Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Tract Infections | Drug: Levamisole and isoprinosine Drug: Azithromycin and hydroxychloroquine | Phase 3 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Proposed treatment group
Levamisole and isoprinosine
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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
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Drug: Azithromycin and hydroxychloroquine
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
Other Name: Zithromax and plaquinel |
- COVID 19 induced fever in both groups [ Time Frame: 4 weeks ]Improvement of fever in degrees celsius
- COVID 19 induced dyspnea in both groups [ Time Frame: 4 weeks ]improvement of dyspnea by normalization of respiratory rate
- COVID 19 viral load in both groups [ Time Frame: 4 weeks ]PCR of COVID 19 changes from positive to negative
- laboratory clearance in both groups: CRP in mg/dL [ Time Frame: 4 weeks ]CRP in mg/dL

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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 |
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

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
Contact: Hagar El Sayed, MD | 0223682030 | hgr_ntr@yahoo.com | |
Contact: Mohamed El Darouti, Professor | 0223682030 |
Principal Investigator: | Mohamed El Darouti, Professor | Cairo University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Levamisole Isoprinosine COVID19 |
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 |