Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial
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ClinicalTrials.gov Identifier: NCT05930002 |
Recruitment Status :
Completed
First Posted : July 5, 2023
Last Update Posted : July 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Ivermectin Tablets Drug: Colchicine 0.5 MG Drug: Standared managment | Not Applicable |
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Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Three arm randomized controlled clinical trial |
Masking: | Single (Participant) |
Masking Description: | Using sealed envelopes for either participants or controls |
Primary Purpose: | Treatment |
Official Title: | Role of Ivermectin and Colchicine in Treatment of COVID-19: Randomized Controlled Clinical Trial |
Actual Study Start Date : | July 21, 2021 |
Actual Primary Completion Date : | September 9, 2022 |
Actual Study Completion Date : | December 28, 2022 |
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Arm | Intervention/treatment |
---|---|
Active Comparator: Ivermectin group
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
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Drug: Ivermectin Tablets
oral tablets (0.2 mg/kg/day) single dose on an empty stomach for three successive days.
Other Name: Iverzine |
Active Comparator: Colchicine group
received standard treatment plus Colchicine 0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)
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Drug: Colchicine 0.5 MG
0.5mg tablets (3times/day after meal for 3 days then twice daily for 4 days)
Other Name: Colchicine |
Active Comparator: Control group
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)
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Drug: Standared managment
(Vitamin C 500mg tablet twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75mg tablet once daily for two weeks |
- duration and number of symptoms [ Time Frame: one month ]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)
- Concentration of inflammatory markers (CBC, CRP, Ferritin and D-dimer ) [ Time Frame: one month ]
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
- need for oxygen inhalation [ Time Frame: one month ]Patients were asked to measure oxygen saturation daily and according to the measurement, the need for oxygen was determined.
- need for hospital admission, ICU admission, mechanical ventilation and mortality. [ Time Frame: one month ]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
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930002
Egypt | |
Ain shams university | |
Cairo, Egypt |
Responsible Party: | hemat abdelsalam ahmed, Assistant lecturer of family medicine, Ain Shams University |
ClinicalTrials.gov Identifier: | NCT05930002 |
Other Study ID Numbers: |
Drugs in COVID-19 |
First Posted: | July 5, 2023 Key Record Dates |
Last Update Posted: | July 5, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ivermectin Colchecine COVID-19 |
COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Ivermectin Colchicine Gout Suppressants Antirheumatic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiparasitic Agents Anti-Infective Agents |