meta|Evidence - COVID-19
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sofosbuvir and daclatasvir (n=541) vs. placebo (n=542)
randomized controlled trial some concerns about risk of bias
Sofosbuvir/Daclatasvir
Sofosbuvir/Daclatasvir 400/60mg (Sovodak, RojanPharma, Tehran) once daily for 10 days with standard care.
Placebo
Standard care plus an identically-looking placebo tablet once daily for 10 days.
All participants received standard care following national treatment guidelines.
COVID 19 hospitalized
Patients with clinically diagnosed COVID-19 by either PCR positivity or COVID-19 compatible lung chest CT scan findings were considered for inclusion if they were >18 years old and provided written informed consent. In addition, patients were required to have any one of fever (oral temperature ≥ 37.8 °C), dry cough, severe fatigue, dyspnea, and oxygen saturation<95%.
Double-blind.
Multicenter, 19 hospitals in 12 cities in Iran.
Subjects were discharged based on the managing physician’s decision and when clinical recovery was evident defined as 24 hours of no fever or dyspnoea, no or improved cough and fatigue, and tolerance of oral feeding.
sofosbuvir and daclatasvir (n=541) vs. placebo (n=542)
randomized controlled trial risk of bias NA
Sofosbuvir/Daclatasvir
Sofosbuvir/Daclatasvir 400/60 mg administered orally once-daily for 10 days in addition to standard of care.
Placebo
Placebo for 10 days in addition to standard of care.
Standard of care was administered following national treatment guidelines, which varied throughout the study and included concomitant use of interferon-b, dexamethasone (or other corticosteroids), lopinavir/ritonavir and other therapeutic agents.
COVID 19 hospitalized
Individuals were required to have an oxygen saturation <95% and at least one symptom of fever (oral temperature 37.8C), dry cough, severe fatigue or dyspnoea. Patients were excluded if they had multi-organ failure or required intubation on admission.
Double-blind.
19 hospitals across 12 cities in Iran.
Patients were discharged on the managing physician’s decision based on the absence of fever or dyspnoea, no or improved cough and fatigue, and tolerance of oral feeding, with a stable O2 saturation of 95%. During the first 2 weeks of the study, the 95% O2 saturation criterion for clinical recovery and subsequent discharge was not possible to enforce due to shortages of hospital beds. As such, at the beginning of the third week of the study this final criterion was removed.
sofosbuvir and daclatasvir (n=35) vs. standard of care (n=35)
randomized controlled trial some concerns about risk of bias
Sofosbuvir/Daclatasvir
Single daily oral tablet containing 400mg sofosbuvir and 60mg daclatasvir (Sovodak, RojanPharma, Tehran, Iran) in addition to standard care for 14 days. Treatment started 24-48h after admission.
Standard of care
Standard of care alone.
All patients received standard care according to the national Iranian COVID-19 treatment guidelines which at the time of the study was hydroxychloroquine 200mg twice daily with or without lopinavir/ritonavir 200mg/50mg twice daily.
COVID 19 hospitalized
All adult patients aged at least 18 years admitted with suspected COVID-19 with positive qualitative RT–PCR on nasopharyngeal swab AND chest CT scan compatible withmoderate or severe COVID-19 infection. In addition, participants were required to have signs of severity of disease defined as fever (oral temperature>=37.8°C at any one time prior to enrolment) and at least one of respiratory rate >24/min, O2 saturation <94% or PaO2/FiO2 ratio <300 mgHg.
Open-label.
Four university hospitals in Iran.
Clinical recovery was defined as normalization of fever (<=37.2°C),respiratory rate (<=24/min) and oxygen saturation (>=94%) without supplementary oxygen therapy sustained for at least 24h.If patients maintained these criteria for over 24 h they were safely discharged from hospital.
sofosbuvir and daclatasvir (n=44) vs. standard of care (n=45)
randomized controlled trial some concerns about risk of bias
Sofosbuvir/Daclatasvir
One 400 mg tablet sofosbuvir and one 60 mg daclatasvir daily for 10 days in addition to standard of care.
Standard of care
Standard of care alone.
Standard of care, according to the Egyptian MOH Protocol, was given to all patients: Plaquenil (Hydroxychloroquine) which was given in a dose of 4 tablets of 200 mg, on Day 1 followed by 2 tablets daily from day 2 through day 5. Azithromycin was given in a daily dose of 500 mg for 5 days. Full nutritional support with balanced diet and multivitamin and zinc supplements with vitamin C and D were offered to all patients.
COVID 19 hospitalized
Males or females between 18 and 75 years of age and presenting with laboratory-confirmed COVID19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected within 72 hours prior to randomization; in addition to being symptomatic at screening, presenting with clinical manifestations under one of three severity categories: Mild, Moderate or Severe disease. Patients with critically severe COVID19 requiring invasive mechanical ventilation at screening were excluded.
Open-label.
Single center in Cairo, Egypt.
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