Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

NCT04944082 | Unknown Phase 4

• 1 other identifier: Remdesivir-Ivermectin
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Remdesivir only

NO INTERVENTION

(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

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

Drug: Ivermectin

Interventions

Ivermectin DRUG

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

Combination remdesivir plus ivermectin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance \< 30 ml/hr), raised liver enzymes\> 3 folds of normal, arrhythmia.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

  PMID: 32251768 BACKGROUND

• Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15.

  PMID: 32679055 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share