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

NCT ID: NCT04360980

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2021-01-30

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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

Group Type: ACTIVE_COMPARATOR

Colchicine Tablets

Intervention Type: DRUG

1.5 mg loading then 0.5 mg BID P.O

Standard treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Colchicine Tablets

1.5 mg loading then 0.5 mg BID P.O

Intervention Type: DRUG

Other Intervention Names

Colchicine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

nooshin dalili

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SBMU

Role: PRINCIPAL_INVESTIGATOR

CKDRC,SBMU

Locations

SBMU

Tehran, , Iran

Nooshin Dalili

Tehran, , Iran

Countries

Iran

References

Dalili N, Kashefizadeh A, Nafar M, Poorrezagholi F, Firouzan A, Samadian F, Samavat S, Ziaie S, Fatemizadeh S. Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jun 5;21(1):489. doi: 10.1186/s13063-020-04455-3.

Reference Type: DERIVED

PMID: 32503620 (View on PubMed)

Other Identifiers

SBMU.IR.REC.165423

Identifier Type: -

Identifier Source: org_study_id