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

April 9, 2020 updated by: Dr. Siamack Afazeli, Fasa University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 96 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Kaletra+ Generic Hydroxy Chloroquine( Generic Drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clear chest CT-scan
Time Frame: between 3-7 days
Chest Ct scan should be negative
between 3-7 days
PCR test
Time Frame: between 3-7 days
PCR test should be negative
between 3-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical statues of patient
Time Frame: Between 3-7 days
Patient should relief from signs of disease
Between 3-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fasa University of Medical Sciences

Investigators

  • Principal Investigator: Siamack Afazeli, Fasa university of medical sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2020

Primary Completion (Anticipated)

April 20, 2020

Study Completion (Anticipated)

May 20, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication and is comply with ethics will be revealed.

IPD Sharing Time Frame

between 1 to 2 months after analyzing the raw data.

IPD Sharing Access Criteria

Results will be available in Journals.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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