Ivermectin Role in Covid-19 Clinical Trial

NCT04746365 | Completed Phase 4

• 2 other identifiers: 10290762101001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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

• Time to discharge

  time to discharge to home after no more need for hospitalization

  within 14 days

Secondary Outcomes (1)

• Mortality

  14 days

Other Outcomes (1)

• Adverse events

  14 days

Study Arms (3)

ivermectin

EXPERIMENTAL

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

Drug: ivermectin

hydroxychloroquine

EXPERIMENTAL

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

Drug: hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Unlabelled standard treatment according to the clinical condition of patients

Drug: Placebo

Interventions

ivermectin DRUG

ivermectin is anthelmintic

ivermectin

hydroxychloroquine DRUG

hydroxychloroquine is antimalarial.

hydroxychloroquine

Placebo DRUG

Standard treatments

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.
• Agrees to the collection of OP swabs and venous blood per protocol.
• Male or non-pregnant female adult ≥18 years of age at time of enrollment.
• Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
• Severe cases according to WHO definition.

You may not qualify if:

• ALT/AST \> 5 times the upper limit of normal.
• Mortality within 12 hours of admission.
• Pregnancy.
• Anticipated transfer to another hospital within 24 hours.
• Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
• Mechanically ventilated on admission

Sponsors & Collaborators

• Elaraby Hospital: lead
• Shebin El-Kom Teaching Hospital: collaborator

Study Sites (1)

Shebin-Elkom teaching hospital

Shibīn al Kawm, Menoufia, Egypt

Location

Related Publications (1)

• Elshafie AH, Elsawah HK, Hammad M, Sweed EM, Seif AS, Abdel Ghaffar MM, Goda FM, Mosalam EM, Abdallah MS. Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trial. Expert Rev Anti Infect Ther. 2022 Oct;20(10):1341-1350. doi: 10.1080/14787210.2022.2098113. Epub 2022 Jul 12.

  PMID: 35788169 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; Hydroxychloroquine

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; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Unlabelled tablets were prepared for each patient in a special envelope in a time-based manner in the central pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: Randomized, double-blinded, controlled clinical trial

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 9, 2021
• Study Start: December 6, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 6, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

EG (1)