Trial IRCT20130812014333N145
Publication Sayad B, J Antimicrob Chemother, 2021 (published paper)
Dates: 2020-04-11 to 2020-06-08
Funding: Public/non profit (The Research Council of Kermanshah University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Iran Follow-up duration (days): 28 | |
| Inclusion criteria | 18 years of age or older; oxygen saturation (SaO2)of 93% or less in ambient air and/or an absolute lymphocyte count of <1.1 cells/L; Positive PCR test for SARS-CoV-2 on a nasopharyngeal swab and/or a compatible chest CT scan |
| Exclusion criteria | pregnancy and breastfeeding; a physician’s decision against enrolment, conditions that did not allow complete implementation of the protocol; allergy or hypersensitivity to the drugs used in this trial; severe liver disease (e.g. cirrhosis or an ALT or AST level >5 times the upper limit of the normal range); use of medications that are contraindicated with the drugs used in this trial; known HIV infection (due to concerns about resistance to lopinavir/ritonavir if used without combination with other antiviral agents); known HCV infection (due to concerns about resistance to sofosbuvir/velpatasvir due to short-termuse of this drug); Patients who were unable to swallow received oralmedications through a nasogastric tube. |
| Interventions | |
| Treatment
Sofosbuvir/Velpatasvir 400 mg sofosbuvir and 100 mg velpatasvir orally once daily for 10 days. Patients who were unable to swallow received oral medications through a nasogastric tube. |
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| Control
Standard care ( / ) Definition of Standard care: National standard of care including 400mg hydroxychloroquine as a single dose and lopinavir/ritonavir (400mg/100mg) orally twice daily for 10 days as well as supplemental oxygen, non-invasive and invasive ventilation, antimicrobials, vasopressors and corticosteroids, if needed. | |
| Participants | |
| Randomized 80 participants (n1=40 / n2= 40) | |
| Characteristics of participants N=80 Mean age : 54.1 44 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=80 Critical: n=0 | |
| Primary outcome | |
| In the register Clinical status. Timepoint: Beginning of the study, 10 days later, or discharge time. Method of measurement: By a doctor | |
| In the report Mortality on Day 28 after randomization | |
| 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, the study registry was used in data extraction and risk of bias assessment. A protocol or statisitcal analysis plan was not available. The study achieved the target sample size specified in the trial registry. The primary outcome in the article (mortality on Day 28 after randomization) differed from that in the registry (clinical status, beginning of the study, 10 days later, or discharge time). Secondary outcomes reported in the article were not included in the registry. Study described as single-blinded in the registry (patients) but open-label in the article. |