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