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

Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04383717
• Other study ID #: Levamisole and isoprinosine
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 5, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2020
• Source: Cairo University
• Contact: Hagar El Sayed, MD
• Phone: 0223682030
• Email: hgr_ntr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Infections

Intervention

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
• Azithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID 19 induced fever in both groups	Improvement of fever in degrees celsius	4 weeks
Primary	COVID 19 induced dyspnea in both groups	improvement of dyspnea by normalization of respiratory rate	4 weeks
Primary	COVID 19 viral load in both groups	PCR of COVID 19 changes from positive to negative	4 weeks
Secondary	laboratory clearance in both groups: CRP in mg/dL	CRP in mg/dL	4 weeks