Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Covid19

Treatments: Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT04944082

Remdesivir-Ivermectin

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Remdesivir only

No Intervention group

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)

Combination remdesivir plus ivermectin group

Experimental group

Description:

(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)

Treatment:

Drug: Ivermectin