Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Phase 4

• Conditions: Covid19
• Interventions: Drug: Ivermectin

• Registration Number: NCT04944082
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29
• Study Start: 2021-07-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination remdesivir plus ivermectin group	Ivermectin	(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)

Primary Outcome Measures

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