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

NCT ID: NCT04344444

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2022-01-05

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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Supportive Care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm B

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

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

tablets provided as described in Arm B

Arm C

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

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

tablets provided as described in Arm B

Azithromycin

Intervention Type: DRUG

tablets provided as described in Arm C

Interventions

Hydroxychloroquine

tablets provided as described in Arm B

Intervention Type: DRUG

Azithromycin

tablets provided as described in Arm C

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LCMC Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meredith Clement, MD

Role: PRINCIPAL_INVESTIGATOR

LSUHSC/UMCNO

Locations

University Medical Center New Orleans

New Orleans, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

COVID 2020-001

Identifier Type: -

Identifier Source: org_study_id