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Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial

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: NCT04383717
Recruitment Status : Unknown
Verified May 2020 by Hagar El Sayed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hagar El Sayed, Cairo University

Study Description
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Brief Summary:
The use of both levamisole & Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Drug: Levamisole and isoprinosine Drug: Azithromycin and hydroxychloroquine Phase 3

Detailed Description:

Study design: Randomized controlled trial, randomization by closed envelope technique Informed consent will be written for each patient of either group

At the beginning of the study all patients will have the following investigations done: CBC with differential, ESR, PCR for COVID 19, D dimer and CT chest and confirmed cases will included in the study

Pregnant and lactating women together with children with other comorbidities will be excluded from the study

Study groups:

Duration of the study is 4 weeks

Both groups with persistent COVID 19 symptoms that require hospitalization

Group 1: 30 patients with confirmed COVID19 infection and sharing clinical features like fever, malaise, sore throat, runny nose, persistent cough &dyspnea, requiring hospitalization

Group 2: control group: 30 patients

Treatment endpoint • Cure of patients: Improvement of symptoms Laboratory findings ESR and total leucocytic count returning to normal PCR negative Radiological improvement

• Worsening of symptoms or fatalities

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Proposed treatment group
Levamisole and isoprinosine
 Drug: Levamisole and isoprinosine
oral tablets levamisole 50 mg 3 times daily every other day for 2 weeks Isoprinosine oral tablets 1 g 4 times daily for 2 weeks
Other Name: ketrax and inosiplex
Active Comparator: Control group
hydroxychloroquine and azithromycin
 Drug: Azithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
Other Name: Zithromax and plaquinel


Outcome Measures
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Primary Outcome Measures :
  1. COVID 19 induced fever in both groups [ Time Frame: 4 weeks ]
    Improvement of fever in degrees celsius

  2. COVID 19 induced dyspnea in both groups [ Time Frame: 4 weeks ]
    improvement of dyspnea by normalization of respiratory rate

  3. COVID 19 viral load in both groups [ Time Frame: 4 weeks ]
    PCR of COVID 19 changes from positive to negative


Secondary Outcome Measures :
  1. laboratory clearance in both groups: CRP in mg/dL [ Time Frame: 4 weeks ]
    CRP in mg/dL


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COVID 19 infection (positive PCR, elevated ESR, leucopenia)
  • Clinical picture of COVID 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose

Exclusion Criteria:

  • Mild cases of COVID 19 that do not require hospitalization
  • Pregnant & lactating women
  • Children with other comorbidities
  • People who received previous treatment for COVID 19 in the last 2 weeks N.B. Diabetes and hypertension not excluded
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): NCT04383717


Contacts
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Contact: Hagar El Sayed, MD 0223682030 hgr_ntr@yahoo.com
Contact: Mohamed El Darouti, Professor 0223682030

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohamed El Darouti, Professor Cairo University
More Information
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Responsible Party: Hagar El Sayed, Dermatology Lecturer Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04383717    
Other Study ID Numbers: Levamisole and isoprinosine
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hagar El Sayed, Cairo University:
Levamisole
Isoprinosine
COVID19
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
Azithromycin
Hydroxychloroquine
Levamisole
 Inosine Pranobex
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antinematodal Agents
Anthelmintics
Antiviral Agents