Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Ivermectin Tablets; Colchicine 0.5 MG; Standared managment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days.; 0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days); (Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks
Other intervention name(s): Iverzine; Colchicine
Intervention MeSH terms: Ivermectin; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three arm randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ivermectin; Colchecine; COVID-19