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
COSTA
An Open-Label Study to Compare the Efficacy, Safety, and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in Hospitalized Patients Suffering From a Mild or Moderate SARS CoV 2 Virus
1 other identifier
interventional
250
1 country
2
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 old or above or younger if at risk for severe disease. Individuals confirmed to have SARS-CoV-2 infection will be identified using medical records screening. They will then be offered to participate in the study and if agree will be given the informed consent. After examining inclusion and exclusion criteria they will be asked to sign the informed consent and after signing Information like immunizations, ECG results, diagnostic images and reports, written medical reports, diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number) will be gathered. Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to one of three arms: hydroxychloroquine + azithromycin, hydroxychloroquine + camostat mesylate or "doing nothing" in a ratio of 2:1:2. Study drug will be dispensed by the hospital pharmacy. Follow up will continue for 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2020
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 11, 2020
CompletedApril 21, 2020
April 1, 2020
6 months
April 16, 2020
April 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
clinical state as reflected by NEWS scoring
the clinical state of the patient regarding respiratory state as defined by the NEWS scoring system
7 days
positive PCR
positive PCR SARS COVID 2 in the respiratory system
7 days
Secondary Outcomes (5)
prevention of ICU
14 days
prevention of assisted ventilation
14 days
prevention of ECMO
14 days
death
14 days
positive PCR
14 days
Other Outcomes (1)
death
60 days
Study Arms (3)
A - HCQ + AZT
ACTIVE COMPARATORHydroxychloroquine 400 mg BID on day 1 and than 200 mg BID on days 2-5 + Azithromycin 500 mg QD on day 1 and 250 mg QD on days 2-5
B - HCQ + CAM
EXPERIMENTALHydroxychloroquine 400 mg BID on day 1 and than 200 mg BID on days 2-5 + Camostat mesylat 200 mg TID for 10 days
C - NI
NO INTERVENTIONNo Intervention
Interventions
Two drugs which may act as antivirals against SARS CoVid 2 (Hydroxychloroquine may also act as an immunomodulator, Camostat mesylate is a protease inhibitor)
Hydroxychloroquine 400 mg BID on day 1 and than 200 mg BID on days 2-5 + Azithromycin 500 mg QD on day 1 and 250 mg QD on days 2-5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sheba Medical Center
Ramat Gan, 52621, Israel
Sheba Medical Center
Tel Litwinsky, 5237413, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Infectious Disease specialist
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 21, 2020
Study Start
April 11, 2020
Primary Completion
October 11, 2020
Study Completion
December 11, 2020
Last Updated
April 21, 2020
Record last verified: 2020-04