The effect of SOVODAK in the treatment of COVID-19 patients
Mazandaran University of Medical SciencesTrial registry record
Condition: COVID-19. Coronavirus infection, unspecified;B34.2
Inclusion criteria: Diagnosis by CT scan with clinical symptomsConsent to attend the studyLymphocyte count less than 1100Positive CRP test.
Intervention 1: Intervention group: COVID-19 Patients receiving hydroxychloroquine + SOVODAK.
Intervention 2: Control group: COVID-19 Patients receiving hydroxychloroquine.
Primary outcome: Symptoms ending. Timepoint: During the study. Method of measurement: Clinical examination.;Lymphopenic Status. Timepoint: Before the intervention and the seventh day. Method of measurement: Counting lymphocytes.;C-reactive protein Status. Timepoint: Before the intervention and the seventh day. Method of measurement: C-reactive protein serological test.;Saturation of Peripheral Oxygen. Timepoint: Before the intervention and the seventh day. Method of measurement: Pulseimetry
Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial
Roozbeh F, Saeedi M, Alizadeh-Navaei R, Hedayatizadeh-Omran A, Merat S, Wentzel H, Levi J, Hill A, Shamshirian AJournal article
INTRODUCTION: Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection.
METHODS: This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1.
RESULTS: Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm (n = 27) or the control arm (n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001.
CONCLUSIONS: In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted