Covid-19 living Data

Sofosbuvir/ledipasvir vs Standard care (RCT)

Mild outpatients

FOREST PLOTS -2022-08-18

Studies description

Trial NCT04498936
Publication Medhat M, Arab J Gastroenterol (2022) (published paper)
Dates: 2020-07-15 to 2021-10-30
Funding: Public/non profit (Egyptian Science, Technology and Innovation Funding Authority (STDF))
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Egypt Follow-up duration (days): 14
Inclusion criteria	COVID-19 diagnosis based on positive reverse-transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 on nasopharyngeal swabs Patients either attended, 1–2 days after diagnosis, to the outpatient clinic or were admitted to the quarantine hospitals of Helwan University Hospital, Al-Rajhy Liver University Hospital, and Tanta University Hospital, Egypt older than 18 years old creatinine clearance of >30 mL/ml without any malignancy non-severe COVID-19 infection, according to WHO cases definition, were included. Non-severe COVID-19 cases are defined by the absence of criteria for acute respiratory distress syndrome (ARDS), sepsis, septic shock, or other conditions requiring life sustaining therapies such as mechanical ventilation (invasive or non-invasive) or vasopressor therapy. All included patients had oxygen saturation >90% on room air and did not have signs of pneumonia nor signs of severe respiratory distress.
Exclusion criteria	Severe or critical COVID-19 infection with signs of ARDS, sepsis, septic shock patients required invasive or non-invasive mechanical ventilation ARDS is diagnosed when the PaO2/FiO2 ratio is < 200 pregnancy renal impairment with a creatinine clearance of <30 mL/min evidence of malignancies and use of FVP or LPV/RTV therapy
Interventions
	Treatment SOF/LDP 400 mg + 90 mg orally once a day for 14 days Nitazoxanide 500 mg orally four times a day for 14 days
	Control Standard care
Participants
	Randomized participants : SOF/LDP=70 Nitazoxanide =77 Standard care=73
	Characteristics of participants N= 220 Mean age : NR 100 males Severity : Mild: n= */ Asymptomatic: n=0
Primary outcome
	In the register 1) Change of PCR from positive to negative [ Time Frame: 2 weeks ] The PCR will be done at time of recruitment, day 5, 8, 11, and 14. The time taken to have negative will be measured in each group 2) Clinical improvement [ Time Frame: 2 weeks ] Clinical improvement will be measured by detection of downgrading of cases severity according to the World Health Organization case severity classification.
	In the report Viral clearance
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Only one of the two primary outcomes in the registry is reported in the article. The registry reports an additional primary outcome, clinical improvement. The trial (n = 220) did not achieve the target sample size in the registry (n = 240).