CCOVID-19: Inhaled Ivermectin and COVID-19

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04681053

Collaborator

(none)

Enrollment

Location

Arms

10.2

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies.

The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ivermectin Powder	Phase 3

Detailed Description

Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2 virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are responsible for viral replication and transcription while its protease enzymes are responsible for polypeptides cleaving and immune system blockage. They are considered to be an important therapeutic target.

Host immunological response against SARS-CoV2 could affect the disease outcome. Patients requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α (TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is associated with pulmonary damage and respiratory distress.

Till now, there is no definitive therapy for COVID-19. Multiple current and investigational drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.

Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity against a broad range of viruses. It inhibits the interaction between the human immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and "subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All current study participants will be classified into 4 equal groups : Group (A) received both oral and inhaled ivermectin in addition to the standard of care. Group (B)received inhaled ivermectin only Group (C) received oral ivermectin in addition to the standard of care, Group (D) received the current standard of care onlyAll current study participants will be classified into 4 equal groups : Group (A) received both oral and inhaled ivermectin in addition to the standard of care. Group (B)received inhaled ivermectin only Group (C) received oral ivermectin in addition to the standard of care, Group (D) received the current standard of care only

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)

Anticipated Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group (A) received both oral and inhaled ivermectin in addition to the standard of care. use oral and inhaled ivermectin	Drug: Ivermectin Powder - Administration through inhalation (6mg) BID for 3 days Other Names: Direct antiviarl agents
Active Comparator: B) received oral ivermectin in addition to the standard of care receive oral ivermectin	Drug: Ivermectin Powder - Administration through inhalation (6mg) BID for 3 days Other Names: Direct antiviarl agents
Active Comparator: c) received inhaled ivermectin in addition to the standard of care received inhaled ivermectin	Drug: Ivermectin Powder - Administration through inhalation (6mg) BID for 3 days Other Names: Direct antiviarl agents
No Intervention: Group (d) received the current standard of care only received standard of care only

Outcome Measures

Primary Outcome Measures

Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment [througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).]
All PCR for COVID-19 must be negative

Secondary Outcome Measures

resolution of pneumonia [througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).]
The score severity index of pneumonia will be measured before and after receiving treatment by computed tomography (CT)(index from 0-20)increasing the index means increase severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Both sexes
Age above 18
Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
Willing to participate in the study
Mild to moderate severity index according to the WHO criteria

Exclusion Criteria:

Hypersensitivity to the study drug.
History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
Women who are pregnant or breastfeeding.