The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Colchicine Tablets

• Registration Number: NCT04360980
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .

Detailed Description

80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.

Exclusion Criteria

• Patient who is not willing to enter in study
• Known hypersensitivity to colchicine
• Hepatic failure
• Renal failure with eGFR<20 ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Colchicine Tablets	40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment

Primary Outcome Measures

Name	Time	Method
Clinical deterioration by the WHO definition	2 weeks	including change in fever or O2 Saturation
PCR Viral Load	2 weeks	change in RT-PCR
CRPxN/R ratio change	2 weeks	increasing inflammatory status
CT severity involvement index	2weeks	change in CT involvement

Secondary Outcome Measures

Name	Time	Method
LDH change	2 weeks	change in LDH

Trial Locations

Locations (2)

SBMU; 🇮🇷 Tehran, Iran, Islamic Republic of

Nooshin Dalili; 🇮🇷 Tehran, Iran, Islamic Republic of