Ivermectin Role in Covid-19 Clinical Trial (IRICT)

Elaraby Hospital

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Drug: Placebo; Drug: hydroxychloroquine; Drug: ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT04746365

2101001 (Registry Identifier)

1029076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 3 patient groups, including a placebo group

ivermectin

Experimental group

Description:

ivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours

Treatment:

Drug: ivermectin

hydroxychloroquine

Experimental group

Description:

hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days

Treatment:

Drug: hydroxychloroquine

Placebo

Placebo Comparator group

Description:

Unlabelled standard treatment according to the clinical condition of patients

Treatment:

Drug: Placebo