Working…
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered SARS-CoV-2.
Protect yourself and others from infection by washing your hands, wearing masks or using an alcohol based rub frequently and not touching your face.

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

   Details of Favipiravir + Bromohexine

Name of trial FaBCoV  (Investigator Driven Trial)
CSIR lab/s involved Industry Sponsor/s & Scientific Collaborator/s Clinical Trial Site/s
CSIR-Indian Institute of Chemical Biology (IICB), Kolkata

 

 CIPLA is donating both the API needed in the trial ID & BG Hospital (COVID Hospital), Beleghata, WB, Kolkata, WB

 
Type of Drug Favipiravir and Bromhexine
IP Status of Drug/s Out of patent
Mechanism of Action & Scientific rationale for Covid-19
  1. FAVIPIRAVIR: Targets Virus RNA-dependent RNA polymerase (RdRp)
  2. RdRp is considered to be one of the most promising targets for the treatment of COVID-19.
  3. Bromhexine is selective TMPRSS2 (host serine protease) inhibitor.
  4. Bromhexine interference with viral host cell entry
Combinations therapy or monotherapy

Combination therapy with Favipiravir and Bromhexine
Trial design

Health Condition / Problems Studied

 Health Type Condition

Inclusion criteria: 

Patients (aged >18 years) hospitalized with RT-PCR proven COVID-19, without evidence for development of acute respiratory distress syndrome (PaO2/FiO2 ≥300 mmHg) within 7 days from initial presentation & 5 days of hospitalization.

Exclusion criteria:

  • Pregnant or breastfeeding mothers
  • Patients with age less than 18 years
  • Patients having ARDS (PaO2/FiO2 ≥300 mmHg)
  • Admitted late after 7 days of initial presentation
  • Participating in any other clinical trial
  • Patients refusing consent

Number of trial sites       

Number of arms              

Number of patients         

01
04
120 (30 pateints in each arm)

PRIMARY OBJECTIVES
1.  To compare time taken to negative viral RNA PCR
2.  To determine safety profile of the combination drugs
3.  Determine the kinetics of development of protective immunity in relation to viral load kinetics
SECONDARY OBJECTIVES
1. To compare progression to moderate or severe ARDS
2. To compare 28 days mortality between treatment groups

Status of the CSIR trial
Ethical clearence has been obtained from the trial site ID & BG Hospital, Kolkata.

Name & details of Clinical PI/s

 Dr. Arindam Talukdar, PhD
(PI and Coordinator)
Principal Scientist CSIR-Indian Institute of Chemical Biology, Kolkata

 

 

Dr. Rammohan Roy, MBBS, MD, DM (Trial site Investigator)

Assistant Professor, Department of Medicine, ID and BG Hospital, Kolkata (COVID Hospital)

 

 

 

Dr. Dipyaman Ganguly, MBBS, PhD, PhD
Principal Scientist
CSIR-Indian Institute of Chemical Biology, Kolkata.

Dr. Yogiraj Ray, MBBS, MD, DM
Assistant Professor, Calcutta School of Tropical Medicine
& ID and BG Hospital, Kolkata

Dr. aushik Chaudhury, MBBS, DTCD
Nodal Officer and Pulmonologist
ID & BG Hospital, Kolkata

Dr. Shekar Ranjan Paul, MBBS, DPH, DTCD
Senior Resident,
ID & BG Hospital, Kolkata

Dr. Sandip Paul, PhD

Back