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Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04944082
Enrollment
60
Registered
2021-06-29
Start date
2021-07-01
Completion date
2021-12-31
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DRUGIvermectin

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1- Improvement in level of oxygenationBy 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 deathChange in partial pressure of Oxygen and oxygen saturation
2- Need for ventilator supportFrom date of randomisation to patient discharge from hospital or death.either noninvasive or invasive mechanical ventilation.
3- Length of hospital stayFrom date of randomisation to date of patient discharge from hospital or death.duration of admission in days
4- Development of complicationFrom starting to the end of ivermectin therapy (0 to the end of 4th day)allergic reactions, arrhythmia, hepatic toxicity.....
5- MortalityThrough study completion, an average of 3 monthsmortality rates in both groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026