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

   Details of VINCOV-19

Name of trial To evaluate the clinical safety, efficacy and tolerability of Equine Anti Covid Antibody Fragments F(ab’)2
CSIR lab/s involved Industry Sponsor/s & Scientific Collaborator/s Clinical Trial Site/s
CSIR-CCMB

 

 VINS BIOPRODUCTS LIMITED& UNIVERSITY OF HYDERABAD

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak

PCMC'S PGI Yashwantrao Chavan Memorial Hospital, Pune

Nobel Hospitals Pvt. Ltd, Pune

Sunshine Hospitals, Gachibowli, Hyderabad 

Vijay Vallabh Hospital and Medical Research Centre, Virar

Vijaya Super Speciality Hospital, Nellore
AMRI Hospitals, Bhubaneshwar

 
Type of Drug Equine Anti Covid Antibody Fragments F(ab’)2
IP Status of Drug/s
 
Mechanism of Action & Scientific rationale for Covid-19

 ANTI BODIES AGAINST COVID-19 VIRUS
Combinations therapy or monotherapy Monotherapy
Trial design

Health Condition / Problems Studied

 Health Type Condition
COVID19 patients

Moderate Sevrerity   

Number of trial sites       

Number of arms              

Number of patients         

07
02
223

Click here for End points (primary and secondary)

Phase – I - Primary End Point(s) – Safety

  • Primary Endpoint(s) - Safety
  • Incidence of Serious Adverse Events
  • Incidence of Treatment Emergent Adverse Events
  • Incidence of related Serious Adverse Events
  • Incidence of Grade 3 or 4 (severe) Adverse events

Phase – II - Primary End Point(s) – Safety

  • Time to Clinical recovery (TTCR) [Day 1 through Day 14] for which Day of recovery is defined as the first day on which the subject shows 2-point improvement in the ordinal scale.

Phase – II- Secondary – Safety

  • Incidence of Serious Adverse Events
  • Incidence of Treatment Emergent Adverse Events
  • Incidence of Grade 3 and above (severe) Adverse events
  • Incidence of related Serious Adverse Events
Status of the CSIR trial
Phase I & II Completed
Name & details of Clinical PI/s List

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