Covid-19 Living Data

Trial ISRCTN21085622
Publication Abbass S, J Med Virol (2021) (published paper)
Dates: 2020-09-01 to 2021-03-30
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 criteria	aged >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 criteria	Critically 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 Sofosbuvir-Daclatasvir SOF 400 mg once a day orally + DCV 60 mg once a day orally for 10 days SOF-RDV SOF 400 mg once a day orally + RDV 200 mg once a day orally for 10 days
	Control Standard care
Participants
	Randomized participants : Sofosbuvir-Daclatasvir=40 SOF-RDV=40 Standard care=40
	Characteristics of participants N= 120 Mean age : NR 64 males Severity : Mild: n=0 / Moderate: n=46 / Severe: n=74 Critical: n=0 Number of vaccinated participants: NR
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 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 Days 7 and 10, controlling for the corresponding count of symptoms at Day 3 for each patient; 2. mean change in oxygen saturation from Day 1 to Day 10 (based on daily recording per CRF)
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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.