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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A) received both oral and inhaled ivermectin in addition to the standard of care. | Active Comparator | use oral and inhaled ivermectin |
|
| B) received oral ivermectin in addition to the standard of care | Active Comparator | receive oral ivermectin |
|
| c) received inhaled ivermectin in addition to the standard of care | Active Comparator | received inhaled ivermectin |
|
| Group (d) received the current standard of care only | No Intervention | received standard of care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Powder | Drug | - Administration through inhalation (6mg) BID for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment | All PCR for COVID-19 must be negative | througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| resolution of pneumonia | 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. | througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud El-Bendary, M.D | Contact | 00201002592205 | mmelbendary@gmail.com | |
| Hatem Elalfy | Contact | 00201224790518 | elalfy_hatem66@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud El-Bendary, M.D | Mansoura University- Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Faculty of Medicine | Recruiting | Al Mansurah | Dakahlyia | 35516 | Egypt |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 only
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |