Trial *
Publication El-Bendary M, Expert Rev Anti-Infe, 2021 (published paper)
Dates: 2020-02-01 to 2020-10-30
Funding: No specific funding (This paper was not funded)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Egypt Follow-up duration (days): 28 | |
Inclusion criteria | Adult male and non-pregnant female patients diagnosed with SARS-CoV-2 infection; evidence of pneumonia on CT chest. |
Exclusion criteria | Known allergy or hypersensitivity to the used medications; known seizure disorder, presence of either active HCV or severe liver disease (e.g., ;cirrhosis, elevated liver transaminases >5× the upper limit of the normal range); Pregnancy or breastfeeding; cases with history of bone marrow transplant, Glucose 6 phosphate dehydrogenase deficiency; end stage renal disease; psoriasis; porphyria and patients with a known history of long QT syndrome or current known QTc > 500 msec |
Interventions | |
Treatment
Sofosbuvir+Daclatasvir 400/60 mg once daily for 14 days |
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Control
Standard care ( / ) Definition of Standard care: Conventional therapy included Hydroxychloroquine (HCQ) (400 mg twice daily for one day, then 200 mg twice daily for 14 days).Other interventions were provided whenever indicated such as supplemental oxygen, noninvasive and invasive ventilation, antibiotic, systemic steroids, vasopressor support, renal-replacement therapy and extracorporeal membrane oxygenation (ECMO). | |
Participants | |
Randomized 174 participants (n1=96 / n2= 78) | |
Characteristics of participants N=174 Mean age : 51.1 95 males Severity : Mild: n=23 / Moderate: n=111/ Severe: n=4 Critical: n=0 | |
Primary outcome | |
In the register NR | |
In the report The rate of clinical/virological cure | |
Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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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, data from contact with authors was used in data extraction and assessment of risk of bias. No trial registry, protocol or statistical analysis plan were available. All participants completed the study. No data are reported on co-interventions received that may have altered the disease course.
The study was updated on the November 23rd, 2021 with data from contact with authors. |