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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930002
• Other study ID #: Drugs in COVID-19
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will be selected from Triage/COVID-19 Outpatient Clinic and every patients will be subjected to the following:

1. Clinical history will be obtained about socio-demographic data such as age, gender, residence, marital status, smoking history...etc, medical history including (weight, current medication, symptoms (onset, course, duration) and presence of Co-morbidities.

2. Full general examination including: temperature, heart rate, blood pressure, respiratory rate and oxygen saturation.

Suspected patients according to CDC criteria will be subjected to laboratory and radiological confirmation with (PCR-COVID-19, Complete Blood Count, CRP, Ferritin and D-Dimer) and High resolution CT chest.

After confirmation of the diagnosis and patients are classified as moderate with laboratory and radiological findings.

o Grouping: All patients enrolled in the study according the calculated sample size will be equally divided randomly into 3 groups using sealed envelope contain code for each group.

• Group A (Ivermectin group): COVID-19 patients with moderate severity who will receive standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals plus Ivermectin in the form of oral tablets e.g. (Iverzine 6mg) (200 mcg/kg/day) (4 tablets in the first day and then 2 tablet in the second and third day) on an empty stomach (Kaur et al., 2021).

Iverzine:

• Manufactured by: Unipharma Pharmaceutical Chemicals Co.

• Side effects of iverzine: Abdominal pain, Asthenia, Hypotension and Headache (Fujimoto et al., 2014).

o Group B (Colchicine group): COVID-19 patients with moderate severity who will receive standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals plus Colchicine 0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days) (Karatza et al., 2021).

Then all groups will receive instructions of home isolation.

Colchicine:

• Manufactured by: El Nasr Pharmaceutical Chemicals Co.

• Side effects of Colchicine: Gastro intestinal side effects e.g abdominal pain, vomiting, diarrhoea (Imazio et al., 2014).

o Group C (Control group): COVID-19 patients with moderate severity who will receive standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals (still not published) (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).

o Randomization: The researcher will use sealed envelopes containing code for intervention or control.

o Follow up: Participants will be followed up twice weekly by telephone evaluating their symptoms (increase or decrease, duration of symptoms and development of new symptoms) compliance on treatment, daily measurement of temperature, oxygen saturation, need for oxygen inhalation, need for hospital admission, ICU admission, mechanical ventilation, mortality and improvement of inflammatory markers (CBC, CRP, Ferritin and D-dimer).

o Final evaluation: Discharge from isolation after 10 days after symptom onset or10 days after their first positive swab (Teranaka et al., 2021).

Participants will be asked about improvement of symptoms or residual symptoms. Inflammatory markers (CBC, CRP, Ferritin and D-dimer) will be re-tested on day 14 then after 1 month from onset of symptoms.

o End point: The study will be continued up to complete the sample size, improvement of patient's symptoms, no development of new symptoms, need for hospitalization or ICU admission and Occurrence of adverse events (AES) or serious adverse events (SAEs) throughout the study duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 28, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Pregnant or lactating female.

• Any co-morbidities (DM, hypertension, Asthma……etc.).

• Participants receiving immunosuppressive or chemotherapy drugs.

• Active malignancy.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ivermectin Tablets
oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days.
• Colchicine 0.5 MG
0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)
• Standared managment
(Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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