation concealment.

In this study participants, researchers,Care provider, Data analyser and outcome assessor are blind. The drugs used were similar in appearance, So patients do not understand which group they are in. Sealed envelopes were used for allocation concealment.

-All data can be shared after the participants in the study are unrecognizable.

The data access period after printing the article

The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.

Any analysis can be done with the consent of the main researcher.

gholamali.eslami1351@gmail.com

The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.The project manager will then provide the requested information to the researcher or pharmaceutical company after ensuring the accuracy of the submitted documents after a period of one week.