Back to resultsRemdesivir- Ivermectin Combination Therapy in Severe Covid-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ivermectin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
Exclusion Criteria:
- patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance < 30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Remdesivir only
Combination remdesivir plus ivermectin group
Arm Description
(Dose 200 mg day one, 100 mg daily days 2-5), duration may extend to 10 days of remdesivir (200 mg day one, 100 mg daily days 2-10)
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
Outcomes
Primary Outcome Measures
1- Improvement in level of oxygenation
Change in partial pressure of Oxygen and oxygen saturation
2- Need for ventilator support
either noninvasive or invasive mechanical ventilation.
3- Length of hospital stay
duration of admission in days
4- Development of complication
allergic reactions, arrhythmia, hepatic toxicity.....
5- Mortality
mortality rates in both groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944082
Brief Title
Remdesivir- Ivermectin Combination Therapy in Severe Covid-19
Official Title
Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remdesivir only
Arm Type
No Intervention
Arm Description
(Dose 200 mg day one, 100 mg daily days 2-5), duration may extend to 10 days of remdesivir (200 mg day one, 100 mg daily days 2-10)
Arm Title
Combination remdesivir plus ivermectin group
Arm Type
Experimental
Arm Description
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
Primary Outcome Measure Information:
Title
1- Improvement in level of oxygenation
Description
Change in partial pressure of Oxygen and oxygen saturation
Time Frame
By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death
Title
2- Need for ventilator support
Description
either noninvasive or invasive mechanical ventilation.
Time Frame
From date of randomisation to patient discharge from hospital or death.
Title
3- Length of hospital stay
Description
duration of admission in days
Time Frame
From date of randomisation to date of patient discharge from hospital or death.
Title
4- Development of complication
Description
allergic reactions, arrhythmia, hepatic toxicity.....
Time Frame
From starting to the end of ivermectin therapy (0 to the end of 4th day)
Title
5- Mortality
Description
mortality rates in both groups
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
Exclusion Criteria:
patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance < 30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32251768
Citation
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
Results Reference
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PubMed Identifier
32679055
Citation
Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15.
Results Reference
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Learn more about this trial
Remdesivir- Ivermectin Combination Therapy in Severe Covid-19
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