Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Study Overview
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Brief Summary
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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.

Official Title
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Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: Ivermectin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Remdesivir only<br>(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) | |
| Experimental: Combination remdesivir plus ivermectin group<br>(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days) | Drug: Ivermectin<br>* (The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- Improvement in level of oxygenation | Change in partial pressure of Oxygen and oxygen saturation | 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 | 
| 2- Need for ventilator support | either noninvasive or invasive mechanical ventilation. | From date of randomisation to patient discharge from hospital or death. | 
| 3- Length of hospital stay | duration of admission in days | From date of randomisation to date of patient discharge from hospital or death. | 
| 4- Development of complication | allergic reactions, arrhythmia, hepatic toxicity..... | From starting to the end of ivermectin therapy (0 to the end of 4th day) | 
| 5- Mortality | mortality rates in both groups | Through study completion, an average of 3 months |