Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-12-31

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.

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Detailed Description

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Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remdesivir only

(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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Combination remdesivir plus ivermectin group

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

Group Type EXPERIMENTAL

Ivermectin

Intervention Type DRUG

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

Interventions

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Ivermectin

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No