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Safety and efficacy of sofosbuvir in the moderate COVID19

Evaluation of the Safety and Efficacy of Sofosbuvir in patients with moderate COVID19, A Single-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180302038915N1
Enrollment
50
Registered
2021-04-05
Start date
2021-04-14
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19. Coronavirus infection, unspecified

Interventions

Intervention 1: Intervention group: all the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted in the COVID ward with definitive moderate COVID19 diagno

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Both genders Age ranging from18 to 80 Y.O. who are admitted in hospital showing at least one of these criteria: Fever (Oral temperature = 38 ?) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio =300mgHg Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 ) 5 =days since onset of the COVID19 symptoms =10

Exclusion criteria

Exclusion criteria: History of allergic reaction to the drugs used in this clinical trial in a pregnancy or breast feeding status test Receipt of any experimental treatment for COVID-19 before hand Heart rate < 60/min currently on amiodarone prescription presence of multi organ failure evidence in need of mechanical ventilation estimated glomerular filtration rate < 50 0mL/1.73 m2/min admitted in ICU ward who are in shock

Design outcomes

Primary

MeasureTime frame
Time to reach clinical recovery. Timepoint: after 10 days on treatment initiation. Method of measurement: daily physical exam, assessing vanishing of tachypnea ,blood saturation of O2(using pulse-oximeter) , fever( using thermometer).

Secondary

MeasureTime frame
The rate of patients who need to admit in ICU ward. Timepoint: 14 days after Treatment initiation. Method of measurement: physical exam and paraclinical evaluation.;The rate of patient expiry in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: questionnaire.;Remission of clinical symptoms in each arm. Timepoint: 14 days after treatment initiation. Method of measurement: physical exam ( thermometer and pulse-oximeter).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFariba Ghorbani

Shahid Beheshti University of Medical Sciences

dr.f.ghorbani@gmail.com+98 21 2712 2163

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026