Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients.
- Sponsor
- October 6 University
- Study ID
- NCT04779047
- Phase
- PHASE4
- Status
- Unknown
Conditions
- Covid19
- Pneumonia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 88 Years
- Healthy Volunteers
- Not accepted
Interventions
- Remdesivir — DRUGRemdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.
- Hydroxychloroquine — DRUGHydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.
- Tocilizumab — DRUGTocilizumab 800 mg once.
- Lopinavir/ Ritonavir — DRUGLopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
- Ivermectin — DRUGIvermectin 36 mg at day 1,3 and 6.
Study Details
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.
Key Dates
- Start date
- Oct 1, 2020
- Status verified
- Mar 2021
- Primary completion
- Mar 10, 2021
- Completion
- Apr 5, 2021
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: group 1Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once
- Active Comparator: group 2Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.
Primary Outcome Measure
Percentage of clinical cure in each arm [ Time Frame: through an average of 5-7 days ]
Central Contacts
- Ahmed E Abou warda, BSc00201007647696
- Rania M Sarhan, PhD0001008789509
Related Studies
- Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- Study of Lung Proteins in Patients With PneumoniaRecruiting · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
- The Role of Circadian Clock Proteins in Innate and Adaptive ImmunityRecruiting · Washington University School of Medicine · St Louis, Missouri
- Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Recruiting · Duke University · Phoenix, Arizona