COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA

Phase 1

• Conditions: patients with COVID-19 infection with pneumonia and stable conditions.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001258-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

-Patients aged 18 years or above
-Belonging to the low- to intermediate-risk strata according to the criteria of the Emilia-Romagna Region, Italy (PG/2020/0240975 del 21 marzo 2020 Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19”, Scenario 2 and 3A, in a scale of increased levels of severity) and to the SIMIT guidelines (http://www.simit.org/IT/formazione/linee-guida.xhtml)), that is patients in stable medical conditions (MEWS<3, see Table below) with the following characteristics:

-Pauci-symptomatic with positive nasopharyngeal swab for COVID-19 + age =70 years and/or clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) + even minimal CT scan findings (>5% of lung parenchima) suggestive of viral pneumonia (ground-glass opacities and/or patchy consolidation, and/or interstitial changes with a peripheral distribution)

- Symptomatic (temperature =38°C and/or intensive cough and/or shortness of breath), + CT imaging showing typical findings of viral pneumonia (ground-glass opacities, multifocal patchy consolidation, and/or interstitial changes with a peripheral distribution) and positive or pending pharyngo-nasal swab for COVID-19.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Unstable clinical conditions (MEWS=3)
- Respiratory rate > 30 rpm, PaO2/FiO2 < 200mmHg
- Pregnant or breast feeding
- Hepatic failure Child-Pugh C
- Enrollment in other pharmacological studies
Treatment with
- Chronic treatment with colchicine
- Ongoing treatment with antiviral drugs that include ritonavir or cobicistat (Previous treatment with antiviral drugs that include ritonavir or cobicistat is NOT an exclusion criteria)
- Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified