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

NCT04331470 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 97548
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Clear chest CT-scan

  Chest Ct scan should be negative

  between 3-7 days

• PCR test

  PCR test should be negative

  between 3-7 days

Secondary Outcomes (1)

• Physical statues of patient

  Between 3-7 days

Study Arms (2)

Levamisole Pill + Budesonide+Formoterol inhaler+Standard care

EXPERIMENTAL

This group will take Levamisole + Budesonide/Formoterol along side with standard treatment regime.

Drug: Levamisole Pill + Budesonide+Formoterol inhaler; Drug: Lopinavir/Ritonavir + hydoxychloroquine

Standard care

ACTIVE COMPARATOR

This group will take standard treatment regime introduced by Ministry of health.

Drug: Lopinavir/Ritonavir + hydoxychloroquine

Interventions

Levamisole Pill + Budesonide+Formoterol inhaler DRUG

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

Also known as: Levamisole and Budesonide+Formoterol inhaler both are generic drugs.

Levamisole Pill + Budesonide+Formoterol inhaler+Standard care

Lopinavir/Ritonavir + hydoxychloroquine DRUG

Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours

Also known as: Kaletra+ Generic Hydroxy Chloroquine( Generic Drug)

Levamisole Pill + Budesonide+Formoterol inhaler+Standard care; Standard care

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitely positive COVID-19 patients

You may not qualify if:

• Patients with acute respiratory problems including patients with:
• Spo2\<60%
• Severe respiratory distress
• Heamodynamic instabilitty
• Acid base disturbance
• Severe Anemia Patients with severe hepatic diseases Patients with Nurvous system diseases

Sponsors & Collaborators

• Fasa University of Medical Sciences: lead

Study Sites (1)

Vali-Asr Hospital

Fasa, Fars, Iran

RECRUITING

Related Publications (19)

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• 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

  BACKGROUND

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  PMID: 32738928 DERIVED

Related Links

• Potential inhibitors against papain-like protease of novel coronavirus (COVID-19) from FDA approved drugs

MeSH Terms

Conditions

COVID-19

Interventions

Levamisole; Lopinavir; Ritonavir; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Siamack Afazeli

  Fasa University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siamack Afazeli, Pharm.D

CONTACT

+989121392982; Dr.afazeli@gmail.com

Mojtaba Farjaam, MD

CONTACT

+989177104789; farjam.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Study is two armed , double blind, parallel, randomized clinical trial.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: April 4, 2020
• Primary Completion: April 20, 2020
• Study Completion: May 20, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: between 1 to 2 months after analyzing the raw data.
• Access Criteria: Results will be available in Journals.

Locations

IR (1)