Trial ISRCTN21085622
Publication Abbass S, 2021 (published paper)
Dates: 9/1/2020 to 3/30/2021
Funding: Private (Pharco Pharmaceuticals / European Egyptian Pharmaceutical Industries (EEPI))
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Egypt
Follow-up duration (days): 17
Inclusion criteriaaged >18 years; laboratory-confirmed symptomatic COVID-19 as determined by PCR assay in any specimen collected <72 h before randomization; willing and able to provide written informed consent; have the following disease severity grades: moderate (patients with respiratory rate ≥20 breaths/min, oxygen saturation measured through a pulse oximeter [SpO2] >90% on room air and heartrate ≥90 beats/min), severe (not critical) (patients with clinical signs indicative of severe systematic illness with COVID-19; such as respiratory rate ≥30/min, heart rate ≥125/min, SpO2≤ 90% on room air or PaO2/FiO2 <300). Degrees of severity of COVID-19 were defined according to the WHO’s COVID-19 disease severity classification.
Exclusion criteriaCritically severe COVID-19 requiring invasive mechanical ventilation at screening; severe concomitant illness; hypersensitivity or contraindication to any of the drugs used in the study; liver cirrhosis or elevated ALT, and/or AST above three times the upper limit of normal; cardiac ischemia or clinically symptomatic cardiac abnormalities; history of any malignancy within the last 5 years; history of solid organ or bone marrow transplantation; received treatment with any other investigational drug/device or involved in another clinical trial within 6 months before screening; people living with HIV; pregnant or breastfeeding.
Interventions
Treatment 1
Sofosbuvir+Daclatasvir
Control
Standard care
Control
Sofosbuvir+Ravidasvir
Participants
Randomized
120 participants n1=40/ n2=40/ n3=40
Characteristics of participants
N=120
Mean age : 44.7
64 males
Severity : Mild: n=0 / Moderate: n=46/ Severe: n=74 Critical: n=0
Primary outcome
In the register
1. Sum of the counted symptoms (fever, headache, generalized aches (myalgia/arthralgia); respiratory distress combined with no evidence of deterioration (ICU admission and mechanical ventilation) at days3, 7 and 10;2. Mean Oxygen saturation from day 1 to day 10 (based on daily recording as per CRF)
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

NR
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. Neither protocol nor statistical analysis plan was available. The primary and secondary outcomes reported in the article reflect those in the registry, which was retrospective. The study achieved the target sample size specified in the trial registry.