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Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344444
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
LCMC Health

Brief Summary:
This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Phase 3

Detailed Description:

This is a phase 3 study.

Primary Objective:

• To evaluate clinical outcomes in patients with suspected or confirmed COVID-19 with early moderate to severe disease in a randomized controlled trial.

Secondary Objectives:

  • To evaluate quantitative viral load over time
  • To evaluate length of hospital stay and days in ICU
  • To evaluate toxicity of the treatment options
  • To evaluate rate of readmission after hospital discharge
  • To evaluate duration of clinical symptoms

Arm A:

Control Arm - Supportive Care Only

Arm B:

Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5

Arm C:

Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial
Estimated Study Start Date : April 10, 2020
Estimated Primary Completion Date : April 10, 2021
Estimated Study Completion Date : December 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Arm A
Supportive Care only
Experimental: Arm B
Hydroxychloroquine 400 mg po bid on Day 1 Hydroxychloroquine 200 mg po bid Days 2 through 5
Drug: Hydroxychloroquine
tablets provided as described in Arm B

Experimental: Arm C
Hydroxychloroquine as in Arm B AND Azithromycin 500 mg po on Day 1 Azithromycin 250 mg po days 2 through 5
Drug: Hydroxychloroquine
tablets provided as described in Arm B

Drug: Azithromycin
tablets provided as described in Arm C




Primary Outcome Measures :
  1. Most severe outcome [ Time Frame: 5 days ]
    ordinal outcome of most severe a patient experienced after inpatient admission



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 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 years
  • Positive SARS-CoV-2 testing or consistent clinical syndrome (based on clinical picture e.g. characteristic infiltrates on chest x-ray, laboratory findings, and with agreement by two physicians) in patients under investigation (PUIs).
  • Onset of symptoms < 7 days from date of enrollment
  • Oxygen saturation of >94% on room air with defined risk factors (Table 1) consistent with moderate disease OR oxygen saturation of < 94% on room air consistent with severe disease
  • Ability and willingness to comply with study procedures

Exclusion Criteria:

  • QTc greater than 450 milliseconds on screening EKG
  • Pregnant or lactating women
  • Inability to take oral pills or inability to use a feeding tube
  • Inability to obtain informed consent either from the patient or from the next of kin if patient is incapacitated. For the purpose of this study obtaining a verbal consent from a family member on the phone with a witness will be considered acceptable since there is a 'no visitor' policy in force at hospitals.
  • Patients requiring ICU level care
  • use of azithromycin or hydroxychloroquine within 30 days prior to admission

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): NCT04344444


Contacts
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Contact: Jeannine Ascani, MS 5047023141 jeannine.ascani@lcmchealth.org

Locations
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United States, Louisiana
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Jeannine Ascani    504-702-3141    jeannine.ascani@lcmchealth.org   
Sponsors and Collaborators
LCMC Health
Investigators
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Principal Investigator: Meredith Clement, MD LSUHSC/UMCNO
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Responsible Party: LCMC Health
ClinicalTrials.gov Identifier: NCT04344444    
Other Study ID Numbers: COVID 2020-001
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents