search
Back to results

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

Primary Purpose

Respiratory Tract Infections

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levamisole and isoprinosine
Azithromycin and hydroxychloroquine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections focused on measuring Levamisole, Isoprinosine, COVID19

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Proposed treatment group

    Control group

    Arm Description

    Levamisole and isoprinosine

    hydroxychloroquine and azithromycin

    Outcomes

    Primary Outcome Measures

    COVID 19 induced fever in both groups
    Improvement of fever in degrees celsius
    COVID 19 induced dyspnea in both groups
    improvement of dyspnea by normalization of respiratory rate
    COVID 19 viral load in both groups
    PCR of COVID 19 changes from positive to negative

    Secondary Outcome Measures

    laboratory clearance in both groups: CRP in mg/dL
    CRP in mg/dL

    Full Information

    First Posted
    May 4, 2020
    Last Updated
    May 11, 2020
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04383717
    Brief Title
    Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
    Official Title
    The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 5, 2020 (Anticipated)
    Primary Completion Date
    August 30, 2020 (Anticipated)
    Study Completion Date
    October 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Tract Infections
    Keywords
    Levamisole, Isoprinosine, COVID19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Proposed treatment group
    Arm Type
    Active Comparator
    Arm Description
    Levamisole and isoprinosine
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    hydroxychloroquine and azithromycin
    Intervention Type
    Drug
    Intervention Name(s)
    Levamisole and isoprinosine
    Other Intervention Name(s)
    ketrax and inosiplex
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin and hydroxychloroquine
    Other Intervention Name(s)
    Zithromax and plaquinel
    Intervention Description
    oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
    Primary Outcome Measure Information:
    Title
    COVID 19 induced fever in both groups
    Description
    Improvement of fever in degrees celsius
    Time Frame
    4 weeks
    Title
    COVID 19 induced dyspnea in both groups
    Description
    improvement of dyspnea by normalization of respiratory rate
    Time Frame
    4 weeks
    Title
    COVID 19 viral load in both groups
    Description
    PCR of COVID 19 changes from positive to negative
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    laboratory clearance in both groups: CRP in mg/dL
    Description
    CRP in mg/dL
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hagar El Sayed, MD
    Phone
    0223682030
    Email
    hgr_ntr@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed El Darouti, Professor
    Phone
    0223682030
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed El Darouti, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs