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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shaukat Khanum Memorial Cancer Hospital & Research Centre | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
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The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.
To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy.
Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study.
The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine and Montelukast | Group 1 was given Standard of care (SOC) + HCQ + Montelukast |
| |
| Montelukast | Group 2 was given Standard of care (SOC) + Montelukast |
| |
| Hydroxychloroquine | Group 3 was given Standard of care (SOC) + HCQ |
| |
| Hydroxychloroquine, Montelukast and Invermectin | Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | An FDA approved medicine to treat asthmatic patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients admittance to ICU | Changes in the number of ICU visits of COVID-19 patients | 2 Week |
| Length of total stay at the hospital | Changes in the length of total stay of patients at the hospital | 2 weeks |
| Alleviating the symptoms of COVID-19 | Monitoring the changes in disease severity with alleviation of the symptoms | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin levels | Monitoring the Interleukin levels with the progression of treatments | 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, MD | Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China | Principal Investigator |
| Muhammad Rehman Akram, MBBS | Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China | Shanghai | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D006886 | Hydroxychloroquine |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Teesside University | OTHER |
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Nasal Swab samples
| Hydroxychloroquine | Drug | An FDA approved antiarthritis drug |
|
| Ivermectin | Drug | An FDA approved anti-parasitic medicine |
|
| Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan | Lahore | Punjab Province | 54600 | Pakistan |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |