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IRCT20200403046926N1

The effect of SOVODAK in the treatment of COVID-19 patients

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (12)
  2. Male and Female
  3. COVID-19
  4. Infant
  5. Adult
  6. Aged (65+)
  7. Child
  1. Intervention (6)
  2. Naproxen
  3. Pantoprazole
  4. Azithromycin
  5. Hydroxychloroquine
  6. Sofosbuvir
  7. Daclatasvir
  1. Comparison (4)
  2. Hydroxychloroquine
  3. Azithromycin
  4. Naproxen
  5. Pantoprazole
  1. Outcome (5)
  2. Clinical Resolution
  3. Lymphopenia
  4. Oxygen Saturation
  5. C-reactive Protein
  6. Hospitalization

The effect of SOVODAK in the treatment of COVID-19 patients

Mazandaran University of Medical Sciences
First Published 2020ICTRP (http://en.irct.ir/trial/46926)
Trial registry record
No Results
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 A
First Published 2020Journal of Antimicrobial Chemotherapy (https://pubmed.ncbi.nlm.nih.gov/33338232)
Journal article
Report Results
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