Trial NCT04530422
Publication Elgohary M, medRxiv, 2021 (preprint)
Dates: 2020-04-15 to 2020-06-30
Funding: Not reported/unclear (None)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Egypt Follow-up duration (days): 21 | |
| Inclusion criteria | Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; demonstrated moderate cases criteria: fever (measured temperature of at least 38 °C), respiratory symptoms (cough, shortness of breath), and imaging-confirmed pneumonia; age more than 18 and less than 75 years old; Female patients enrolled in the study should have no planned pregnancy for six months, with the administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs; informed consent; no participation in other clinical trials within 30 days from the last administration of the study drugs. |
| Exclusion criteria | Mild COVID-19 patients who had mild symptoms without evidence of viral pneumonia or hypoxia and severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (R.R.) ≥ 30 times/min; (2) SaO2/SpO2 ≤ 93% in resting-state; (3) arterial partial pressure of oxygen (PaO2)/concentration of oxygen (FiO2) ≤ 300 mmHg; Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; (4) severe liver disease (such as child Pugh score ≥ C, AST > five times upper limit); patients with contraindications specified for any drugs used in the study or who received antiviral eradication therapy for hepatitis C or B viruses within the previous six months |
| Interventions | |
| Treatment
Sofosbuvir+Ledipasvir Once daily for 15 days. Dose not reported. |
|
| Control
Standard care ( / ) Definition of Standard care: * | |
| Participants | |
| Randomized 250 participants (n1=125 / n2= 125) | |
| Characteristics of participants N=250 Mean age : 43.5 59 males Severity : Mild: n=0 / Moderate: n=250/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Therapeutic success (cured) [Time Frame: 21 days]; 28 days in hospital mortality [Time Frame: 28 days] | |
| In the report Cure rate over time, length of hospital stay and the incidence of serious adverse events that lead to ICU admission or death | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. The study registration was retrospective (dated August 28, 2020 compared to study recruitment start date of April 15, 2020 as reported in the preprint). The registry reports treatment with Sofosbuvir plus Ledipasvir once daily for 15 to 21 days, whereas the article reports once daily for 15 days. The dosage of Sofosbuvir plus Ledipasvir was not reported in either the article or the registry. Primary outcomes in the report (cure rate over time, length of hospital stay and incidence of SAEs that lead to ICU admission or death) differed from those in the registry (cure defined as virological clearance in 2 samples at least 24 hours apart at 21 days, mortality at 28 days). There were also differences between secondary outcomes in the report (time to virological cure as detected by PCR and chest CT findings, laboratory outcomes) and the registry (clinical failure of treatments by PCR, length of hospital stay, side effects known to be related to the medication). Adverse events are not reported. |