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

COVID-19 Clinical Trial

Official title:

Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360980
• Other study ID #: SBMU.IR.REC.165423
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Colchicine Tablets
1.5 mg loading then 0.5 mg BID P.O

Locations

Country	Name	City	State
Iran, Islamic Republic of	Nooshin Dalili	Tehran
Iran, Islamic Republic of	SBMU	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRPxN/R ratio change	increasing inflammatory status	2 weeks
Primary	Clinical deterioration by the WHO definition	including change in fever or O2 Saturation	2 weeks
Primary	PCR Viral Load	change in RT-PCR	2 weeks
Primary	CT severity involvement index	change in CT involvement	2weeks
Secondary	LDH change	change in LDH	2 weeks