Status:
COMPLETED
Colchicine Counteracting Inflammation in COVID-19 Pneumonia
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Conditions:
Coronavirus Infections
Pneumonia, Viral
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections \[3\]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory...
Eligibility Criteria
Inclusion
- Positive nasopharyngeal swab for COVID-19, asymptomatic or paucisymptomatic, aged ≥70 years and/or with clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) or
- symptomatic with respiratory or systemic symptoms, however clinically stable (MEWS\<3) with CT imaging showing viral pneumonia and positive or pending pharyngo-nasal swab for COVID-19: Temperature 38°C and/or intensive cough, Respiratory rate \< 25 /min, oxygen saturation (pulse oximetry) \>95%
- Positive swab for COVID-19
- with respiratory and/or systemic symptoms and initial mild respiratory failure e with objective signs of lung involvement; the patient is in stable conditions (MEWS \< 3) Temperature\>38°C and or intensive cough, Respiratory rate ≥25 /min, or oxygen saturation 94- 95% in room air
Exclusion
- Pregnant or breast feeding
- MEWS \>=3
- Hepatic failure Child-Pugh C
- Enrollment in other pharmacological studies
- Ongoing treatment with colchicine
- Ongoing treatment with antiviral drugs that include ritonavir or cobicistat
- Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT04322565
Start Date
April 20 2020
End Date
October 1 2021
Last Update
July 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy, 43100