Ivermectin Role in Covid-19 Clinical Trial

• Status: Completed
• Trial end date: 2021-02-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elaraby Hospital
• Collaborators: Shebin El-Kom Teaching Hospital; Shebin-Elkom Teaching Hospital
• Treatments: Hydroxychloroquine; Ivermectin

Criteria

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