Status:
TERMINATED
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention
Lead Sponsor:
National and Kapodistrian University of Athens
Conditions:
Corona Virus Disease 19 (Covid 19)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colc...
Eligibility Criteria
Inclusion
- Patients \>18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature \>37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2\<95 mmHg.
Exclusion
- pregnancy, lactation;
- known hypersensitivity to colchicine
- known hepatic failure
- eGFR\<20 ml/min
- clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
- any clinical estimation of the attending physician under which the patient shall be excluded
- QTc \> 450 msec (colchicine is not known to significantly prolong QTc, but may interact with other medications which prolong QTc).
- participation in another clinical trial
- under colchicine treatment for other indications
- patient who is not likely to comply to study procedures
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04326790
Start Date
April 3 2020
End Date
April 27 2020
Last Update
April 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National and Kapodistrian University of Athens
Athens, Greece