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

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Most severe outcome	ordinal outcome of most severe a patient experienced after inpatient admission	5 days

Collaborators and Investigators

• Sponsor: LCMC Health
• Investigators: Principal Investigator: Meredith Clement, MD, LSUHSC/UMCNO

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): April 10, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: COVID 2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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