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Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331470
Recruitment Status : Unknown
Verified April 2020 by Dr. Siamack Afazeli, Fasa University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : April 2, 2020
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Siamack Afazeli, Fasa University of Medical Sciences

Study Description
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Brief Summary:

New Corona virus (COVID-19) has made a horrible situation for all of the countries. This disease is not only a health problem but also economy, culture and the whole entity of the countries is under attack by the virus. This disease seems to affect the body in two different pathology pathways. From one side virus can decrease activity of immune system in the blood stream and whole body and from other side it can attack the respiratory cells. Tissue biopsy shows that immune cells penetrate into the Lung tissue and we have accumulation and over activity of Immune cells in the lung. This inflammation in respiratory tract probably is the major cause of Cytokine storm and release of TNF-α and IL-6 into the blood.

It seems that by three strategy disease can be treated. 1- By using systemic immune simulators. 2- By using topical anti-inflammatory drug in the respiratory system (Steroids or NSAIDs) 3- By inhibition of replication of the virus in the attacked cells.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Levamisole Pill + Budesonide+Formoterol inhaler Drug: Lopinavir/Ritonavir + hydoxychloroquine Phase 2 Phase 3

Detailed Description:

Looking at the pathology of this disease shows that COVID-19 virus binds to the Angiotensin converting enzyme II (ACE II) which is located on the surface of different cells in the body and specially on the cells of respiratory system. This enzyme is responsible to turn angiotensin II into angiotensin1-7. It is also turns angiotensin I into angiotensin 1-9.

When ACEII would be blocked by virus level of angiotensin II will be increased and this enzyme along with vasoconstriction, makes cells to manufacture TNF α and IL-6 which are responsible for cytokine storm and Lymphopenia. Also presence of virus and virus shell on the surface of the infected cells make immune system to attack to the respiratory system hence effect of angiotensin II inside the cell causes fibrosis of the respiratory cells. This inflammation and tissue damage make Acute Respiratory Distress syndrome (ARDS) which is lethal for patients. There is a dilemma in treatment of this infection. From one side it doesn't make sense to decrease the immune response hence it will make the infection worse. And from other side stimulation of the immune response because of respiratory inflammation can expedite process of lethal ARDS. A new strategy for treatment of this disease which consists of local anti- inflammatory and systemic immune stimulant drugs can be considered as a reasonable strategy.As immunostimulator, Levamisole can increase Lymphocytes and empower the immunity of the body. This drug can also bind to Papaine Like Protease(PL-pro) of the shell of the virus which is necessary for virulence of COVID-19. It also can decrease level of TNF α and IL-6, and as a chemical adjutant can introduce the virus to the immune system. In addition to Levamisole, Formoterol+Budesonide inhaler can be used in this protocol. Budesonide is a steroid and can suppress the immune reaction locally in the respiratory system. Formoterol is β2 agonist and can open airways. It also can bind to PL-pro and can neutralize the virus according to the published articles.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study is two armed , double blind, parallel, randomized clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: All of the research team will be blind about the groups of study and position of patients in each group except of physician and main researcher. Files of patients which will be numbered using a random number table will be sent for analyzer of the study.Information about position of patients in the groups is masked from research team. Outcomes Assessor will receive the information of patients without any name in the file. Just when statistical analysis would be finished information of groups will be revealed.
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Pharmacotherapy Treatment of COVID- 19 Infection Using Oral Levamisole and Formoterol+Budesonide Inhaler and Comparison of This Treatment Protocol With Standard National Treatment of the Disease
Actual Study Start Date : April 4, 2020
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Levamisole Pill + Budesonide+Formoterol inhaler+Standard care
This group will take Levamisole + Budesonide/Formoterol along side with standard treatment regime.
 Drug: Levamisole Pill + Budesonide+Formoterol inhaler
Levamisole 50 mg tablet has to be taken 1-2 tablets every 8 hours Budesonide+Formoterol has to be inhaled 1-2 puff every 12 hours
Other Name: Levamisole and Budesonide+Formoterol inhaler both are generic drugs.

Drug: Lopinavir/Ritonavir + hydoxychloroquine
Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
Other Name: Kaletra+ Generic Hydroxy Chloroquine( Generic Drug)
Active Comparator: Standard care
This group will take standard treatment regime introduced by Ministry of health.
 Drug: Lopinavir/Ritonavir + hydoxychloroquine
Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
Other Name: Kaletra+ Generic Hydroxy Chloroquine( Generic Drug)


Outcome Measures
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Primary Outcome Measures :
  1. Clear chest CT-scan [ Time Frame: between 3-7 days ]
    Chest Ct scan should be negative

  2. PCR test [ Time Frame: between 3-7 days ]
    PCR test should be negative


Secondary Outcome Measures :
  1. Physical statues of patient [ Time Frame: Between 3-7 days ]
    Patient should relief from signs of disease


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Definitely positive COVID-19 patients

Exclusion Criteria:

Patients with acute respiratory problems including patients with:

  1. Spo2<60%
  2. Severe respiratory distress
  3. Heamodynamic instabilitty
  4. Acid base disturbance
  5. Severe Anemia Patients with severe hepatic diseases Patients with Nurvous system diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331470


Contacts
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Contact: Siamack Afazeli, Pharm.D +989121392982 Dr.afazeli@gmail.com
Contact: Mojtaba Farjaam, MD +989177104789 farjam.md@gmail.com

Locations
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Iran, Islamic Republic of
Vali-Asr Hospital Recruiting
Fasa, Fars, Iran, Islamic Republic of
Contact: Jalal Karimi, PhD    +987153314026    info@fums.ac.ir   
Contact: Yousef Gholampoor, PhD    +987153314021    info@fums.ac.ir   
Sponsors and Collaborators
Fasa University of Medical Sciences
Investigators
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Principal Investigator: Siamack Afazeli Fasa University of Medical Sciences
More Information
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Additional Information:

Publications:
Potential inhibitors against papain-like protease of novel coronavirus (COVID-19) from FDA approved drugs ,Rimanshee Arya1, Amit Das1, Vishal Prashar1,*, Mukesh Kumar1, 2,* 1Radiation Biology & Health Sciences Division, Bhabha Atomic Research Centre, Trombay, Mumbai-400085, India 2Homi Bhabha National Institute, Mumbai-400094, India

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Siamack Afazeli, Doctor, Fasa University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04331470    
Other Study ID Numbers: 97548
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication and is comply with ethics will be revealed.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: between 1 to 2 months after analyzing the raw data.
Access Criteria: Results will be available in Journals.
URL: http://journal.fums.ac.ir/en

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
Lopinavir
Chloroquine
 Levamisole
Hydroxychloroquine
Budesonide
Formoterol Fumarate
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors