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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)

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ClinicalTrials.gov Identifier: NCT04355052
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Itsik Levy Dr, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
COVID - 19 Drug: hydroxychloroquine in combination with camostat mesylate Drug: Hydroxychloroquine in combination of Azithromycin Phase 3

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 years or younger but with risk factors for severe COVID 19 disease will reduce the risk of progression to severe COVID-19 disease compared to hydroxychloroquine plus azithromycin for 5 days or not treating with neither. Severe disease is defined as progression to invasive mechanical ventilation, reduced respiratory parameters (according to NEWS criteria) and 14 and 30-day mortality. This trial will enroll hospitalized consenting adults, who are age 18 or over, have a risk factor for severe disease, have no contraindication to treatment with hydroxychloroquine, can swallow pills, and who do not have severe underlying comorbidity where treatment is not likely to be beneficial to the patient.

The primary outcome will be clinical state of the patient according to NEWS scoring on day 7. Secondary outcomes will be the proportion of participants requiring invasive mechanical ventilation, 14 and 30 -day mortality, and positive viral PCR at day 14.

Randomization will be stratified by age and sex.

Sheba medical center is a tertiary hospital affiliated to Tel Aviv University.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 11, 2020
Estimated Primary Completion Date : October 11, 2020
Estimated Study Completion Date : December 11, 2020


Arm Intervention/treatment
Active Comparator: A - HCQ + AZT
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
Drug: Hydroxychloroquine in combination of Azithromycin
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

Experimental: B - HCQ + CAM
Hydroxychloroquine 400 mg BID on day 1 and than 200 mg BID on days 2-5 + Camostat mesylat 200 mg TID for 10 days
Drug: hydroxychloroquine in combination with camostat mesylate
Two drugs which may act as antivirals against SARS CoVid 2 (Hydroxychloroquine may also act as an immunomodulator, Camostat mesylate is a protease inhibitor)

No Intervention: C - NI
No Intervention



Primary Outcome Measures :
  1. clinical state as reflected by NEWS scoring [ Time Frame: 7 days ]
    the clinical state of the patient regarding respiratory state as defined by the NEWS scoring system

  2. positive PCR [ Time Frame: 7 days ]
    positive PCR SARS COVID 2 in the respiratory system


Secondary Outcome Measures :
  1. prevention of ICU [ Time Frame: 14 days ]
    prevention of hospitaliztion in the ICU

  2. prevention of assisted ventilation [ Time Frame: 14 days ]
    prevention of assisted ventilation

  3. prevention of ECMO [ Time Frame: 14 days ]
    prevention of Extracorporeal Membrane Oxygenation (ECMO)

  4. death [ Time Frame: 14 days ]
    death

  5. positive PCR [ Time Frame: 14 days ]
    positive PCR SARS COVID 2 in the respiratory system


Other Outcome Measures:
  1. death [ Time Frame: 60 days ]
    death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355052


Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Itzchak Levy, MD    97235304937    itsik.levi@sheba.health.gov.il   
Contact: Irit Avisar, RN    97235304937    irit.avisar@sheba.health.gov.il   
Sheba Medical Center Recruiting
Tel HaShomer, Israel, 5237413
Contact: Itzchak Levy, MD    0526667525    itsik.levy@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Itsik Levy Dr, Infectious Disease specialist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04355052    
Other Study ID Numbers: 7092-20-SMC
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Itsik Levy Dr, Sheba Medical Center:
COVID - 19
hydroxychloroquine
camostat mesylate
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Camostat
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors