Respiratory Tract Infections
Conditions
Keywords
Levamisole, Isoprinosine, COVID19
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
Interventions
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
DRUGAzithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID 19 induced fever in both groups | 4 weeks | Improvement of fever in degrees celsius |
| COVID 19 induced dyspnea in both groups | 4 weeks | improvement of dyspnea by normalization of respiratory rate |
| COVID 19 viral load in both groups | 4 weeks | PCR of COVID 19 changes from positive to negative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| laboratory clearance in both groups: CRP in mg/dL | 4 weeks | CRP in mg/dL |
Contacts
Primary ContactHagar El Sayed, MD
Backup ContactMohamed El Darouti, Professor
Outcome results
None listed