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

NCT04344444 | Terminated Phase 3 FDA Drug

• 1 other identifier: COVID 2020-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Most severe outcome

  ordinal outcome of most severe a patient experienced after inpatient admission

  5 days

Study Arms (3)

Arm A

NO INTERVENTION

Supportive Care only

Arm B

EXPERIMENTAL

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

Drug: Hydroxychloroquine

Arm C

EXPERIMENTAL

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

Drug: Hydroxychloroquine; Drug: Azithromycin

Interventions

Hydroxychloroquine DRUG

tablets provided as described in Arm B

Arm B; Arm C

Azithromycin DRUG

tablets provided as described in Arm C

Arm C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LCMC Health: lead

Study Sites (1)

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Meredith Clement, MD

  LSUHSC/UMCNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: April 13, 2020
• Primary Completion: April 10, 2021
• Study Completion: January 5, 2022
• Last Updated: January 21, 2022

Record last verified: 2020-08

Locations

US (1)