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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Colchicine Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04360980

SBMU.IR.REC.165423

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Intervention

Active Comparator group

Description:

40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment

Treatment:

Drug: Colchicine Tablets

Standard treatment

No Intervention group

Description:

40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days