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

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Hydroxychloroquine

Azithromycin

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center New Orleans

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Supportive Care only

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

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

Outcomes

Primary Outcome Measures

Most severe outcome

ordinal outcome of most severe a patient experienced after inpatient admission

Secondary Outcome Measures

Full Information

NCT ID

NCT04344444

First Posted

April 10, 2020

Last Updated

January 5, 2022

Sponsor

LCMC Health

1. Study Identification

Unique Protocol Identification Number

NCT04344444

Brief Title

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

Acronym

RCT

Official Title

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Lack of efficacy data from other studies

Study Start Date

April 13, 2020 (Actual)

Primary Completion Date

April 10, 2021 (Actual)

Study Completion Date

January 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LCMC Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

No Intervention

Arm Description

Supportive Care only

Arm Title

Arm B

Arm Type

Experimental

Arm Description

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

Arm Title

Arm C

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine

Intervention Description

tablets provided as described in Arm B

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Description

tablets provided as described in Arm C

Primary Outcome Measure Information:

Title

Most severe outcome

Description

ordinal outcome of most severe a patient experienced after inpatient admission

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meredith Clement, MD

Organizational Affiliation

LSUHSC/UMCNO

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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