Ivermectin In Treatment of COVID 19 Patients

NCT04425707 | Unknown

• 1 other identifier: 14-2020/3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• to evaluate the role of Ivermectin as a line of treatment for COVID 19

  the role of ivermectin in the cure of COVID 19 patients

  2 months

Secondary Outcomes (1)

• To asses the rate of viral clearance in comparison to other treatment protocols.

  2 months

Study Arms (3)

A ivermectin alone

EXPERIMENTAL

ivermectin will be administarted alone to COVID 19 patients

Drug: Ivermectin

B standard care alone

EXPERIMENTAL

standard care will be administarted alone

Drug: Ivermectin

C ivermectin added to standard of care

ACTIVE COMPARATOR

ivermectin will be administarted in adition to standard care

Drug: Ivermectin

Interventions

Ivermectin DRUG

use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt

Also known as: hydroxychloroquine

A ivermectin alone; B standard care alone; C ivermectin added to standard of care

Eligibility Criteria

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

You may qualify if:

• Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap

You may not qualify if:

• Contraindications for the drug: hypersensitivity.
• Any medications with possible drug interactions.
• Severe cases.
• Any malignant condition.
• Pregnant females.
• Breast feeding females.
• Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.

Sponsors & Collaborators

• Ministry of Health and Population, Egypt: lead

Study Sites (1)

isolation and referal hospitals for COVID 19 patients

Cairo, Egypt

RECRUITING

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 Officials

• houssam ho masoud, MD

  COVID sceintific comittee ministry of health and population

  STUDY DIRECTOR

Central Study Contacts

ehab ah kamal, MD

CONTACT

01006162663; ehabkamal2011@hotmail.com

noha mo asem, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general director of fever hospitals

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 9, 2020
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

EG (1)