NCT04394442UnknownPhase 2
Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
Samah Lutfy1 site in 1 country200 target enrollmentStarted: March 21, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- time to viral clearance
Study Overview
Brief Summary
Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed cases of SARS-CoV-2 by PCR
Exclusion Criteria
- •less than 18 years old known hypersensitivity to the drug
Arms & Interventions
Hydroxycholoroquine group
Experimental
Intervention: Hydroxychloroquine (Drug)
Outcomes
Primary Outcomes
time to viral clearance
Time Frame: 21 days after patients randomization
PCR will be done every 72 h day till 2 consecutive negative PCR tests(24h apart) which is the viral clearance.The time between randomization and viral clearance is the viral clearance time
% of mortality
Time Frame: 60 days after randomization
total number of deaths divided by total number of the group
Secondary Outcomes
- need for mechanical ventilation(60 days after randomization)
- Length of stay(60 days after randomization)
- time to be afebrile(60 days after randomization)
Investigators
Samah Lutfy
Assistant professor of chest diseases
Zagazig University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19Pneumonia, PneumocystisCoronavirusCOVID-19NCT04261517Shanghai Public Health Clinical Center30
Terminated
Phase 2
Treating COVID-19 With Hydroxychloroquine (TEACH)COVID-19NCT04369742NYU Langone Health128
Completed
Phase 2
Efficacay of Chloroquine or Hydroxychloroquine in COVID-19 TreatmentCOVID-19Coronavirus InfectionNCT04353336Tanta University194
Completed
Phase 1
High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19COVID-19NCT04351620University of Chicago12
Terminated
Phase 2
Hydroxychloroquine for the Treatment of Mild COVID-19 DiseaseCOVID-19NCT04340544University Hospital Tuebingen17