Remdesivir- Ivermectin Combination Therapy in Severe Covid-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04944082
• Other study ID #: Remdesivir-Ivermectin
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Dulière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	2- Need for ventilator support	either noninvasive or invasive mechanical ventilation.	From date of randomisation to patient discharge from hospital or death.
Primary	3- Length of hospital stay	duration of admission in days	From date of randomisation to date of patient discharge from hospital or death.
Primary	4- Development of complication	allergic reactions, arrhythmia, hepatic toxicity.....	From starting to the end of ivermectin therapy (0 to the end of 4th day)
Primary	5- Mortality	mortality rates in both groups	Through study completion, an average of 3 months