Ivermectin Role in Covid-19 Clinical Trial

Covid19 Clinical Trial

— IRICT  

Official title:

Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746365
• Other study ID #: 1029076
• Secondary ID: 2101001
• Status: Completed
• Phase: Phase 4
• Start date: December 6, 2020
• Est. completion date: February 6, 2021

Study information

• Verified date: February 2021
• Source: Elaraby Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.

Description:

This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 6, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

2. Understands and agrees to comply with planned study procedures.

3. Agrees to the collection of OP swabs and venous blood per protocol.

4. Male or non-pregnant female adult =18 years of age at time of enrollment.

5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other

6. Severe cases according to WHO definition.

Exclusion Criteria:

1. ALT/AST > 5 times the upper limit of normal.

2. Mortality within 12 hours of admission.

3. Pregnancy.

4. Anticipated transfer to another hospital within 24 hours.

5. Allergy to any study medication commercial or public health assay in any specimen prior to randomization.

6. Mechanically ventilated on admission

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• ivermectin
ivermectin is anthelmintic
• hydroxychloroquine
hydroxychloroquine is antimalarial.
• Placebo
Standard treatments

Locations

Country	Name	City	State
Egypt	Shebin-Elkom teaching hospital	Shibin Al Kawm	Menoufia

Sponsors (2)

Lead Sponsor	Collaborator
Elaraby Hospital	Shebin-Elkom Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Grade 3 and 4 adverse events and serious adverse events	14 days
Primary	Reduction in the WHO ordinal scale of clinical status by at least two points	The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome	14 days
Primary	Time to discharge	time to discharge to home after no more need for hospitalization	within 14 days
Secondary	Mortality	All-causes mortality	14 days