Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial

NCT05930002 | Completed DMC

• 1 other identifier: Drugs in COVID-19
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Corona virus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), a new corona virus that emerged in Wuhan, China, in December 2019. It spread rapidly throughout the world causing great mortality. Till date, there is no specific treatment for COVID-19; Ivermectin and colchicine were proposed as therapeutic options for treatment of COVID-19. Our randomised controlled clinical trial aims to assess the effectiveness of ivermectin and colchicine for treating COVID-19.

Conditions

COVID-19

Keywords

Ivermectin; Colchecine; COVID-19

Outcome Measures

Primary Outcomes (4)

• duration and number of symptoms

  Participants were followed up twice weekly for one month. They were called by phone to ask about their symptoms e.g: they were asked about symptoms relief, number of symptoms, duration of symptoms e.g cough, fever (temperature measurement by thermometer)

  one month

• Concentration of inflammatory markers (CBC, CRP, Ferritin and D-dimer )

  Patients were asked to do inflammatory markers (CBC, CRP, Ferritin and D-dimer ) in the first 5 days as initial labs . Two weeks later, patients were followed up in the clinic. They were asked to repeat the primary investigations (CBC, CRP, Ferritin and D-dimer). After one month of symptoms onset, patients were followed up in the clinic and the previous investigations (CBC, CRP, Ferritin and D-dimer) were re-tested

  one month

• need for oxygen inhalation

  Patients were asked to measure oxygen saturation daily and according to the measurement, the need for oxygen was determined.

  one month

• need for hospital admission, ICU admission, mechanical ventilation and mortality.

  Patients were assessed for the need of hospital admission, ICU admission, mechanical ventilation or if mortality documented. all these measures were done according to oxygen saturation measurement , investigations and assessment of symptoms if they improve or deteriorate

  one month

Study Arms (3)

Ivermectin group

ACTIVE COMPARATOR

received standard treatment plus Ivermectin in the form of oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days

Drug: Ivermectin Tablets

Colchicine group

ACTIVE COMPARATOR

received standard treatment plus Colchicine 0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)

Drug: Colchicine 0.5 MG

Control group

ACTIVE COMPARATOR

received the standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals (http://scu.eg/pages/university\_hospitals) (Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks and needed protocol of management according to case assessment and severity)

Drug: Standared managment

Interventions

Ivermectin Tablets DRUG

oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days.

Also known as: Iverzine

Ivermectin group

Colchicine 0.5 MG DRUG

0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)

Also known as: Colchicine

Colchicine group

Standared managment DRUG

(Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged (18-64) years with confirmed criteria of COVID-19 infection.
• Moderate Cases: Patients have symptoms (such as fever, respiratory tract symptoms), pneumonic manifestations can be seen in chest imaging and oxygen saturation more than 94% (Egyptian Ministry of Health and Population, 2020).

You may not qualify if:

• Pregnant or lactating female.
• Any co-morbidities (DM, hypertension, Asthma……etc.).
• Participants receiving immunosuppressive or chemotherapy drugs.
• Active malignancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Using sealed envelopes for either participants or controls
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of family medicine

Model Details: Three arm randomized controlled clinical trial

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 5, 2023
• Study Start: July 21, 2021
• Primary Completion: September 9, 2022
• Study Completion: December 28, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)