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CUReD:  CSIR Ushered Repurposed Drugs -  A website that provides information on CSIR Partnered Clinical Trials.

   Details of Sofosbuvir + Daclatasvir

Name of trial Phase IIb Study to Evaluate the Efficacy and Safety of Sofosbuvir/Daclatasvir (sof/dcv) with or without Nitazoxanide or Favipiravir with Bromhexine in Combination with Standard of Care in Adult Patients with Moderate COVID-19 at Risk of Complications.
CSIR lab/s involved Industry Sponsor/s & Scientific Collaborator/s Clinical Trial Site/s

 

 Mylan Laboratories Limited.
CSIR (Knowledge partner)		 COVID-19 Treatment Centers or Hospitals
Type of Drug Sofosbuvir- Ant-Viral (HCV polymerase inhibitor) and Daclatasvir- Anti-viral (NS5A replication complex inhibitor)
Nitazoxanide- Anti-protozoal (pyruvate: ferredoxin/flavodoxin oxidoreductase (PFOR) cycle inhibitor)
Favipiravir- Anti Viral (RNA polymerase inhibitor)
Bromhexine- Mucolytic agent
IP Status of Drug/s Sofosbuvir and Daclatasvir- Approved for HCV treatment
Nitazoxanide- Approved for treatment of diarrhea
Favipiravir- Approved for treatment of viral influenza
Bromhexine- Approved as Expectorant and mucolytic
Yet to be approved in COVID-19 Indication
Mechanism of Action & Scientific rationale for Covid-19 Sofosbuvir is RNA polymerase inhibitor (inhibits replication) have high barrier for resistance. Daclatasvir-inhibits both viral RNA replication and virionassembly
Nitazoxanide- Depletes ATP-sensitive intracellular Ca2 stores, causes Impairment of viral reproduction and spread
Favipiravir- inhibits RNA-dependent RNA polymerase (RdRp) of RNA viruses (but not cellular RNA and DNA synthesis) and shows broad-spectrum antiviral activity against RNA viruses.
Bromhexine-selectively inhibits TMPRSS2 stopping the virus entry in host cell.
Combinations therapy or monotherapy Sofosbuvir/Daclatasvir (combination)
Sofosbuvir/Daclatasvir + Nitazoxanide (combination)
Favipiravir+ Bromhexine (combination)
Trial design Health Condition / Problems Studied Health Type Condition
  To Evaluate the Efficacy and Safety in Moderate COVID-19 patients
Number of trial sites       
Number of arms              
Number of patients         
20-25
04
To be confirmed

End points (primary and secondary)
Primary End Point-

  • SARS CoV2 negativity at Day 7
  • Time to Clinical Improvement at Day 15

Key Secondary end point-

  • Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) / SAEs;
  • Duration (days) of hospitalization
  • Incidence and Duration (days) of oxygen use 
  • Incidence and Duration (days) of mechanical ventilation
  • Morality rate at Day 29
Status of the trial  Regulatory (DCGI) review ongoing

Name & details of Clinical PI/s

 TBD

 

 

 

 

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