Status:
UNKNOWN
Open Label Study to Compare Efficacy, Safety and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in SARS CoV 2 Virus
Lead Sponsor:
Sheba Medical Center
Conditions:
COVID - 19
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
Patients with COVID-19 which are 60 years old or above or with comorbidities are at risk of deteriorating and developing severe illness. This prospective open label study will include people 60 years ...
Detailed Description
This prospective, open-label, placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days plus camostat mesylate for 10 days, initiated in patients older than 60 year...
Eligibility Criteria
Inclusion
- 18 years and above
- COVID-19 confirmed by a real-time RT-PCR tests 7 days prior to clinical trial enrollment
- Mild disease (no pneumonia) with at least one of the following risk factors: Age \> 55, prior lung or kidney disease, DM with HbA1c \> 7.6%, hypertension, CVD, immuno - supressed, organ transplantation, HIV with a CD4 cell count of less than 250 cells/mm3, heavy smoking, BMI \> 30.
- Moderate disease - pneumonia, Tachypnea \> 24 BPM, tachicardia \> 125 BPM, O2 saturation 93% or less
Exclusion
- Severe or critical disase
- Assisted ventilation
- Hospitalization in ICU
- Neutrophiles less than 2000
- AST or ALT \> 5 times normal
- QTc \> 500 msec
- Pregnancy
- Treatment with a drug that prolongs QT
Key Trial Info
Start Date :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 11 2020
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04355052
Start Date
April 11 2020
End Date
December 11 2020
Last Update
April 21 2020
Active Locations (2)
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1
Sheba Medical Center
Ramat Gan, Israel, 52621
2
Sheba Medical Center
Tel Litwinsky, Israel, 5237413