Respiratory Tract InfectionsPhase 3NCT04383717
Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
A Phase 3 study testing Levamisole and isoprinosine and Azithromycin and hydroxychloroquine in people with Respiratory Tract Infections, run by Cairo University.
Trial summary
The use of both levamisole \& Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Levamisole and isoprinosine and Azithromycin and hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2020to 30 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mohamed El Darouti, Professor contact
About this study
Official title: The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
The use of both levamisole \& Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection
Read the 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
- Conditions
- Respiratory Tract Infections
- Being tested
- Levamisole and isoprinosine, Azithromycin and hydroxychloroquine
- Keywords
- Levamisole, Isoprinosine, COVID19
- Medical subject headings
- Respiratory Tract Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levamisole and isoprinosineDrug
Also called ketrax and inosiplex
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 hydroxychloroquineDrug
Also called Zithromax and plaquinel
oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
| Study group | Role | What they receive |
|---|---|---|
| Proposed treatment group | Active comparator | Levamisole and isoprinosine Receives: Drug: Levamisole and isoprinosine |
| Control group | Active comparator | hydroxychloroquine and azithromycin Receives: Drug: Azithromycin and hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID 19 induced fever in both groups
Improvement of fever in degrees celsius
Measured: 4 weeks
COVID 19 induced dyspnea in both groups
improvement of dyspnea by normalization of respiratory rate
Measured: 4 weeks
COVID 19 viral load in both groups
PCR of COVID 19 changes from positive to negative
Measured: 4 weeks
Secondary outcomes (1)
laboratory clearance in both groups: CRP in mg/dL
CRP in mg/dL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start5 May 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
- Investigators
- Mohamed El Darouti, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383717
- Sponsor's protocol ID
- Levamisole and isoprinosine
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
- ClinicalTrials.gov ID
- NCT04383717
- Acronym / sponsor ID
- Levamisole and isoprinosine
- Conditions
- Respiratory Tract Infections
- Keywords
- Levamisole, Isoprinosine, COVID19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 May 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proposed treatment group | Active comparator | Drug: Levamisole and isoprinosineLevamisole and isoprinosine |
| Control group | Active comparator | Drug: Azithromycin and hydroxychloroquinehydroxychloroquine and azithromycin |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levamisole and isoprinosineAlso: ketrax and inosiplexoral tablets levamisole 50 mg 3 times daily every other day for 2 weeks Isoprinosine oral tablets 1 g 4 times daily for 2 weeks | Drug | Proposed treatment group |
| Azithromycin and hydroxychloroquineAlso: Zithromax and plaquineloral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily | Drug | Control group |
Primary outcome
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
1 secondary outcome
laboratory clearance in both groups: CRP in mg/dL
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed El Darouti, Professor contact
Mohamed El Darouti, Professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levamisole and isoprinosine and Azithromycin and hydroxychloroquine in people with Respiratory Tract Infections, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagar El Sayed, MD (0223682030, hgr_ntr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID 19 induced fever in both groups (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.